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One anastomosis gastric bypass (OAGB) may expose the patient to certain specific complications. Here, we report the results of conversion of OAGB to Roux-en-Y gastric bypass (RYGB) in terms of outcomes and weight loss.Between January 2009 and January 2019, all patients undergoing conversion of OAGB to RYGB because of complications due to OAGB (n = 23) were included. The primary efficacy endpoint was the effectiveness of converting OAGB to RYGB. The secondary endpoints were overall mortality and morbidity during the first 3 postoperative months, specific morbidity, reoperation, length of hospitalization, weight loss, and progression of comorbidities related to obesity at 2-year follow-up.Indications for conversion were bile reflux (n = 14; 60.9%), severe malnutrition (n = 3; 13%), gastro-gastric fistula (n = 4; 17.4%), and anastomotic leak (n = 2; 8.7%). The median time interval between OAGB and conversion to RYGB was 34 months (0-158). At the time of RYGB, median body mass index (BMI) was 28.0 kg/mRYGB performed as revisional surgery for complications after OAGB is an effective procedure with no major weight regain at 2 years of follow-up.

Background The prevalence of obesity and the number of bariatric surgeries in both the general population and in patients with inflammatory bowel disease (IBD) have increased significantly in recent years. Due to small sample sizes and the lack of adequate controls, no definite conclusions can be drawn from the available studies on the safety and efficacy of bariatric surgery (BS) in patients with IBD. Our aim was to assess safety, weight loss, and deficiencies in patients with IBD and obesity who underwent BS and compare findings to a control group. Methods Patients with IBD and a history of BS were retrospectively recruited to centers belonging to the Groupe d’Etude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Patients were matched 1:2 for age, sex, body mass index (BMI), hospital of surgery, and type of BS with non-IBD patients who underwent BS. Complications, rehospitalizations, weight, and deficiencies after BS were collected in cases and controls. Results We included 88 procedures in 85 patients (64 Crohn’s disease, 20 ulcerative colitis, 1 unclassified IBD) with a mean BMI of 41.6 ± 5.9 kg/m2. Bariatric surgery included Roux-en-Y gastric bypass (n = 3), sleeve gastrectomy (n = 73), and gastric banding (n = 12). Eight (9%) complications were reported, including 4 (5%) requiring surgery. At a mean follow-up of 34 months, mean weight was 88.6 ± 22.4 kg. No difference was observed between cases and controls for postoperative complications (P = .31), proportion of weight loss (P = .27), or postoperative deficiencies (P = .99). Conclusions Bariatric surgery is a safe and effective procedure in patients with IBD and obesity; outcomes in this patient group were similar to those observed in a control population.

Background The incidence of gastric poorly cohesive carcinoma (PCC) is increasing. The prognosis for patients with peritoneal metastases remains poor and the role of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is controversial. The aim was to clarify the impact of gastric PCC with peritoneal metastases treated by CRS with or without HIPEC. Methods All patients with peritoneal metastases from gastric cancer treated with CRS with or without HIPEC, in 19 French centres, between 1989 and 2014, were identified from institutional databases. Clinicopathological characteristics and outcomes were compared between PCC and non-PCC subtypes, and the possible benefit of HIPEC was assessed. Results In total, 277 patients were included (188 PCC, 89 non-PCC). HIPEC was performed in 180 of 277 patients (65 per cent), including 124 of 188 with PCC (66 per cent). Median overall survival (OS) was 14.7 (95 per cent c.i. 12.7 to 17.3) months in the PCC group versus 21.2 (14.7 to 36.4) months in the non-PCC group (P Conclusion In selected patients, CRS-HIPEC offers acceptable outcomes among those with gastric PCC and long survival for patients without PCC.

Gastric sleeve stenosis (GSS) is described in 1%-4% of patients.To evaluate the role of endoscopy in the management of stenosis after laparoscopic sleeve gastrectomy using a standardized approach according to the characteristic of stenosis.Retrospective, observational, single-center study on patients referred from several bariatric surgery departments to an endoscopic referral center.We enrolled 202 patients. All patients underwent endoscopy in a fluoroscopy setting, and a systematic classification of the type, site, and length of the GSS was performed. According to the characteristics of the stenosis, patients underwent pneumatic dilatation or placement of a self-expandable metal stent or a lumen-apposed metal stent. Failure of endoscopic treatment was considered an indication for redo surgery, whereas patients with partial or complete response were followed up for 2 years. In the event of a recurrence, a different endoscopic approach was used.We found inflammatory strictures in 4.5% of patients, pure narrowing in 11%, and functional stenosis in 84.5%. Stenosis was in the upper tract of the stomach in 53 patients, whereas medium and distal stenosis was detected in 138 and 11 patients, respectively, and short stenosis in 194 patients. A total of 126 patients underwent pneumatic dilatation, 8 self-expandable metal stent placement, 64 lumen-apposed metal stent positioning, and 36 combined therapy. The overall rate of endoscopy success was 69%.GSS should be considered to be a chronic disease, and the endoscopic approach seems to be the most successful treatment, with a prolonged positive outcome of 69%. Characteristics of the stenosis should guide the most suitable endoscopic approach. (Surg Obes Relat Dis 2022;X:XXX-XXX.) © 2022 American Society for Metabolic and Bariatric Surgery. All rights reserved.

Nutritional care after bariatric surgery is an issue of major importance, especially insofar as risk of deficiency has been extensively described in the literature. Subsequent to the deliberations carried out by a multidisciplinary working group, we are proposing a series of recommendations elaborated using the Delphi-HAS (official French health authority) method, which facilitates the drawing up of best practice and consensus recommendations based on the data of the literature and on expert opinion. The recommendations in this paper pertain to dietary management and physical activity, multivitamin and trace element supplementation and the prevention and treatment of specific deficiencies in vitamins B1, B9, B12, D and calcium, iron, zinc, vitamins A, E and K, dumping syndrome and reactive hypoglycemia.

Resume La prise en charge nutritionnelle apres chirurgie bariatrique est un enjeu majeur car le risque de carences est largement decrit dans la litterature. Sur la base des travaux d’un groupe de travail multidisciplinaire, nous proposons des recommandations etablies a l’aide de la methode Delphi- HAS (Haute Autorite de Sante) qui permet a la fois l’elaboration de recommandations de bonne pratique et de consensus reposant sur des donnees de la litterature ou des avis d’experts. Ces recommandations portent sur la prise en charge dietetique et l’activite physique, les supplementations en multivitamines et oligo-elements, la prevention et le traitement des carences specifiques en vitamines B1, B9, B12, D et calcium, fer, zinc, vitamines A, E et K, du dumping syndrome et des hypoglycemies reactionnelles.

Background Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. Methods/design The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient’s health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. Discussion The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. Trial registration ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.

Resume L’adenocarcinome gastrique (AG) est, au niveau mondial, le 5e cancer le plus frequent, la decroissance de son incidence semble se stabiliser en France. Vingt-cinq experts reunis sous l’egide de l’Association francaise de chirurgie ont collabore a la redaction de ce referentiel dedie a la prise en charge chirurgicale de l’AG. Concernant le bilan pre-therapeutique, la realisation d’une echo-endoscopie chez tous les patients candidats a une exerese chirurgicale (afin de preciser le statut ganglionnaire) et d’une cœlioscopie exploratrice en cas d’AG cT3/T4 et/ou N+ a la recherche d’une carcinose peritoneale a ete retenue. Cependant, le TEP-scanner ne devrait pas etre realise systematiquement mais uniquement lorsque les autres modalites diagnostiques sont insuffisantes. La laparotomie reste la voie d’abord de choix pour la realisation d’une gastrectomie totale ou partielle avec curage ganglionnaire D2 pour les lesions > T2N0. Il est recommande de faire un reservoir jejunal sur anse-en-Y pour le retablissement de continuite apres gastrectomie totale afin de limiter le risque de dumping syndrome et de reflux œsophagien. En cas de carcinose peritoneale sur AG avec PCI limite (≤ 7) chez un patient en bon etat general et dont la maladie est controlee par chimiotherapie, il faut probablement realiser une cytoreduction macroscopiquement complete avec chimiotherapie hyperthermique intraperitoneale en centre expert. Une gastrectomie avec curage D2 peut etre envisagee en cas de cirrhose uniquement si Child A. La realisation d’une gastrectomie palliative a visee symptomatique ou une derivation chirurgicale en cas d’obstruction distale de l’estomac chez un patient en bon etat general peuvent etre envisagees.

Summary Background The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to cytoreductive surgery has been associated with encouraging survival results in some patients with colorectal peritoneal metastases who were eligible for complete macroscopic resection. We aimed to assess the specific benefit of adding HIPEC to cytoreductive surgery compared with receiving cytoreductive surgery alone. Methods We did a randomised, open-label, phase 3 trial at 17 cancer centres in France. Eligible patients were aged 18–70 years and had histologically proven colorectal cancer with peritoneal metastases, WHO performance status of 0 or 1, a Peritoneal Cancer Index of 25 or less, and were eligible to receive systemic chemotherapy for 6 months (ie, they had adequate organ function and life expectancy of at least 12 weeks). Patients in whom complete macroscopic resection or surgical resection with less than 1 mm residual tumour tissue was completed were randomly assigned (1:1) to cytoreductive surgery with or without oxaliplatin-based HIPEC. Randomisation was done centrally using minimisation, and stratified by centre, completeness of cytoreduction, number of previous systemic chemotherapy lines, and timing of protocol-mandated systemic chemotherapy. Oxaliplatin HIPEC was administered by the closed (360 mg/m2) or open (460 mg/m2) abdomen techniques, and systemic chemotherapy (400 mg/m2 fluorouracil and 20 mg/m2 folinic acid) was delivered intravenously 20 min before HIPEC. All individuals received systemic chemotherapy (of investigators' choosing) with or without targeted therapy before or after surgery, or both. The primary endpoint was overall survival, which was analysed in the intention-to-treat population. Safety was assessed in all patients who received surgery. This trial is registed with ClinicalTrials.gov , NCT00769405 , and is now completed. Findings Between Feb 11, 2008, and Jan 6, 2014, 265 patients were included and randomly assigned, 133 to the cytoreductive surgery plus HIPEC group and 132 to the cytoreductive surgery alone group. After median follow-up of 63·8 months (IQR 53·0–77·1), median overall survival was 41·7 months (95% CI 36·2–53·8) in the cytoreductive surgery plus HIPEC group and 41·2 months (35·1–49·7) in the cytoreductive surgery group (hazard ratio 1·00 [95·37% CI 0·63–1·58]; stratified log-rank p=0·99). At 30 days, two (2%) treatment-related deaths had occurred in each group.. Grade 3 or worse adverse events at 30 days were similar in frequency between groups (56 [42%] of 133 patients in the cytoreductive surgery plus HIPEC group vs 42 [32%] of 132 patients in the cytoreductive surgery group; p=0·083); however, at 60 days, grade 3 or worse adverse events were more common in the cytoreductive surgery plus HIPEC group (34 [26%] of 131 vs 20 [15%] of 130; p=0·035). Interpretation Considering the absence of an overall survival benefit after adding HIPEC to cytoreductive surgery and more frequent postoperative late complications with this combination, our data suggest that cytoreductive surgery alone should be the cornerstone of therapeutic strategies with curative intent for colorectal peritoneal metastases. Funding Institut National du Cancer, Programme Hospitalier de Recherche Clinique du Cancer, Ligue Contre le Cancer.

Resume Situation La sleeve gastrectomie laparoscopique (SGL) et le bypass gastrique en Y laparoscopique (BPGYL) sont couramment effectues, mais peu d’etudes ont montre la superiorite d’une strategie par rapport a l’autre. Objectif Comparer simultanement la SGL et le BPGYL en termes de perte de poids et de morbi-mortalite sur une periode de suivi de 36 mois. Methodes Etude prospective et comparative entre la SGL et le BPGYL. L’objectif principal de cette etude etait une hypothese conjointe testee au cours d’un suivi de 36 mois : le premier critere principal concernait la frequence de patients presentant une perte d’exces de poids (PEP) superieure a 50 % (% PEP > 50 %) apres SGL et BPGYL ; le deuxieme critere principal etait un critere composite defini comme la survenue d’au moins une complication majeure. Les objectifs secondaires devaient rapporter la regression des comorbidites et l’amelioration de la qualite de vie. Resultats Deux cent soixante dix-sept patients ont participe a l’etude (91 BPGYL, 186 SGL). L’âge moyen etait de 41,1 ± 11,1 ans, et l’indice de masse corporelle preoperatoire moyen de 45,3 ± 5,5 kg/m2. Apres 36 mois, le % PEP > 50 % n’etait pas inferieur dans le groupe SGL (82,2 %) par rapport au groupe BPGYL (82,1 %) ; pendant que le taux de complications majeurs etait significativement plus eleves apres BPGYL (15,4 %) qu’apres SGL (5,4 %, p = 0,005). Apres 36 mois, les objectifs secondaires etaient comparables entre les groupes alors que le reflux gastro-œsophagien (RGO) a augmente dans le groupe SGL et a diminue dans le groupe BPGYL. Conclusions La SGL a ete non inferieure au BPGYL pour ce qui concerne la perte de poids et etait associee a un taux plus faible de complications majeures au cours d’un suivi de 3 ans. Mais le RGO a augmente dans le groupe SGL et a diminue dans le groupe BPGYL.

Iron deficiency with or without anemia, needing continuous iron supplementation, is very common in obese patients, particularly those requiring bariatric surgery. The aim of this study was to address the impact of weight loss on the rescue of iron balance in patients who underwent sleeve gastrectomy (SG), a procedure that preserves the duodenum, the main site of iron absorption. The cohort included 88 obese women, sampling of blood and duodenal biopsies of 35 patients were performed before and one year after SG. An analysis of the 35 patients consisted in evaluating iron homeostasis including hepcidin, markers of erythroid iron deficiency (soluble transferrin receptor (sTfR) and erythrocyte protoporphyrin (PPIX)), expression of duodenal iron transporters (DMT1 and ferroportin) and inflammatory markers. After surgery, sTfR and PPIX were decreased. Serum hepcidin levels were increased despite the significant reduction in inflammation. DMT1 abundance was negatively correlated with higher level of serum hepcidin. Ferroportin abundance was not modified. This study shed a new light in effective iron recovery pathways after SG involving suppression of inflammation, improvement of iron absorption, iron supply and efficiency of erythropoiesis, and finally beneficial control of iron homeostasis by hepcidin. Thus, recommendations for iron supplementation of patients after SG should take into account these new parameters of iron status assessment.

To retrospectively characterize the molecular features of Non-Small Cell Lung Carcinomas (NSCLC) with peritoneal carcinomatosis (PC), clinicopathological data of 12 patients diagnosed with NSCLC and PC between 2007 and 2016 were collected. Immunohistochemistry and Next Generation Sequencing (NGS) were performed on cases with available material. PC was the initial presentation of NSCLC in 17% of the cases. Overall, patients with PC displayed a poor median survival of 12 weeks. Histology was adenocarcinoma in 11 cases. 37.5% of cases showed PD-L1 immunostaining positivity (50% cut-off). ALK and ROS1 immunostainings were negative. Using NGS, we identified 17 molecular alterations in 9 genes (TP53, KRAS, STK11, BRAF, EGFR, DDR2, ERBB4, SMAD4, CTNNB1) in 88.9% of adenocarcinomas. To the best of our knowledge, 5 of these variants are not referenced in the literature. In conclusion, PC might be the initial presentation of NSCLC. Molecular profiling of our cases did not find any effective targetable alteration, except from high PD-L1 expression.

In obesity, platelets are described as hyperactive, mainly based on increased platelet size and presence of pro-thrombotic plasmatic molecules. We explored platelet functions, including calcium signalling in obesity, and the effect of weight loss. We included 40 obese patients (women with body mass index [BMI] of ≥ 35 kg/m2) who were to undergo gastric bypass surgery and 40 healthy lean subjects (women with BMI of

International audience; No abstract available

International audience; Importance: Available data comparing the long-term results of hybrid minimally invasive esophagectomy (HMIE) with that of open esophagectomy are conflicting, with similar or even better results reported for the minimally invasive esophagectomy group. Objective: To evaluate the long-term, 5-year outcomes of HMIE vs open esophagectomy, including overall survival (OS), disease-free survival (DFS), and pattern of disease recurrence, and the potential risk factors associated with these outcomes. Design, Setting, and Participants: This randomized clinical trial is a post hoc follow-up study that analyzes the results of the open-label Multicentre Randomized Controlled Phase III Trial, which enrolled patients from 13 different centers in France and was conducted from October 26, 2009, to April 4, 2012. Eligible patients were 18 to 75 years of age and were diagnosed with resectable cancer of the middle or lower third of the esophagus. After exclusions, patients were randomized to either the HMIE group or the open esophagectomy group. Data analysis was performed on an intention-to-treat basis from November 19, 2019, to December 4, 2020. Interventions: Hybrid minimally invasive esophagectomy (laparoscopic gastric mobilization with open right thoracotomy) was compared with open esophagectomy. Main Outcomes and Measures: The primary end points of this follow-up study were 5-year OS and DFS. The secondary end points were the site of disease recurrence and potential risk factors associated with DFS and OS. Results: A total of 207 patients were randomized, of whom 175 were men (85%), and the median (range) age was 61 (23-78) years. The median follow-up duration was 58.2 (95% CI, 56.5-63.8) months. The 5-year OS was 59% (95% CI, 48%-68%) in the HMIE group and 47% (95% CI, 37%-57%) in the open esophagectomy group (hazard ratio [HR], 0.71; 95% CI, 0.48-1.06). The 5-year DFS was 52% (95% CI, 42%-61%) in the HMIE group vs 44% (95% CI, 34%-53%) in the open esophagectomy group (HR, 0.81; 95% CI, 0.55-1.17). No statistically significant difference in recurrence rate or location was found between groups. In a multivariable analysis, major intraoperative and postoperative complications (HR, 2.21; 95% CI, 1.41-3.45; P

Background Endoscopy plays a pivotal role in the management of adverse events (AE) following bariatric surgery. Leaks, fistulae, and post-operative collection after sleeve gastrectomy (SG) may occur in up to 10% of cases. Objectives To evaluate the efficacy and safety of endoscopic internal drainage (EID) for the management of leak, fistula, and collection following SG. Setting Retrospective, observational, single center study on patients referred from several bariatric surgery departments to an endoscopic referral center. Methods EID was used as first-line treatment for the management of leaks, fistulae, and collections. Leaks and fistulae were treated with double pigtail stent (DPS) deployment in order to guarantee internal drainage and second intention cavity obliteration. Collections were treated with endoscropic ultrasound (EUS)–guided deployment of DPS or lumen apposing metal stents. Results A total of 617 patients (83.3% female; mean age, 43.1 yr) were enrolled in the study for leak (n = 300, 48.6%), fistula (n = 285, 46.2%), and collection (n = 32, 5.2%). Median follow-up was 19.5 months. Overall clinical success was 84.7% whereas 15.3% of cases required revisional surgery after EID failure. Clinical success according to type of AE was 89.5%, 78.5%, and 90% for leak, fistula, and collection, respectively. A total of 10 of 547 (1.8%) presented a recurrence during follow-up. A total of 28 (4.5%) AE related to the endoscopic treatment occurred. At univariate logistic regression predictors of failure were: fistula (OR 2.012), combined endoscopic approach (OR 2.319), need for emergency surgery (OR 1.755), and previous endoscopic treatment (OR 4.818). Conclusion Early EID for the management of leak, fistula, and post-operative collection after SG seems a safe and effective first-line approach with good long-term results.

Multiple randomized controlled trials have demonstrated the short term benefits of (hybrid) minimally invasive esophagectomy (MIE) over open esophagectomy. Data regarding long term results are more conflicting with similar or even better results in the MIE arm. In this follow-up study of the MIRO-trial we evaluated the long-term 5-year outcomes including overall survival (OS), disease-free survival (DFS) as well as the pattern of disease recurrence, along with evaluation of potential prognostic factors affecting these outcomes. Methods From October 2009 till April 2012, we conducted a multicentre, open-label, prospective, randomized, controlled trial including patients who were diagnosed with thoracic esophageal cancer and eligible for curative surgical resection (Ivor-Lewis procedure). Patients were randomized between hybrid minimally invasive esophagectomy and open esophagectomy. The primary end-point of the initial MIRO trial was major intra- and postoperative complication (Clavien-Dindo ≥2) within 30 days after surgery. The primary end-points of this follow-up study were OS and DFS. Additional secondary end points were defined as site of disease recurrence and potential prognostic or mediating factors associated with DFS and OS. Results 207 patients underwent randomization. The median follow-up was 58,2 (95% CI, 56,5– 63,8) months. The 5y OS was 59% (95% CI, 48–68) and 47% (95% CI, 37–57) in the hybrid- and open-procedure group respectively (HR, 0,71, 95% CI, 0,48-1,06). The 5y DFS was 52% (95% CI, 42–61) in the hybrid-procedure group vs. 44% (95%CI, 34–53) in the open-procedure group. (HR 0.81 (95% CI, 0,55-1,17). There was no significant difference in recurrence rate (p = 0.519) or -location (p = 0.692) between groups. In a multivariate analysis, major postoperative and pulmonary complications were identified as prognostic factors of impaired OS (p Conclusion Besides a significant reduction in postoperative overall and pulmonary complication rate, minimally invasive (hybrid) esophagectomy offers long-term oncological results that are at least equivalent to open esophagectomy. Postoperative and pulmonary complications are independent prognostic factors for impaired overall- and disease-free survival, providing additional proof that minimally invasive esophagectomy could even be associated with better long-term oncological results compared to open esophagectomy mediated by a reduction in postoperative complications.

Background Series comparing gastric banding (GB) removal and sleeve gastrectomy (SG) when procedures are performed as a 1- or a 2-step approach are contradictory in their outcomes. No series comparing these approaches with midterm weight loss is available. Objectives Compare the outcomes and weight loss of SG performed as 1- and 2-step approaches as a revisional procedure for GB failure. Setting University Hospital, France, public practice. Methods Between February 2006 and January 2017, all patients undergoing SG with a previous history of implementation of GB (n = 358) were included in this 2-center, retrospective, observational study. Revisional surgery was proposed in patients with insufficient excess weight loss (excess weight loss ≤50%) or weight regain after GB. A 1-step (1-step group, n = 270) or 2-step (2-step group, n = 88) approach was decided depending on patient’s choice and/or surgeon’s preference. The primary efficacy endpoint was the comparison of weight loss in the 1- and 2-step groups at the 2-year follow-up. The secondary efficacy endpoints were short-term outcomes (overall mortality and morbidity at postoperative day 30, specific morbidity, reoperation, length of hospital stay, and readmission). Results In the 1-step group, the mean preoperative body mass index before SG was 40.5 kg/m2 (27.0–69.0), while in the 2-step group, the mean preoperative body mass index was 43.5 kg/m2 (31.5–61.7). Mean operating time was 109 minutes (50–240) in the 1-step group and 78.7 minutes (40–175) in the 2-step group (P = .22). In the 1-step group, 6 conversions to laparotomy occurred, while in the 2-step group, 2 conversions to laparotomy occurred (P = .75). One death (.2%, in the 2-step group) and 39 complications (30 in the 1-step group [11.1%] and 9 in the 2-step group [10.2%]) also occurred. The mean length of hospital stay was 6.2 days in the 1-step group and 4.1 days in the 2-step group. At 2-year follow-up, mean body mass index was 32.4 kg/m2 in the 1-step group and 33.2 kg/m2 in the 2-step group (P = .15), representing excess weight losses of 61.9 and 50.1 (P = .05), respectively. The rates of revisional surgery were .7% and 2.2%, respectively. Conclusions SG after previous GB is efficient with similar outcomes depending on the 1- or 2-step approach. The 1-step approach seems to have increased weight loss compared with the 2-step approach.

International audience; No abstract available

Resume Face a l’emergence de la pandemie a COVID 19, l’activite de chirurgie bariatrique/metabolique a ete arretee. Le confinement et l’arret de cette chirurgie ont eu un impact sous-estime sur la population obese avec prise de poids, et aggravation des comorbidites. Un certain nombre de candidats a cette chirurgie sont exposes a un risque important de mortalite liee a la pandemie. En effet, l’obesite et le diabete sont deux facteurs de risque majeurs de forme grave d’infection a COVID-19. Le seul traitement efficace actuel de l’obesite est la chirurgie metabolique avec un benefice rapide et durable. Il parait donc necessaire de reprendre une activite de chirurgie metabolique. Le but de ce travail est de hierarchiser la reprise chirurgicale afin qu’elle soit progressive et coherente. Les organigrammes proposes aideront les centres a determiner les patients prioritaires selon la balance benefice-risque. Le diabete a une place centrale dans l’arbre decisionnel. Les modalites de reprise seront variables d’un centre a l’autre selon les ressources humaines, materielles et medicamenteuses, et seront a adapter a l’evolution epidemique. Un consentement eclaire specifique sera necessaire. Un depistage chez les patients obeses est a envisager dont les modalites de depistage sont elaborees sur la base des connaissances disponibles. En cas de suspicion de COVID, la chirurgie doit etre differee. Il faut insister sur les mesures et gestes barrieres afin de proteger le patient et le personnel soignant. Un confinement est fortement suggere pour le patient durant le premier mois postoperatoire. Le suivi des patients sera effectue de preference par teleconsultation.

Summary Background Plasma citrulline is currently used in clinical practice as a marker of small bowel functional mass. Behaviour of plasma citrulline after bariatric surgery and its link with post-operative outcome are still poorly understood. Objective Primary objective was to compare plasma citrulline 12 months after two types of bariatric surgery with pre-operative concentrations. Secondary objectives were to search for correlation between plasma citrulline variation and body weight and fat mass loss. Design This is an ancillary study of the BARIASPERM study. Forty-six adult men (mean age 38.9 ± 7.9 years) who underwent gastric bypass (GB, n = 20) or sleeve gastrectomy (SG, n = 26) were included in this prospective study. Plasma citrulline was measured at baseline, 6 months and 12 months after surgery, as well as total body weight and fat mass measured by dual x-ray absorptiometry (DEXA). Results Plasma citrulline increased significantly 12 months after surgery, both after gastric bypass and sleeve gastrectomy (respectively 30.2% [18.3–42.2] and 17.8% [5.8–29.7]). The increase was significantly higher after GB than after SG (p = 0.02) while total body weight and fat mass loss were not significantly different between GB and SG. The increase in plasma citrulline levels tended to be positively correlated with both weight and fat mass loss however the association did not reach statistical significance (p = 0.07 and p = 0.06 respectively). Conclusion These results confirm the increase in plasma citrulline after GB published in two previous small studies. Citrulline also significantly increased after SG, and in spite of similar weight loss obtained with both surgery types, citrulline increase was higher after GB than SG. This suggests different modifications of intestinal functional mass after these two different techniques.

Although bariatric surgery is proven to sustain weight loss in morbidly obese patients, long-term adverse effects have yet to be fully characterized. This study compared the long-term consequences of two common forms of bariatric surgery: one-anastomosis gastric bypass (OAGB) and Roux-en-Y Gastric Bypass (RYGB) in a preclinical rat model. We evaluated the influence of biliopancreatic limb (BPL) length, malabsorption, and bile acid (BA) reflux on esogastric mucosa. After 30 weeks of follow-up, Wistar rats operated on RYGB, OAGB with a short BPL (15 cm, OAGB-15), or a long BPL (35 cm, OAGB-35), and unoperated rats exhibit no cases of esogastric cancer, metaplasia, dysplasia, or Barrett’s esophagus. Compared to RYGB, OAGB-35 rats presented higher rate of esophagitis, fundic gastritis and perianastomotic foveolar hyperplasia. OAGB-35 rats also revealed the greatest weight loss and malabsorption. On the contrary, BA concentrations were the highest in the residual gastric pouch of OAGB-15 rats. Yet, no association could be established between the esogastric lesions and malabsorption, weight loss, or gastric bile acid concentrations. In conclusion, RYGB results in a better long-term outcome than OAGB, as chronic signs of biliary reflux or reactional gastritis were reported post-OAGB even after reducing the BPL length in a preclinical rat model.

International audience; OBJECTIVE: The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS). SUMMARY BACKGROUND DATA: DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study. METHODS: We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed. RESULTS: A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P \textless 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P \textless 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%. CONCLUSIONS: The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.

Hybrid minimally invasive esophagectomy (HMIE) has been shown to reduce major postoperative complications compared with open esophagectomy (OE) for esophageal cancer.The aim of this study was to compare short- and long-term health-related quality of life (HRQOL) following HMIE and OE within a randomized controlled trial.We performed a multicenter, open-label, randomized controlled trial at 13 study centers between 2009 and 2012. Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus were randomized to undergo either transthoracic OE or HMIE. Patients were followed-up every 6 months for 3 years postoperatively and global health assessed with EORTC-QLQC30 and esophageal symptoms assessed with EORTC-OES18.The short-term reduction in global HRQOL at 30 days specifically role functioning [-33.33 (HMIE) vs -46.3 (OE); P = 0.0407] and social functioning [-16.88 (HMIE) vs -35.74 (OE); P = 0.0003] was less substantial in the HMIE group. At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303). At 2 years, increases in pain were similarly reduced in the HMIE compared with the OE group [+6.94 (HMIE) vs +14.05 (OE); P = 0.018]. Postoperative complications in multivariate analysis were associated with role functioning, pain, and dysphagia.Esophagectomy has substantial effects upon short-term HRQOL. These effects for some specific parameters are, however, reduced with HMIE, with persistent differences up to 2 years, and maybe mediated by a reduction in postoperative complications.

Resume La chirurgie bariatrique ameliore le devenir des patients. La sleeve gastrectomie (SG) est une procedure simple, codifiee, avec une duree operatoire courte et un taux de complications majeures relativement faible (taux de fistule gastrique de 3 % et taux d’hemorragie sur la ligne d’agrafage gastrique de moins de 5 %) qui repond aux criteres de la chirurgie ambulatoire. L’analyse de trois etudes recentes de larges cohortes montrent que le taux de complications est faible ainsi que les echecs de la procedure de prise en charge tandis que le degre de satisfaction des patients est eleve. Ces resultats encouragent le developpement de cette chirurgie en ambulatoire.

Background Roux-en-Y gastric bypass (RYGB) is considered the gold standard for surgical management of morbid obesity due to its good results on weight loss and correction of comorbidities related to obesity. However, RYGB could have some adverse effect in the mid and long term. Here, we describe simple technique for laparoscopic reversal of RYGB into normal anatomy. Methods The video shows our laparoscopic technique of the reversal of RYGB that was performed for severe protein deficiency. A 35-year-old woman with history of RYGB was referred to our center for restoration of normal digestive anatomy. Results A 35-year-old woman was managed for severe protein deficiency 3 years after RYGB. Renutrition was performed using peripherally inserted central catheter but nutritional status was dependent on PICC. No gastrostomy tube was implemented at the time where the patient was referred because the reversal of RYGB was decided. We found a modified RYGB with a common channel of 130 cm, an alimentary channel of 350 cm, and a biliopancreatic limb of 70 cm. Revision to normal digestive anatomy was performed using linear staplers, resection of 15 cm of the small bowel, and only one small bowel anastomosis. An uneventful post-operative course enabled rapid discharge (post-operative day 5). At 6-month follow-up, there was no more protein deficiency and the patient had acceptable weight regain. Conclusion Reversal of RYGB is not usual and can be performed safely with few small bowel sacrifices. The optimization of pre-operative nutritional status is necessary to avoid complications.

Hypothermia is associated with an increased postoperative morbidity and mortality. Forced-air warming systems are the most effective methods for its prevention. When using a mattress, a reduction in the area of diffusion of warm air by crushing due to excess weight cannot be ruled out. We designed a prospective study to compare the efficacy of a forced-air warming mattress (Bair Hugger® 585) to prevent hypothermia (core temperature (CT°)

Background Lifelong medical follow-up is mandatory after bariatric surgery. The aim of this study was to assess the 5-year follow-up after bariatric surgery in a nationwide cohort of patients. Methods All adult obese patients who had undergone primary bariatric surgery in 2009 in France were included. Data were extracted from the French national health insurance database. Medical follow-up (medical visits, micronutrient supplementation and blood tests) during the first 5 years after bariatric surgery was assessed, and compared with national and international guidelines. Results Some 16 620 patients were included in the study. The percentage of patients with at least one reimbursement for micronutrient supplements decreased between the first and fifth years for iron (from 27.7 to 24.5 per cent; P < 0.001) and calcium (from 14·4 to 7·7 per cent; P < 0·001), but increased for vitamin D (from 33·1 to 34·7 per cent; P < 0·001). The percentage of patients with one or more visits to a surgeon decreased between the first and fifth years, from 87·1 to 29·6 per cent (P < 0·001); similar decreases were observed for visits to a nutritionist/endocrinologist (from 22·8 to 12·4 per cent; P < 0·001) or general practitioner (from 92·6 to 83·4 per cent; P < 0·001). The mean number of visits to a general practitioner was 7·0 and 6·1 in the first and the fifth years respectively. In multivariable analyses, male sex, younger age, absence of type 2 diabetes and poor 1-year follow-up were predictors of poor 5-year follow-up. Conclusion Despite clear national and international guidelines, long-term follow-up after bariatric surgery is poor, especially for young men with poor early follow-up.

Aim Subtotal colectomy is the treatment of last resort in patients with severe colonic inertia (SCI) refractory to laxatives. Some studies have reported hypoplasia of the interstitial cells of Cajal (ICC) using a semi-quantitative analysis. The aims of this study were first to investigate if semi-quantitative or morphometry is better at the quantification of colonic ICC and secondly to determine whether there is a relationship between the number of ICC and the severity of constipation. Method Clinical and pathological data from patients with subtotal colectomy for SCI were collected. Quantification of ICC using CD117 immunohistochemistry and morphometric methods was performed at three different colonic sites in patients and controls. Results Twenty patients had a colectomy for SCI. All were considered to have failed maximal medical treatment and 45 % were hospitalized at least once for colonic obstruction due to faecaloma. Using a semi-quantitative methodology, 30 % of patients displayed ICC hypoplasia (< 7 per high power field (HPF)) and all controls had normal ICC. Using morphometry, the percentage of colonic ICC was significantly less in patients compared with controls with no significant differences between the ascending, transverse and descending colonic segments. Overall 60 % of patients had ICC hypoplasia (< 1% vs. 20 % of controls [p = 0.009]). The severity of constipation was not related to the quantity of ICC. Conclusion In patients with SCI, morphometric analysis is more sensitive than semi-quantitative analysis in the detection of ICC hypoplasia. The severity of constipation was not related to the quantity of ICC. This article is protected by copyright. All rights reserved.

Background The use of ursodeoxycholic acid (UDCA) to prevent gallstone formation after gastric bypass (RYGB) is still debated. Furthermore, only 1 study has assessed the effectiveness of UDCA after sleeve gastrectomy (SG) with mitigated results. Objectives To compare the incidence of cholelithiasis (CL) between patients treated or not treated with UDCA after RYGB and SG. Setting University hospital, France. Methods Since January 2008, a postoperative ultrasound monitoring was scheduled for all patients without previous cholecystectomy who underwent bariatric surgery in our institution. Patients who underwent at least 1 ultrasound in the first postoperative year (±6 months) were included. We started to systematically prescribe UDCA (500 mg/d) for 6 months postoperatively, in February 2012 for RYGB (once or twice daily) and in October 2013 for SG (once daily). Results Mean follow-up was 13.0±3.4 months. The incidence of CL was 32.5% in the 117 nontreated RYGB and 25.5% in the 51 nontreated SG. It was reduced to 2.4% in the 42 SG treated once daily ( P = .005), to 5.7% in the 87 RYGB with 250 mg twice daily ( P P = .03). Conclusion UDCA 500 mg once daily for 6 months is efficient to prevent CL 1 year after SG, but the twice-daily doses seem to be more effective after RYGB. The effectiveness of UDCA once daily after SG and the superiority of the twice-daily doses after RYGB should be confirmed with more patients and longer follow-up.

International guidelines emphasize the need for multidisciplinary preparation to improve the safety and effectiveness of bariatric surgery (BS), but whether the patient is ready for surgery is difficult to assess. The objective of this study was to explore whether inquiries on dietary habits and physical activity before surgery are predictive of postoperative weight loss. We prospectively assessed in 78 candidates for BS (age, 43 ± 12 years; M/F, 15/63; weight, 122 ± 17 kg; IMC, 44 ± 5 kg/m2) anthropometric parameters, food intake, and physical activity (Baecke questionnaire) at the beginning and the end of a systematized preoperative preparation (7 ± 2 months) including consultations (mean number 7 ± 2) with a nutritionist, dietician, psychologist, and sports coach. During the preparation, weight change was zero (±5 kg). In contrast, self-reported caloric intake decreased from 2143 ± 640 to 1906 ± 564 kcal/24 h (p

International audience; Purpose: Psammocarcinoma (PK) is a rare disease of unknown origin. We aimed to report the characteristics, management and survival of patients operated on for PK within the French Network for Rare Peritoneal Malignancies (RENAPE) expert centers.Patients and methods: All consecutive cases of PK operated within all 26 RENAPE centers between 1997 and 2018 were retrospectively analyzed.Results: Twenty-five patients were identified. The median age was 53 years [range 17–78]. None of the patients had extra peritoneal metastases at diagnosis. A median of 6 cycles of carboplatin-based systemic chemotherapy was delivered in 52% preoperatively (n = 13) and 56% postoperatively (n = 14); associated with placlitaxel for 12 patients. All patients were operated on. The median PCI was 23 [0–33]. Eighty-four percent had a complete cytoreductive surgery through digestive (n = 7), spleen (n = 3), pancreas (n = 1) resections and/or multiple peritonectomies (n = 11). Five patients (20%) had intraperitoneal chemotherapy. Morbidity (Dindo-Clavien ≥3) was 12%. No postoperative death occurred. After a median follow-up of 42 months (range [2–194]), the median overall (OS) and progression-free (DFS) survival times were respectively 128 months and 31 months. Eighteen patients recurred (72%), mainly in the peritoneum (n = 16). Four of them (22%) were reoperated. The 5 and 10-year DFS rates were both 20.3%. The 5 and 10-year OS rates were 62% and 51.7%, respectively. A complete cytoreductive surgery was associated with a better OS and DFS in a univariate analysis.Conclusion: Complete cytoreductive surgery is the cornerstone of the PK's management as a primary treatment. Recurrence remains common and new adjuvant strategies seem needed.

Concerns are rising about the late adverse events following gastric bypass and sleeve gastrectomy. We aimed to assess, over a 7-year period, the late adverse events after gastric bypass and sleeve gastrectomy compared with matched control groups.In this nationwide, observational, population-based, cohort study, we used data extracted from the French National Health Insurance (Système National des Données de Santé) database. All patients undergoing gastric bypass or sleeve gastrectomy in France in 2009, except those who had undergone bariatric surgery in the previous 4 years before inclusion, were matched with control patients with obesity in terms of age, sex, BMI category, baseline antidiabetic therapy, and baseline insulin therapy. Exclusion criteria for the control group included cancer, pregnancy, chronic infectious disease, serious acute or chronic disease in 2008-09, or previous (2005-09) or forthcoming (2010-11) bariatric surgery. The incidence rate was calculated for each type of adverse event leading to inpatient hospital admission over a 7-year period; incidence rate ratios (with 95% CIs) were computed to compare the rate of complications among the bariatric surgery and control groups. Risks of complications during follow-up were compared using Cox proportional-hazards regression analyses. Data were analysed according to the intention-to-treat methodology.From Jan 1, 2009, to Dec 31, 2009, 8966 patients who underwent bariatric surgery (7359 [82%] women; mean age 40·4 years [SD 11·3]) and 8966 matched controls (7359 [82%] women; mean age 40·9 years [11·4]) were included in analyses 4955 (55%) off 8966 patients in the bariatric surgery group had a primary gastric bypass and 4011 (45%) patients had sleeve gastrectomy. With a mean follow-up of 6·8 years (SD 0·2), mortality was lower in the gastric bypass group than in its control group (hazard ratio 0·64 [95% CI 0·52-0·78]; p0·0001) and in the sleeve gastrectomy group than in its control group (0·38 [0·29-0·50]; p0·0001). The gastric bypass and sleeve gastrectomy groups had higher risk than did their control groups for invasive gastrointestinal surgery or endoscopy (incidence rate ratio 2·4 [95% CI 2·1-2·7], p0·0001, for gastric bypass vs control and 1·5 [1·3-1·7], p0·0001, for sleeve gastrectomy vs control); for gastrointestinal disorders not leading to invasive procedures (1·9 [1·7-2·1]), p0·0001, for gastric bypass vs control and 1·2 [1·1-1·4], p0·0001, for sleeve gastrectomy vs control); and for nutritional disorders (4·9 [3·8-6·4], p0·0001, for gastric bypass vs control and 1·8 [1·3-2·5], p0·0001, for sleeve gastrectomy vs control). For psychiatric disorders, there was no significant association (1·1 [0·9-1·4], p=0·190, for gastric bypass vs control and 1·1 [0·8-1·3], p=0·645, for sleeve gastrectomy vs control), except for gastric bypass and alcohol dependence (1·8 [1·1-2·8], p=0·0124).Despite lower 7-year mortality, patients undergoing gastric bypass or sleeve gastrectomy had higher risk of hospital admission at least once for late adverse events, except for psychiatric disorders, than did control patients, with a higher risk observed after gastric bypass than with sleeve gastrectomy.None.

PURPOSE Gastric cancer (GC) with peritoneal metastases (PMs) is a poor prognostic evolution. Cytoreductive surgery (CRS) yields promising results, but the impact of hyperthermic intraperitoneal chemotherapy (HIPEC) remains controversial. Here we aimed to compare outcomes between CRS-HIPEC versus CRS alone (CRSa) among patients with PMs from GC. PATIENTS AND METHODS From prospective databases, we identified 277 patients with PMs from GC who were treated with complete CRS with curative intent (no residual nodules > 2.5 mm) at 19 French centers from 1989 to 2014. Of these patients, 180 underwent CRS-HIPEC and 97 CRSa. Tumor burden was assessed using the peritoneal cancer index. A Cox proportional hazards regression model with inverse probability of treatment weighting (IPTW) based on propensity score was used to assess the effect of HIPEC and account for confounding factors. RESULTS After IPTW adjustment, the groups were similar, except that median peritoneal cancer index remained higher in the CRS-HIPEC group (6 v 2; P = .003). CRS-HIPEC improved overall survival (OS) in both crude and IPTW models. Upon IPTW analysis, in CRS-HIPEC and CRSa groups, median OS was 18.8 versus 12.1 months, 3- and 5-year OS rates were 26.21% and 19.87% versus 10.82% and 6.43% (adjusted hazard ratio, 0.60; 95% CI, 0.42 to 0.86; P = .005), and 3- and 5-year recurrence-free survival rates were 20.40% and 17.05% versus 5.87% and 3.76% ( P = .001), respectively; the groups did not differ regarding 90-day mortality (7.4% v 10.1%, respectively; P = .820) or major complication rate (53.7% v 55.3%, respectively; P = .496). CONCLUSION Compared with CRSa, CRS-HIPEC improved OS and recurrence-free survival, without additional morbidity or mortality. When complete CRS is possible, CRS-HIPEC may be considered a valuable therapy for strictly selected patients with limited PMs from GC.

Day-case surgery (DCS) in digestive surgery is a hot topic, and new indications for DCS in the field of gastrointestinal surgery have recently been described. Laparoscopic sleeve gastrectomy (LSG) has become a popular bariatric procedure in recent years. LSG is a reproducible, standardized procedure with a short operating time and possibly simple perioperative management. It therefore meets the criteria to be performed as a DCS procedure. Recently published series of LSG as DCS have demonstrated its feasibility. In this review on LSG performed as DCS, we focused on the management of risks associated with DCS and the results of such type of management. A literature search was conducted in the PubMed and Embase databases. Six studies were selected, comprising a total of 6227 patients. Most published series were retrospective single-center studies. Inclusion criteria were similar between most studies (primary sleeve gastrectomy for most series, patients with a body mass index ≥40 kg/m2 or a body mass index ≥35 kg/m2 in the presence of co-morbidities), while exclusion criteria were based on literature data for some studies (using series on risk factors for morbidity and mortality after Roux-en-Y gastric bypass) and personal experience for other series. The mortality rate of LSG as DCS ranges 0%–.08%, while the overall complication rate ranges 0%–10%. The unplanned overnight admission rate after LSG ranges .8%–8%. The unscheduled hospitalization rates range 2.1%–8.5%. LSG performed as DCS is feasible with good results, but cannot be proposed for all patients. Good selection is necessary in others to avoid increased risk of morbidity and mortality.

Obesity is a risk factor for chronic kidney disease (CKD) and a relative contraindication for renal transplantation. Bariatric surgery (BS) is an option to address this issue but we hypothesize that severe CKD is associated with a loss of efficacy of BS which could justify recommending it at an earlier stage of the CKD.A retrospective study (n = 101 patients) to test primarily for differences in weight loss at 6 and 12 months according to estimated glomerular filtration rate categories (eGFR 30 including patients on dialysis, 30-60, 60-90, and ≥ 90 ml/min/1.73 mIn the first comparison, the multivariate analysis showed a significant positive association between eGFR and weight loss. However, after exclusion of the subgroup of patients with eGFR 30 ml/min/1.73 mThe efficacy of BS was reduced in patients with advanced CKD. These results support early BS in patients with early-to-moderate CKD.