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To investigate the role of intraoperative estimated blood loss (EBL) on development of clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreatoduodenectomy (PD).Minimizing EBL has been shown to decrease transfusions and provide better perioperative outcomes in PD. EBL is also felt to be influential on CR-POPF development.This study consists of 5534 PDs from a 17-institution collaborative (2003-2018). EBL was progressively categorized (≤150mL; 151-400mL; 401-1,000 mL;1,000 mL). Impact of additive EBL was assessed using 20 3- factor fistula risk score (FRS) scenarios reflective of endogenous CR-POPF risk.CR-POPF developed in 13.6% of patients (N = 753) and median EBL was 400 mL (interquartile range 250-600 mL). CR-POPF and Grade C POPF were associated with elevated EBL (median 350 vs 400 mL, P = 0.002; 372 vs 500 mL, P0.001, respectively). Progressive EBL cohorts displayed incremental CR-POPF rates (8.5%, 13.4%, 15.2%, 16.9%; P0.001). EBL400mL was associated with increased CR-POPF occurrence in 13/20 endogenous risk scenarios. Moreover, 8 of 10 scenarios predicated on a soft gland demonstrated increased CR-POPF incidence. Hypothetical projections demonstrate significant reductions in CR-POPF can be obtained with 1-, 2-, and 3-point decreases in FRS points attributed to EBL risk (12.2%, 17.4%, and 20.0%; P0.001). This is especially pronounced in high-risk (FRS7-10) patients, who demonstrate up to a 31% reduction (P0.001). Surgeons in the lowest-quartile of median EBL demonstrated CR-POPF rates less than half those in the upper-quartile (7.9% vs 18.8%; P0.001).EBL independently contributes significant biological risk to CR-POPF. Substantial reductions in CR-POPF occurrence are projected and obtainable by minimizing EBL. Decreased individual surgeon EBL is associated with improvements in CR-POPF.

The objective of this study was to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications.The use of routine intraperitoneal drains during DP is controversial. Prior to this study, no prospective trial focusing on DP without intraperitoneal drainage has been reported.Patients undergoing DP for all causes at 14 high-volume pancreas centers were preoperatively randomized to placement of a drain or no drain. Complications and their severity were tracked for 60 days and mortality for 90 days. The study was powered to detect a 15% positive or negative difference in the rate of grade 2 or higher grade complications. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy.A total of 344 patients underwent DP with (N = 174) and without (N = 170) the use of intraperitoneal drainage. There were no differences between cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, or operative technique. There was no difference in the rate of grade 2 or higher grade complications (44% vs. 42%, P = 0.80). There was no difference in clinically relevant postoperative pancreatic fistula (18% vs 12%, P = 0.11) or mortality (0% vs 1%, P = 0.24). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (9% vs 22%, P = 0.0004). There was no difference in the frequency of postoperative imaging, percutaneous drain placement, reoperation, readmission, or quality of life scores.This prospective randomized multicenter trial provides evidence that clinical outcomes are comparable in DP with or without intraperitoneal drainage.

Background:Laparoscopic distal pancreatectomy (LDP) reduces postoperative morbidity, hospital stay, and recovery as compared with open distal pancreatectomy. Technical limitations of laparoscopic surgery may limit patient eligibility and require conversion to open or hand-assisted surgery to maintai

In breast cancer and other malignancies, involvement of regional lymph nodes is a strong prognostic indicator and greatly influences staging and clinical management.1–4 One benefit from the implementation of sentinel lymph node biopsy (SLNB) techniques is the identification of metastatic foci of cancer in 10% to 15% of patients that would have been previously staged as node-negative (pN0) by conventional methods.5,6 This improved sensitivity is attributed to both the addition of immunohistochemical staining (IHC) and to an increase in sampling volume.5,6 Many of these additional positive nodes contain only micrometastatic foci of tumor. However, the clinical significance of micrometastatic disease identified by SLNB techniques is highly controversial.7–11 Nonetheless, SLNB techniques are now widely used in breast cancer and melanoma and are being applied with increasing frequency to other tumors, including colorectal, oropharyngeal, prostate, lung, and other solid organ cancers.12–15 Another clear advantage to the SLNB technique is that in the majority of breast cancer patients, SLNB safely avoids axillary lymph node dissection (ALND) and the associated morbidity when the SLN is negative for metastatic disease.16 However, rapid, frozen-section analysis of SLN for metastasis is only 50% to 70% sensitive for the detection of metastasis compared with the permanent histologic sections and IHC of the same lymph node,17,18 and complete analysis of the SLNB specimen currently requires extensive preparation and time-consuming review.8 Even in experienced hands, 10% of SLNB specimens are later found to contain metastases.19 As a result, these patients have required a second surgical procedure to complete the ALND. This is clearly an undesirable algorithm for the patient, the healthcare provider, and the healthcare payer, and this dilemma has contributed to a new controversy; if the SLNB is positive, does a completion ALND confer a therapeutic or staging benefit to the patient? Until ongoing multicenter trials determine whether completing the ALND when the SLNB is positive for metastasis benefits the patient, it is clear that the time required to accurately evaluate SLNB specimens has significant implications.20 It must also be recognized that, even with adequate time, the accurate histologic analysis of lymph nodes for metastatic disease is challenging, and discordance in the interpretation of these materials is a well-known clinical problem. Indeed, a recent study found alarming disparity among pathologists in the analysis of SLNB specimens.21 Furthermore, protocols for SLNB specimen analysis vary widely between healthcare centers.22 Thus, current methods of lymph node analysis clearly lack standardization, are dependent in part on subjective criteria, and are subject to human error. We and others have shown that a real-time, quantitative RT-PCR (QRT-PCR) analysis of lymph nodes can be more accurate than conventional histologic analysis in predicting prognosis for solid organ malignancies,23,24 and we have previously reported our development of a rapid QRT-PCR procedure that can be completed (including RNA isolation) in less than 25 minutes.25 Importantly, a revolutionary tool for molecular-based assays called the GeneXpert (Cepheid, Sunnyvale, CA) is in the final stages of development. This instrument fully automates sample preparation, RNA isolation and purification, and QRT-PCR in a single-use, cartridge-based format that removes the major obstacles limiting routine use of molecular-based assays. Thus, we aimed to determine if a rapid, fully automated, internally controlled QRT-PCR assay performed by a prototype GeneXpert instrument could produce equivalent results to histologic techniques of SLNB analysis, including IHC. This assay could produce significant benefits to patients and healthcare providers by definitively analyzing lymph nodes using objective criteria in a time frame that allows intraoperative use, reduces patient psychologic distress, and improves standardization between healthcare centers.

Objective To test by randomized prospective multicenter trial the hypothesis that pancreaticoduodenectomy (PD) without the use of intraperitoneal drainage does not increase the frequency or severity of complications. Background Some surgeons have abandoned the use of drains placed during pancreas resection. Methods We randomized 137 patients to PD with (n = 68, drain group) and without (n = 69, no-drain group) the use of intraperitoneal drainage and compared the safety of this approach and spectrum of complications between the 2 groups. Results There were no differences between drain and no-drain cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, baseline quality of life, or operative technique. PD without intraperitoneal drainage was associated with an increase in the number of complications per patient [1 (0-2) vs 2 (1-4), P = 0.029]; an increase in the number of patients who had at least 1 ≥grade 2 complication [35 (52%) vs 47 (68%), P = 0.047]; and a higher average complication severity [2 (0-2) vs 2 (1-3), P = 0.027]. PD without intraperitoneal drainage was associated with a higher incidence of gastroparesis, intra-abdominal fluid collection, intra-abdominal abscess (10% vs 25%, P = 0.027), severe (≥grade 2) diarrhea, need for a postoperative percutaneous drain, and a prolonged length of stay. The Data Safety Monitoring Board stopped the study early because of an increase in mortality from 3% to 12% in the patients undergoing PD without intraperitoneal drainage. Conclusions This study provides level 1 data, suggesting that elimination of intraperitoneal drainage in all cases of PD increases the frequency and severity of complications.