Paul R. Tarnasky

Urgent Colonoscopy for Evaluation and Management of Acute Lower Gastrointestinal Hemorrhage: A Randomized Controlled Trial

OBJECTIVES: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.METHODS: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.RESULTS: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).CONCLUSION: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.

Grading the complexity of endoscopic procedures: results of an ASGE working party

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.

Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial.

IMPORTANCE 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. OBJECTIVE To determine whether endoscopic sphincterotomy reduces pain and whether sphincter manometric pressure is predictive of pain relief. DESIGN, SETTING, AND PATIENTS 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. INTERVENTIONS 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. MAIN OUTCOMES AND MEASURES 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. RESULTS 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. CONCLUSIONS AND RELEVANCE 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. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00688662.

Therapeutic ERCP in the management of pancreatitis in children

BACKGROUND The use of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP) is increasing in the management of pancreatobiliary diseases in children. METHODS Over a 32-month period, we performed 34 ERCP procedures for the treatment of pancreatitis in 22 children at two university hospitals. Demographics and clinical data and ERCP findings were documented. Clinical status was assessed 6 months before the first ERCP and 6 months after the last ERCP, according to general condition, severity and frequency of pain, and health care encounters (emergency department visits, clinic visits, and hospital admissions related to the pancreatitis). RESULTS Mean age of the patients was 10.7 years (range 1.5 to 17 years). Abdominal pain was the main presenting symptoms with hyperamylasemia and hyperlipasemia. Clinical diagnoses included acute pancreatitis (6), recurrent pancreatitis (5), and chronic pancreatitis (11). The mean follow-up was 16.4 months. Nine patients had sphincter manometry, with abnormal results leading to biliary sphincterotomy in 4. Fifteen patients underwent a total of 23 therapeutic ERCP procedures unrelated to sphincter dysfunction. There were 2 complications of 34 procedures (6%), both being mild pancreatitis after sphincter manometry. There were no deaths. There was a significant reduction in frequency (p < 0.01) and severity of pain (p < 0.01) after intervention. Patients without pancreatographic changes of chronic pancreatitis had the most marked clinical improvement (p < 0.05). In those with ductal changes of chronic pancreatitis, clinical improvement was not predicted by the extent of ductal changes. There was a significant decrease in health care encounters (p < 0.05) and improvement in general condition (p < 0.01) after endoscopic therapy, especially in those with a normal pancreatogram. CONCLUSIONS Therapeutic ERCP is safe in pediatric patients with pancreatitis. Significant clinical improvement is achieved in patients with biliary or pancreatic stone disease. Prospective studies with long-term follow-up are needed to determine the impact of endoscopic therapy in patients with chronic pancreatitis and sphincter of Oddi dysfunction.

Transpapillary stenting of proximal biliary strictures: does biliary sphincterotomy reduce the risk of postprocedure pancreatitis?

BACKGROUND Pancreatitis after biliary stenting is a rare complication. To reduce this risk, some endoscopists routinely perform biliary sphincterotomy before stenting, but the value of this practice is not established. METHODS The incidence of pancreatitis was reviewed in patients undergoing biliary stenting with and without a biliary sphincterotomy. RESULTS Postprocedure pancreatitis occurred in 4 of 83 (4.8%) patients treated with transpapillary biliary stents. Patients with proximal biliary strictures were at significantly increased risk for postprocedure pancreatitis (4 of 24) versus those with distal or no strictures (0 of 59) (p = 0.006). The four patients with pancreatitis after stenting had not undergone sphincterotomy. Of those treated conservatively, two cases were graded severe (one fatal), and one was mild. The other patient was markedly symptomatic from pancreatitis, but improved dramatically after treatment with a needle-knife sphincterotomy done within 24 hours of the original ERCP. CONCLUSION The risk of pancreatitis following transpapillary biliary stenting is increased in patients with proximal biliary strictures. Such lesions (malignant or benign) may serve as a fulcrum, leading to medial deflection of the stent and compression of the pancreatic orifice. The hypothesis that sphincterotomy may decrease the risk of biliary stent-induced obstructive pancreatitis should be tested in patients with proximal biliary strictures.

Proximal migration of biliary stents: Attempted endoscopic retrieval in forty-one 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.

Commitment, confirmation, and clearance: new techniques for nonradiation ERCP during pregnancy (with videos).

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.

Short 5Fr vs Long 3Fr Pancreatic Stents in Patients at Risk for Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

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 articles video abstract, go to the AGAs YouTube Channel.

Oral allopurinol does not prevent the frequency or the severity of post-ERCP pancreatitis.

BACKGROUND Pancreatitis is the most common major complication of ERCP. Efforts have been made to identify pharmacologic agents capable of reducing its incidence and severity. The aim of this trial was to determine whether prophylactic allopurinol, an inhibitor of oxygen-derived free radical production, would reduce the frequency and severity of post-ERCP pancreatitis. Methods A total of 701 patients were randomized to receive either allopurinol or placebo 4 hours and 1 hour before ERCP. A database was prospectively collected by a defined protocol on patients who underwent ERCP. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis. RESULTS The groups were similar with regard to patient demographics and to patient and procedure risk factors for pancreatitis. The overall incidence of pancreatitis was 12.55%. It occurred in 46 of 355 patients in the allopurinol group (12.96%) and in 42 of 346 patients in the control group (12.14%; p = 0.52). The pancreatitis was graded mild in 7.89%, moderate in 4.51%, and severe in 0.56% of the allopurinol group, and mild in 6.94%, moderate in 4.62%, and severe in 0.58% of the control group. There was no significant difference between the groups in the frequency or the severity of pancreatitis. CONCLUSIONS Prophylactic oral allopurinol did not reduce the frequency or the severity of post-ERCP pancreatitis.

Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial

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 < .001). Given the prespecified noninferiority margin of -15%, the null hypothesis that cSEMS is less effective than plastic stents was rejected. The mean number of ERCPs to achieve resolution was lower for cSEMS (2.14) vs plastic (3.24; mean difference, 1.10; 95% CI, 0.74 to 1.46; P < .001). 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.