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The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing.The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices.We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity.The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.

The concept that sphincter of Oddi dysfunction (SOD) can cause attacks of biliary-type pain in postcholecystectomy patients and those with unexplained recurrent acute pancreatitis, and that endoscopic sphincterotomy can ameliorate symptoms, remains unproven. The Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD) study of patients without objective evidence for biliary obstruction showed no difference in outcomes between those who underwent sphincterotomy or sham treatment.1 To date, there have been no studies examining the characteristics of patients who still are being offered endoscopic retrograde cholangiopancreatography (ERCP) for SOD since the EPISOD publication, although the absolute number appears to have declined.2.

Background and Objective: EUS-guided pancreatic drainage (EUS-PD) is an efficacious, acceptable risk option for patients with pancreatic duct obstruction who fail conventional ERCP. The aim of this study was to define the learning curve (LC) for EUS-PD. Methods: Consecutive patients undergoing EUS-PD by a single operator were included from a dedicated registry. Demographics, procedural info, adverse events, and follow-up data were collected. Nonlinear regression and cumulative sum (CUSUM) analyses were conducted for the LC. Results: Fifty-six patients were included (54% of male, with a mean age of 58 years). Technical success was achieved in 47 patients (84%). Stent placement was antegrade in 36 patients (77%) and retrograde in 11 (23%). Clinical success was achieved in 46/47 (98%) patients who achieved technical success. Adverse events were seen in 13 patients (6 of whom did not achieve technical success) and included bleeding requiring embolization (n = 5), bleeding treated with clips peri-procedurally (n = 1), pancreatitis (n = 5), and a pancreatic fluid collection drained via EUS-drainage (n = 2). The median procedural time was 80 min (range 49–159 min). The CUSUM chart showed that 80-min procedural time was achieved at the 27th procedure. Durations further reduced 40th procedure onward, reaching a plateau indicating proficiency (nonlinear regression P < 0.0001). Conclusion: Endoscopists experienced in EUS-PD are expected to achieve a reduction in procedural time over successive cases, with efficiency reached at 80 min and a learning rate of 27 cases. Continued improvement is demonstrated with additional experience, with plateau indicating mastery suggested at the 40th case. EUS-PD is probably one of the hardest therapeutic endosonographic procedures to learn.

INTRODUCTION Endoscopic ultrasound (EUS)-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) is a minimally invasive option for pancreaticobiliary access in patients with Roux-en-Y anatomy. The procedure involves creating a fistulous tract between the remnant stomach or jejunum and the bypassed stomach with the deployment of a lumen-apposing metal stent (LAMS), followed by the advancement of an endoscope through the LAMS to perform an ERCP or EUS. It is a technically challenging procedure, requiring skills in EUS, fluoroscopy, and LAMS deployment. The aim of this study was to determine the learning curve for EDGE. METHODS Consecutive patients undergoing EDGE by a single operator were included from a prospective registry over 3 years. Demographics, procedure info, postprocedure follow-up data, and adverse events were collected. Nonlinear regression and cumulative sum analyses were conducted for the learning curve. Technical success was defined as the successful creation of the fistulous tract. Clinical success was defined as successful EUS or ERCP via the LAMS. RESULTS Nineteen patients were included (21% male, mean age 58.7 y). Indication included symptomatic biliary stricture (n=6, 32%), choledocholithiasis (n=5, 26%), pancreatitis (n=3, 16%). Technical success was 100%. All patients had a 15 mm LAMS placed, 3 (16%) had cautery-enhanced LAMS. Clinical success was achieved in 18/19 (95%) patients. Fourteen patients had an ERCP, 1 patient had a EUS, and 3 patients had both. Adverse events included 2 cases of bleeding, 1 case of post-ERCP pancreatitis, and 1 jejunal perforation during duodenoscope insertion managed endoscopically.Median procedure time was 54.5 minutes (range: 31 to 88 min). Cumulative sum chart shows a 54-minute procedure time was achieved at the ninth procedure hence indicating efficiency. Apart from 2 outliers, the procedure duration further reduced with consequent procedures with the last 3 being under 40 minutes indicating that after 25 to 35 procedures a plateau may be reached indicating mastery (nonlinear regression P

Measures of health care use such as length of hospital stay (LOS) are used as proxies for quality of care after spine surgery. Accordingly, hospitals and health systems are investing considerable resources into the preoperative identification of patients at risk for prolonged LOS. This study aims to investigate the impact of preoperative level on outcomes and LOS after spinal fusion.The medical records of 204 elderly (≥60 years) male patients undergoing elective spinal fusion (≥3 levels) at a major academic institution from 2005 to 2015 were reviewed. The lower hemoglobin (Hgb) level was designated as13.5 g/dL. We identified 83 (40.7%) patients with preoperative lower Hgb levels and 121 (59.3%) with normal levels (low Hgb, n = 83; normal Hgb, n = 121). The primary outcomes investigated were complications and LOS.Demographics and comorbidities were similar between both groups, with mean Hgb levels being 12.3 ± 0.9 g/dL and 14.9 ± 1.0 g/dL for the low and normal cohorts, respectively. The lower Hgb cohort experienced higher rates of postoperative delirium (21.7% vs. 5.8%; P = 0.0007), non-wound infections (6.0% vs. 0.0%; P = 0.006), and hematoma formation (3.6% vs. 0.0%; P = 0.035). There was a significant difference in LOS between the cohorts, with the low Hgb cohort experiencing approximately a 2-fold increase (low Hgb, 8.1 ± 5.9 days vs. normal Hgb, 4.8 ± 2.5 days; P0.0001). Preoperative Hgb and hematocrit levels negatively correlated with LOS (Hgb, R = -0.388, P0.001 and Hct, R = -0.2883, P0.001).Our study shows that elderly male patients with lower preoperative Hgb levels have increased LOS and postoperative delirium after spinal fusion. Moreover, preoperative Hgb levels negatively correlate with LOS.

Introduction Lumen apposing metal stents (LAMS) have been used increasingly for drainage of pancreatic fluid collections (PFC). We present an international, multicenter study evaluating the safety and efficacy of LAMS in PFCs. Methods Consecutive patients undergoing LAMS placement for PFC at 12 international centers were included ( ClinicalTrials.gov NCT01522573). Demographics, clinical history, and procedural details were recorded. Technical success was defined as successful LAMS deployment. Clinical success was defined as PFC resolution at three-month follow-up. Results 192 patients were included (140 males (72.9%), mean-age 53.8 years), with mean follow-up of 4.2 months ± 3.8. Mean PFC size was 11.9 cm (range 2–25). The median number of endoscopic interventions was 2 (range 1–14). Etiologies for PFC were gallstone (n = 82, 42.7%), alcohol (n = 50, 26%), idiopathic (n = 26, 13.5%), and other (n = 34, 17.7%). Technical success was achieved in 189 patients (98.4%). Clinical success was observed in 125 of 135 patients (92.6%). Adverse events included bleeding (n = 11, 5.7), infection (n = 2, 1%), and perforation (n = 2, 1%). Three or more endoscopy sessions were a positive predictor for PFC resolution and the only significant predictor for AEs. Conclusion LAMS has a high technical and clinical success rate with a low rate of AEs. PFC drainage via LAMS provides a minimally invasive, safe, and efficacious procedure for PFC resolution.

Cholangiocarcinoma, a malignancy of the epithelial cells in the intrahepatic or extrahepatic biliary tree, is often diagnosed at later stages. Median survival duration ranges from 3 to 9 months with a less than ten percent 5-year survival rate. Thus, often treatment strategies are aimed more towards palliation instead of cure. With the majority of patients presenting with unresectable disease at the time of diagnosis, surgical intervention is not feasible, making less invasive endoscopic therapies more suitable. Initially, biliary stents were utilized for biliary decompression to mitigate cholestatic symptoms and prevent cholangitis; however, this strategy did not prove to provide significant survival benefit. Therefore, efforts to treat the tumor burden itself in addition to maintaining biliary patency became a focus of innovation and research in the endoscopic field. This study has led to the advent of therapies such as photodynamic therapy, radiofrequency ablation, and intraluminal brachytherapy. These options combined with biliary stenting have shown to not only offer the benefit of biliary decompression, but also to potentially improve stent patency and survival. Further, there is an anti-tumor effect of each of these modalities, portending an additional benefit in this subset of patients. Despite numerous retrospective and prospective studies assessing these ablative therapies, there is still a paucity of appropriately powered randomized controlled trials, and further research has yet to be done in the field. This review details the current literature entailing endobiliary ablative strategies.

Background The aim of this study was to assess whether the Koenig Depression Scale (KDS) can identify depressed elderly patients undergoing elective spine surgery for deformity at risk for inferior postoperative outcomes including complication rates, ambulation ability, and patient-reported outcomes. Methods The medical records of 92 elderly patients (≥65 years) undergoing a planned elective spinal surgery for correction of adult degenerative scoliosis were reviewed for this study. Preoperative baseline depression was assessed using the validated KDS that was administered by a board-certified geriatrician. KDS is made up of 11 questions with a maximum of 11 points (No-Depression = KDS Results Of the 92 patients, 20 of them (21.7%) were found to have a KDS ≥4. Baseline demographics and comorbidities were similar between both cohorts. Intraoperative variables and complications were similar between both cohorts. There were no significant differences in postoperative complications including length of hospital stay. There was no significant difference in ambulation abilities including preoperative gait speed (P = 0.38), days from operation to ambulation (P = 0.86), steps on first day of ambulation (P = 0.57), and steps before hospital discharge (P = 0.35). There was no significant difference between the cohorts in VAS scores at baseline (P = 0.19), 6 weeks (P = 0.91), 3 months (P = 0.58), and 6 months (P = 0.97) after hospital discharge. Conclusions Our study found no difference in complication rates, ambulation abilities, and follow-up VAS scores between patients with and without depression using preoperative KDS.

Contains fulltext : 215317.pdf (Publisher’s version ) (Closed access) OBJECTIVES: In patients with acute recurrent pancreatitis (ARP), pancreas divisum, and no other etiologic factors, endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) is often performed to enlarge the minor papillary orifice, based on limited data. The aims of this study are to describe the rationale and methodology of a sham-controlled clinical trial designed to test the hypothesis that miES reduces the risk of acute pancreatitis. METHODS: The SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial is a multicenter, international, sham-controlled, randomized trial comparing endoscopic ultrasound + ERCP with miES versus endoscopic ultrasound + sham for the management of ARP. A total of 234 consented patients having 2 or more discrete episodes of acute pancreatitis, pancreas divisum confirmed by magnetic resonance cholangiopancreatography, and no other clear etiology for acute pancreatitis will be randomized. Both cohorts will be followed for a minimum of 6 months and a maximum of 48 months. RESULTS: The trial is powered to detect a 33% risk reduction of acute pancreatitis frequency. CONCLUSIONS: The SHARP trial will determine whether ERCP with miES benefits patients with idiopathic ARP and pancreas divisum. Trial planning has informed the importance of blinded outcome assessors and long-term follow-up.

Choledocholithiasis is a common disorder that is managed universally by endoscopic retrograde cholangiopancreatography (ERCP). For difficult or complex stones, ERCP with conventional techniques may fail to achieve biliary clearance in 10% to 15% of cases. This review summarizes the literature regarding the current available endoscopic techniques for complex stone disease, including mechanical lithotripsy, endoscopic papillary large balloon dilation, cholangioscopy-guided lithotripsy, and endoscopic ultrasound-guided biliary access.

Background and Aim: Pancreatic plastic stents (PPS) can reduce the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). Prospective multicenter documentation of PEP rate after PPS placement is scarce. A new 4-Fr stent designed to be deployed over a 0.035-inch guidewire was used to assess the effectiveness of PEP prophylaxis. Methods: High-PEP-risk patients received a 4-Fr PPS for primary or secondary prophylaxis at seven centers in four countries. Patients were followed until spontaneous PPS migration, endoscopic stent removal, or for 4 months, whichever came first. Main outcome was PEP rate. Results: One hundred six (106) patients received PPS for PEP prophylaxis [61 (58%) primary, 45 (42%) secondary prophylaxis]. Median age was 54 years. Eighty-one (76%) PPS were placed using a 0.035-inch guidewire. By investigator choice 99 (93%) stents were single pigtail. Median stent length was 8 cm (range 3–12 cm). Technical success achieved in 100% of cases. Two patients in the primary prophylaxis group (3%, 95% CI 0.4–11%) experienced mild/moderate PEP. Seventy-eight PPS available for analysis underwent spontaneous migration after a median of 29 days. There were no reports of stent-induced ductal trauma. Post-hoc analysis of migration rate by PPS length showed no statistically significant trend. Conclusions: Among high-risk patients in the primary prophylaxis group, observed rates of PEP are low (3%, 95% CI 0.4– 11%) with the use of prophylactic 4-Fr pancreatic duct stents compatible with a 0.035-inch guidewire. This low rate is not unequivocally due to the prophylactic stent.

In Uganda, TBI constitute the majority of neurosurgical admissions and deaths specially in the pediatric population. This study aims to determine the factors associated with poor outcome among pediatric TBI cases at a major referral hospital in western Uganda.This study was conducted at Mbarara Regional Referral Hospital (MRRH) in western Uganda. All pediatric neurosurgical cases between 2012 and 2015 were reviewed. In-hospital mortality and discharge GCS were the main outcomes of interest. Multivariable logistic regression with backward elimination was used to determine the factors significantly associated with outcome.A total of 381 pediatric TBI patients were admitted to MRRH between 2012 and 2015. The mean age was 8.6 (SD 5.6) with a male predominance (62.0%). The most common mechanism of injury overall was RTI, which was responsible for 71% of all TBI cases. In the multivariable logistic regression model, admission GCS 13 was a strong predictor of poor outcome and in-hospital mortality compared to admission GCS ≥ 13, with patients demonstrating an odds ratio of 30 (95%CI: 7-132) and OR of 18 (95%CI: 4-79), respectively.Given the lack of published literature on pediatric TBI in LMICs, this study was the first to describe and evaluate risk factors associated with TBI severity among pediatric patients at a major referral hospital in western Uganda. Injury severity on admission was the only variable found to be significantly associated with discharge outcome. This study ultimately highlights the need for more effective preventative measures to decrease admission severity.

Background and Aims The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases, yet standard ERCP is not possible because of surgically altered gastroduodenal anatomy. Laparoscopy-assisted ERCP (LA-ERCP) has been proposed as an option, but supporting data are derived from single-center small case series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP. Methods This is a retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all the following were achieved: reaching the papilla, cannulating the desired duct, and providing endoscopic therapy as clinically indicated. Results A total of 579 patients (median age, 51; 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (interquartile range [IQR], 109-210), with a median ERCP time of 40 minutes (IQR, 28-56). Median hospital stay was 2 days (IQR, 1-3). Adverse events were 18% (laparoscopy related, 10%; ERCP related, 7%; both, 1%) with the clear majority (92%) classified as mild/moderate, whereas 8% were severe and 1 death occurred. Conclusions Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. The ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher because of the added laparoscopy-related events.

Background and Objective: EUS-guided-biliary drainage (EUS-BD) is an efficacious and safe option for patients who fail ERCP. EUS-BD is a technically challenging procedure. The aim of this study was to define the learning curve for EUS-BD. Methods: Consecutive patients undergoing EUS-BD by a single operator were included for a prospective registry over 6 years. Demographics, procedural information, adverse events, and follow-up data were collected. Nonlinear regression and CUSUM analyses were conducted for the learning curve. Technical success was defined as successful stent placement. Clinical success was defined as resolution of jaundice and/or at least a 30% reduction in the pretreatment bilirubin level within a week after placement or normalization of bilirubin within 30 days. Results: Seventy-two patients were included in the study (53% male, mean age 67 years). Technical success was achieved in 69 patients (96%). Clinical success was achieved in 59/69 patients (86%). Seven patients (10%) had adverse events including bleeding (n = 6) and liver abscess (n = 1). The median procedural time was 59 min (range 36–138 min). This was achieved at the 32nd procedure. Procedural durations were further reduced to 50 min and below after the 50th procedure in a nonlinear pattern. This suggests that procedural durations approach a potential plateau after 100 cases. Conclusion: Endoscopists experienced in EUS-BD are expected to achieve a reduction in procedural time over successive cases, with efficiency reached at 59 min and a learning rate of 32 cases. Continued improvement is demonstrated with additional experience, with mastery suggested after approximately 100 cases.

Post-cholecystectomy syndrome and the concept of a causal relationship to sphincter of Oddi dysfunction, despite the controversy, has presented a clinically relevant conflict for decades. Historically surgeons, and now gastroenterologists have expended tremendous efforts towards trying to better understand the dilemma that is confounded by unique patient phenotypes. Areas covered: This review encompasses the literature from a century of experience on the topic of post-cholecystectomy syndrome. Relevant historical and anecdotal experiences are examined in the setting of insights from evaluation of recently available controlled data. Expert commentary: Historical observations and recent data suggest that patients with post-cholecystectomy syndrome can be categorized as follows. Patients with sphincter of Oddi stenosis will most often benefit from treatment with sphincterotomy. Patients with classic biliary pain and some objective evidence of biliary obstruction may have a sphincter of Oddi disorder and should be considered for endoscopic evaluation and therapy. Patients with atypical post-cholecystectomy pain, without any evidence consistent with biliary obstruction, and/or with evidence for another diagnosis or dysfunction should not undergo ERCP.

Background Fully covered self-expandable metal stents (FCSEMSs) have been used for palliation of both malignant and benign biliary strictures. Limited data are available about safety and outcome of endoscopic removal of these stents. Objective To evaluate safety and efficacy of endoscopic removal of FCSEMSs. Design Retrospective review of patients who underwent endoscopic removal of Viabil FCSEMSs. Setting Four centers with experience in using FCSEMSs. Patients Thirty-seven patients who had stents endoscopically removed. Intervention ERCP with endoscopic removal of FCSEMSs. Main Outcome Measurements Feasibility, safety, and complications associated with endoscopic removal of FCSEMS. Results All 37 stent removal attempts were successful and were achieved without difficulty. Indwelling stent-related complications occurred in 4 of 37 patients, including secondary strictures in 3 and minor bile leak in 1. Two of 3 secondary strictures occurred at the distal stent margin of oversized intraductal stents, and another stricture occurred at a proximal stent margin of an oversized transpapillary stent. One case of minor confined intratumoral bile leak also occurred in a patient with metastatic urothelial cancer of the bile duct. All of these cases were successfully treated with repeat stenting and resolved without sequelae. No free perforations or significant bleeding occurred. Limitations Retrospective study. Conclusion Endoscopic removal of Viabil FCSEMSs placed for benign or malignant conditions is feasible and easily accomplished. Secondary strictures may be found at the time of stent removal or with a delayed presentation in patients with oversized stents who may require repeat stent placement.

Background Working parties of the American Society for Gastrointestinal Endoscopy (ASGE) Quality Committee recently published a proposed new lexicon for adverse events and a separate extensive review of risk factors. The complexity of procedures also affects outcomes. Objective To establish a system for grading the complexity of endoscopic procedures. Design Voting on levels 1 (easiest) to 4 (most difficult) on a list of possible procedures and contexts. Setting Community and academic gastroenterologists in the United States, Canada, and Britain. Main Outcome Measurements Median scores of votes cast. Results Consensus list of levels 1 through 4 contexts and procedures. Limitations Eminence rather than evidence based. Conclusions A consensus list was developed for comments and testing to complement the proposed lexicons for adverse events and risk factors.

Background & Aims Prophylactic placement of pancreatic duct (PD) stents reduces the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) in high-risk patients. Some endoscopists prefer longer length, unflanged 3Fr PD stents because they are supposedly more effective and have a higher rate of spontaneous dislodgement; we compared outcomes of patients with these 2 types of stents. Methods Patients at high risk for PEP were randomly assigned to groups given either a straight, 5Fr, 3 cm long, unflanged PD stent (n = 116) or a 3Fr, 8 cm or longer, unflanged PD stent (n = 133). Abdominal radiographs were obtained at 24 hours, 7 days, and 14 days following stent placement to assess spontaneous stent dislodgement. PEP was defined according to consensus criteria. Results After 14 days, the spontaneous stent dislodgement rates were 98% for 5Fr stents and 88% for 3Fr stents (P = .0001). PEP occurred in 12% of patients. The incidence of PEP was higher in the 3Fr group (14%) than the 5Fr group (9%), although this difference was not statistically significant (P = .3). Placement failure did not occur in any patients in the 5Fr stent group, but did occur in 11 of the 133 patients in the 3Fr stent group (P = .0003). Conclusions Among patients at high-risk for PEP, the spontaneous dislodgement rate of unflanged, short-length, 5Fr PD stents is significantly higher than for unflanged, long-length, 3Fr stents. This decreases the need for endoscopic removal. A higher rate of PD stent placement failure and PEP was observed in patients with 3Fr stents. To view this article's video abstract, go to the AGA's YouTube Channel.

Background Symptomatic choledocholithiasis during pregnancy can be treated with ERCP, but fluoroscopy may pose a risk to the fetus. Nonradiation ERCP may be a safer form of treatment, but its performance has not been optimized. Objectives The purpose of this study was to evaluate new methods of nonradiation ERCP during pregnancy, including wire-guided cannulation techniques to achieve bile-duct access without the use of fluoroscopy, and the use of peroral choledochoscopy to confirm ductal clearance. Study Design A retrospective review of consecutive ERCPs performed on pregnant women. Setting Urban referral hospital. Patients Pregnant women with symptomatic choledocholithiasis. Interventions All patients underwent therapeutic ERCP without any use of fluoroscopy. Endoscopist-controlled wire-guided cannulation was performed to achieve biliary access. Main Outcome Measurements The rate of successful biliary cannulation and short-term outcomes. Limitations ERCP procedures were performed by a single endoscopist. Results Successful bile-duct cannulation with sphincterotomy and the removal of biliary stones or sludge was performed without fluoroscopy in 21 pregnant women. There was one case of mild post-ERCP pancreatitis. Choledochoscopy confirmed ductal clearance in 5 cases. Conclusions Nonradiation ERCP is a safe and effective treatment for symptomatic choledocholithiasis during pregnancy. Wire-guided biliary cannulation and choledochoscopy may enhance the performance of ERCP in this setting.

We hypothesized that early intervention in patients with lower gastrointestinal bleeding (LGIB) would improve outcomes and therefore conducted a prospective randomized study comparing urgent colonoscopy to standard care.Consecutive patients presenting with LGIB without upper or anorectal bleeding sources were randomized to urgent purge preparation followed immediately by colonoscopy or a standard care algorithm based on angiographic intervention and expectant colonoscopy.A total of 50 patients were randomized to each group. A definite source of bleeding was found more often in urgent colonoscopy patients (diverticula, 13; angioectasia, 4; colitis, 4) than in the standard care group (diverticula, 8; colitis, 3) (the odds ratio for the difference among the groups was 2.6; 95% CI 1.1-6.2). In the urgent colonoscopy group, 17 patients received endoscopic therapy; in the standard care group, 10 patients had angiographic hemostasis. There was no difference in outcomes among the two groups-including: mortality 2%versus 4%, hospital stay 5.8 versus 6.6 days, ICU stay 1.8 versus 2.4 days, transfusion requirements 4.2 versus 5 units, early rebleeding 22%versus 30%, surgery 14%versus 12%, or late rebleeding 16%versus 14% (mean follow-up of 62 and 58 months).Although urgent colonoscopy identified a definite source of LGIB more often than a standard care algorithm based on angiography and expectant colonoscopy, the approaches are not significantly different with regard to important outcomes. Thus, decisions concerning care for patients with acute LGIB should be based on individual experience and local expertise.

Ability to achieve duct access is a prerequisite since ERCP is now mostly performed with therapeutic intent. ERCP outcomes are linked to the success and safety of cannulation. Evaluation of an ERCP technique is complex because of integrally related factors including device properties, variable methods, patient characteristics, and endoscopist preferences and expertise. Remarkably, there has been little progress regarding primary cannulation techniques since the first contrast injection nearly 40 years ago. ERCP guidewires were initially designed and utilized in order to maintain ductal access during therapeutic maneuvers. Guidewires are now increasingly being used to achieve duct cannulation despite a paucity of data to support this practice. Are we heading in the right direction, or is wire-guided cannulation a misguided adventure?

Background: Clinical evaluation of intraoperative endoscopy with electrohydraulic lithotripsy (EHL) in the management of 13 patients with pancreatobiliary lithiasis was undertaken. Methods: Ten patients with chronic pancreatitis with intraductal lithiasis in the head and three with biliary lithiasis (one choledochal, one cystic, one right intrahepatic) underwent intraoperative endoscopy with EHL. Shock waves were applied by visual contact with a 3-Fr gauge EHL probe until all stones were fragmented and irrigated free. All pancreatitis patients had failed ERCP attempts to stent their pancreatic ducts secondary to ductal lithiasis. Patients with pancreatic stones underwent lateral pancreatojejunostomy. Biliary stone patients underwent laparoscopic cholecystectomy with common duct exploration (two cases) and open cholecystectomy with choledochoduodenostomy (one case). Results: Intraductal stone eradication was successful in all patients. Transampullary visualization of the duodenum was achieved in eight cases. Average EHL time was 65 min. There was no evidence of postoperative pancreatitis, cholangitis, or retained common duct stones. Conclusion: Intraoperative pancreatobiliary endoscopy with EHL is safe and effective in the eradication of pancreatic and bile duct stones. This novel technique represents a valuable adjunct in the management of chronic fibrocalcific pancreatitis with ductal lithiasis in the head region and in the open and laparoscopic management of intra- and extrahepatic bile duct stones.

Abdominal pain after cholecystectomy is common and may be attributed to sphincter of Oddi dysfunction. Management often involves endoscopic retrograde cholangiopancreatography (ERCP) with manometry and sphincterotomy.To determine whether endoscopic sphincterotomy reduces pain and whether sphincter manometric pressure is predictive of pain relief.Multicenter, sham-controlled, randomized trial involving 214 patients with pain after cholecystectomy without significant abnormalities on imaging or laboratory studies, and no prior sphincter treatment or pancreatitis randomly assigned (August 6, 2008-March 23, 2012) to undergo sphincterotomy or sham therapy at 7 referral medical centers. One-year follow-up was blinded. The final follow-up visit was March 21, 2013.After ERCP, patients were randomized 2:1 to sphincterotomy (n = 141) or sham (n = 73) irrespective of manometry findings. Those randomized to sphincterotomy with elevated pancreatic sphincter pressures were randomized again (1:1) to biliary or to both biliary and pancreatic sphincterotomies. Seventy-two were entered into an observational study with conventional ERCP managemeny.Success of treatment was defined as less than 6 days of disability due to pain in the prior 90 days both at months 9 and 12 after randomization, with no narcotic use and no further sphincter intervention.Twenty-seven patients (37%; 95% CI, 25.9%-48.1%) in the sham treatment group vs 32 (23%; 95% CI, 15.8%-29.6%) in the sphincterotomy group experienced successful treatment (adjusted risk difference, -15.6%; 95% CI, -28.0% to -3.3%; P = .01). Of the patients with pancreatic sphincter hypertension, 14 (30%; 95% CI, 16.7%-42.9%) who underwent dual sphincterotomy and 10 (20%; 95% CI, 8.7%-30.5%) who underwent biliary sphincterotomy alone experienced successful treatment. Thirty-seven treated patients (26%; 95% CI,19%-34%) and 25 patients (34%; 95% CI, 23%-45%) in the sham group underwent repeat ERCP interventions (P = .22). Manometry results were not associated with the outcome. No clinical subgroups appeared to benefit from sphincterotomy more than others. Pancreatitis occurred in 15 patients (11%) after primary sphincterotomies and in 11 patients (15%) in the sham group. Of the nonrandomized patients in the observational study group, 5 (24%; 95% CI, 6%-42%) who underwent biliary sphincterotomy, 12 (31%; 95% CI, 16%-45%) who underwent dual sphincterotomy, and 2 (17%; 95% CI, 0%-38%) who did not undergo sphincterotomy had successful treatment.In patients with abdominal pain after cholecystectomy undergoing ERCP with manometry, sphincterotomy vs sham did not reduce disability due to pain. These findings do not support ERCP and sphincterotomy for these patients.clinicaltrials.gov Identifier: NCT00688662.

Magnetic resonance cholangiopancreatography (MRCP) is a new noninvasive diagnostic method for pancreaticobiliary (PB) imaging without endoscopy, sedation, or iodinated contrast. The purpose of this study was to evaluate the ability of MRCP to depict pancreatic and biliary ductal anatomy compared to that of endoscopic retrograde cholangiopancreatography (ERCP) and to evaluate the ability of MRCP to accurately diagnose PB neoplasms.Twenty patients had MRCP, and 17 also had ERCP. All studies were read prospectively by experienced reviewers blinded to other imaging data. Pathologic diagnosis was made in all patients.Bile duct dilatation seen by ERCP in 14 of 17 patients was correctly identified by MRCP in all 14 patients, and normal ducts were correctly identified by MRCP in the other 3 patients. The pancreatic duct was visible on MRCP in the pancreatic head in 17 of 20 patients, the body in 17 of 20 patients, and the tail in 15 of 20 patients. At ERCP, pancreatic duct dilatation was present in 11 cases and was identified by MRCP in 10 of them. Eighteen of 20 patients had malignant PB neoplasms. MRCP indicated PB neoplasm in 19 patients. Seventeen of these 19 patients had histologically confirmed malignant neoplasms pathologically, whereas 2 had benign pathology (both chronic pancreatitis). Among the 17 patients who also had ERCP, MRCP and ERCP correctly agreed on a final diagnosis of malignant neoplasm in 14 cases. In the three cases in which MRCP and ERCP disagreed on a final diagnosis, MRCP was correct in one and incorrect in two.MRCP can accurately and noninvasively delineate PB ductal anatomy and diagnose PB neoplasms comparably to ERCP. MRCP is an interesting new noninvasive method for evaluating patients with suspected PB neoplasms.

the management of Mirizzi's syndrome. Endoscopy 1988;20: 321-2. 6. Binmoeller KF, Thonke F, Soehendra N. Endoscopic treatment of Mirizzi's syndrome. Gastrointest Endosc 1993;39: 532-6. 7. Kodali VP, Petersen BT. Endoscopic therapy of postcholecystectomy Mirizzi syndrome. Gastrointest Endosc 1996;44:8690. 8. Baron TH, Schroeder PL, Schwartzberg MS, Carabasi MH. Resolution of Mirizzi's syndrome using endoscopic therapy. Gastrointest Endosc 1996;44:343-5. 9. Riemann JF, Seubert K, Demling L. Clinical application of a new mechanical lithotriptor for smashing common bile duct stones. Endoscopy 1982;14:226-30. 10. Darzi A, Leahy A, O'Morain C, Tanner WA, Keane FBV. Gallstone clearance: a randomized study of extracorporeal shock wave lithotripsy and chemical dissolution. Br J Surg 1990;77:1265-7. 11. Koch H, Stolte M, Walz V. Endoscopic litbotripsy in the common bile duct. Endoscopy 1977;9:95-8. 12. Lux G, Ell C, Hochberger J. The first successful endoscopic retrograde laser lithotripsy of common bile duct stones in man using a pulsed neodymium-YAG laser. Endoscopy 1986; 18:144-5. 13. Me L, Hwang M, Yueh S. Percutaneous transhepatic choledochoscopic electrohydraulic lithotripsy (PTCS-EHL) of common bile duct stones. Gastrointest Endosc 1988;34:122-5. 14. Sauerbruch T, Delius M, Paumgartner G, Fragmentation of gallstones by extracorporeal shock waves. N Engl J Med 1986;314:818-22. 15. Sauerbruch T, Stern M, the Study Group for Shock-wave Lithotripsy of Bile Duct Stones. Fragmentation of bile duct stones by extracorporeal shock waves: a new approach to biliary calculi after failure of routine endoscopic measures. Gastroenterology 1989;96:146-52. 16. Moody FG, Amerson JR, Berci G. Lithotripsy for bile duct stones. Am J Surg 1989;158:241-7. 17. Sauerbruch T, Hell J, Sackmann M, Paumgartner G. Fragmentation of bile duct stones by extracorporeal shock-wave lithotripsy: a five-year experience. Hepatology 1992;15:208-14.

A multidisciplinary approach using traditional open surgery, endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic surgery has revolutionized the care of the adult with pancreaticobiliary disease. This study focuses on a similar collaborative effort to diagnose and treat children with pancreaticobiliary disorders. Charts of all patients treated on the pediatric surgery service between June 1990 and May 1995, who also underwent ERCP, were abstracted for disease process, presenting symptoms, laboratory evaluation, surgical or endoscopic procedures, and eventual outcome. Twenty-six children were identified, ranging from 6 months to 19 years of age. Pancreaticobiliary disorders included pancreas divisum (n = 1), choledochal cyst (n = 4), pancreaticobiliary trauma (n = 4), cholelithiasis and choledocholithiasis (n = 17). The pancreaticobiliary tree was successfully visualized by ERCP in 25 of 26 (96%) patients. Fifteen of these patients also underwent attempted therapeutic endoscopic procedures, with 13 (87%) performed successfully. Three patients with choledochal cyst had stents placed preoperatively for cholangitis, all of whom have undergone successful choledochal cyst excision. Two trauma patients underwent attempted stenting of a bile leak and bile duct stricture, respectively, both of which were unsuccessful, necessitating surgical correction. Seventeen patients with cholelithiasis underwent ERCP to rule out choledocholithiasis. Ten patients were found to have common duct stones, and all stones were endoscopically extracted, including those in a 6-month-old child. Overall survival rate was 96% (25 of 26), with the one death occurring in a trauma patient unrelated to his pancreaticobiliary disorder. A multidisciplinary approach using traditional open surgery, ERCP and laparoscopic surgery can successfully treat even young children with pancreaticobiliary disorders. In experienced hands, diagnostic ERCP and therapeutic endoscopic intervention can be performed successfully in most pediatric patients, greatly simplifying the surgical management of these potentially complex problems.

The evaluation and management of patients with pancreaticobiliary pain and suspected sphincter of Oddi dysfunction (SOD) is quite challenging. The process begins with a careful history. The hallmark symptom is pain, and a careful characterization of timing, location, and precipitating and relieving factors will go a long way to ruling in or excluding the diagnosis. We still believe the Geenen-Hogan classification can be helpful to clinicians in evaluating patients. If the history is consistent with SOD, one should obtain measurements of bile duct and pancreatic duct diameter. Finally, liver tests, amylase, and lipase should be drawn during an episode of pain. These data will allow a general categorization of these patients into type I, II or III. Patients with a good history of biliary colic with gallbladder in situ should undergo laparoscopic cholecystectomy. Medical management for SOD should be the treatment of choice for type III patients. Type I patients should undergo biliary sphincterotomy. Based on existing randomized trials, type II patients should undergo SOM with biliary sphincterotomy if the sphincter of Oddi manometry is positive. In this clinical setting, ERCP should be performed only by individuals with extensive experience and advanced skills in pancreatic stenting. Optimal care of these patients requires an astute and caring physician combined with advanced ERCP skills in appropriate patients.

Background: Proximal migration of a biliary stent is an uncommon event, but its management can present a technical challenge to the therapeutic endoscopist. Methods: We reviewed the methods that have been used for retrieval of proximally migrated biliary stents in a referral endoscopy center. Results: Forty-four cases were identified; 38 stents (86%) were extracted successfully. Half of the stents were retrieved after first passing a guide wire through the stent lumen. Various accessories were then used to withdraw the stents, the Soehendra device being the most popular. Nearly one third were retrieved by grasping the stents directly, usually with a wire basket or forceps. The remainder were recovered after using a stone retrieval balloon alongside the stents to provide traction indirectly. Interventional radiology techniques were needed in two cases, and surgery in one. Conclusions: Cannulating the stent lumen with a wire is often the best approach in patients with a biliary stricture or a nondilated duct. An over-the-wire accessory can then be used to secure the stent. In patients with a dilated duct, indirect traction with a balloon or direct grasping of the stent with a wire basket, snare, or forceps is usually successful. Using these techniques, most proximally migrated biliary stents can be retrieved endoscopically. (Gastrointest Endosc 1995;42:513-9.)

Objective This endoscopic retrograde cholangiopancreatography-(ERCP)based study estimates the potential role of laparoscopic cholecystojejunostomy for palliation of patients with malignant obstructive jaundice. Summary background data Traditional treatment of malignant obstructive jaundice has used a standard bilioenteric anastomosis. Laparoscopic biliary bypass via a gallbladder conduit currently is an established technique; it provides a low initial morbidity alternative to open procedures, similar to endoscopic stenting. No study has specifically addressed anatomic factors relevant to cholecystojejunostomy, such as prior cholecystectomy, stricture location in reference to the hepatocystic junction, and cystic duct patency in patients with malignant obstructive jaundice. Methods Retrograde cholangiograms were reviewed from consecutive patients with malignant obstructive jaundice and a control group without biliary disease who underwent ERCP during a 2-year period. Patients with either prior biliary surgery or hilar tumors were excluded. The presence of gallbladder or cystic duct filling was assessed. In patients with patent cystic ducts, the distance from obstruction to the cystic duct takeoff was classified as either greater or less than 1 cm. Results Nearly half the patients with malignant obstructive jaundice were ineligible for cholecystojejunostomies because of prior biliary surgery (29%) or hilar tumors (17%). Half (50 of 101) of the remaining potential candidates had patent hepatocystic junctions. Patients with ampullary carcinoma and patent hepatocystic junctions (5 of 9) were all ideal candidates for cholecystojejunostomies, having biliary obstruction more than 1 cm from the cystic duct takeoff. Two thirds of the remaining eligible patients (28 of 45) had obstructions less than 1 cm from patent hepatocystic junctions. Conclusions Palliation of malignant obstructive jaundice by laparoscopic cholecystojejunostomy should only be attempted after direct cholangiography demonstrates a patent hepatocystic junction that is well separated from the malignant stricture. The majority of patients with malignant obstructive jaundice are ineligible for cholecystojejunostomies because of prior cholecystectomies, hilar obstructions, or tumor involvement of the hepatocystic junction. Nonoperative treatments will continue to be indicated for the majority of patients with malignant obstructive jaundice.

Importance Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution. Objective To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution. Design, Setting, and Participants Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded. Interventions Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence. Main Outcomes and Measures Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of −15%. Results There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, −3.0% to ∞; P P Conclusions and Relevance Among patients with benign biliary strictures and a bile duct diameter 6 mm or more in whom the covered metallic stent would not overlap the cystic duct, cSEMS were not inferior to multiple plastic stents after 12 months in achieving stricture resolution. Metallic stents should be considered an appropriate option in patients such as these. Trial Registration clinicaltrials.gov Identifier:NCT01221311

Techniques for bile duct stone extraction after sphincter dilation are described in this article. Available data regarding stone removal after papillary balloon dilation and the settings in which stone extraction without sphincterotomy should be considered are reviewed.

Background Reduced resident work hours over the last several years have led to inadequate exposure to hepatopancreaticobiliary (HPB) and complex upper gastrointestinal (UGI) surgical procedures. Therefore, residents are seeking additional training in this field. The purpose of this study is to determine the role of a new fellowship model in the training of general surgery residents in complex HPB/UGI diseases. Methods We propose a surgical training model in benign as well as malignant diseases of the UGI tract. The proposed model would focus on an integrated approach that involves allied specialties such as gastroenterology (GI) and radiology. Results The fellowship was set as 1-year duration with 1-month rotations on interventional GI and transplantation. The fellow spent the remaining 10 months on a UGI laparoscopic and open surgery service caring for complex benign and malignant disease of the esophagus, stomach, bile duct, pancreas, and liver. Didactic conferences were focused specifically at an organ-based approach to diseases of these organs. During a 12-month fellowship, exposure to complex diseases of the UGI tract was accomplished without negatively impacting the general surgery residency program. Conclusion This new mode of advanced training provides a bridge between surgical oncology and transplantation, and it is an excellent model for postgraduate surgical training in UGI diseases.