Impact and outcomes of research sponsored by the American Society for Gastrointestinal Endoscopy.

BACKGROUND AND AIMS: Since 1985, the American Society for Gastrointestinal Endoscopy (ASGE) has awarded grants for endoscopic-related research. The goals of this study were to examine trends in ASGE grant funding and to assess productivity of previous recipients of the ASGE grant awards. METHODS: This was a retrospective cohort analysis of all research grants awarded by the ASGE through 2009. Measures of academic productivity and self-assessment of the ASGE awards' impact on the recipients' careers were defined by using publicly available resources (eg, National Library of Medicine-PubMed) and administration of an electronic survey to award recipients. RESULTS: The ASGE awarded 304 grants totaling $12.5 million to 214 unique awardees. Funding increased 7.5-fold between 1985 and 1989 (mean $102,000/year) and between 2005 and 2009 (mean $771,000/year). The majority of awardees were men (83%), were at or below the level of assistant professor (82%), with a median of 3 years of postfellowship experience at the time of the award, and derived from a broad spectrum of institutions as measured by National Institutes of Health funding rank (median 26, interquartile range [IQR] 12-64). Nineteen percent had a master's degree in a research-related field. Awardees' median publications per year increased from 3.5 (IQR 1.2-9.0) before funding to 5.7 (IQR 1.8-9.5) since funding; P = .04, and median h-index scores increased from 3 (IQR 1-8) to 17 (IQR 8-26); P < .001. Multivariate analysis found that the presence of a second advanced degree (eg, masters or doctorate) was independently predictive of high productivity (odds ratio [OR] 2.92; 95% confidence interval [CI], 1.09-7.81). Among 212 unique grant recipients, 82 (40%) completed the online survey. Of the respondents, median peer-reviewed publications per year increased from 3.4 (IQR 1.9-5.5) to 4.5 (IQR 2.0-9.5); P = .17. Ninety-one percent reported that the ASGE grant had a positive or very positive impact on their careers, and 85% of respondents are currently practicing in an academic environment. Most of the grants resulted in at least 1 peer-reviewed publication (67% per Internet-based search and 81% per survey). CONCLUSIONS: The ASGE research program has grown considerably since 1985, with the majority of grants resulting in at least 1 grant-related publication. Overall academic productivity increased after the award, and the majority of awardees report a positive or very positive impact of the award on their careers. Medical professional societies are an important sponsor of clinical research.

The risk of post-ERCP pancreatitis and the protective effect of rectal indomethacin in cases of attempted but unsuccessful prophylactic pancreatic stent placement.

BACKGROUND: It is believed, based on limited observational data, that an unsuccessful attempt to place a prophylactic pancreatic stent substantially increases the risk of post-ERCP pancreatitis (PEP). OBJECTIVE: To better understand the risk of PEP in patients with failed pancreatic stent placement (FPS) and the impact of rectal indomethacin on this risk. DESIGN: Secondary analysis of randomized, controlled trial data. SETTING: University of Michigan and Indiana University. PATIENTS: A total of 577 clinical trial participants at elevated risk for PEP. INTERVENTIONS: Pancreatic stent placement. MAIN OUTCOME MEASUREMENTS: Within the placebo group, we compared PEP rates in patients with FPS, patients who underwent successful stent placement, and in those without a stent attempt. We also performed a regression analysis evaluating the association between FPS and PEP. To define the protective effect of indomethacin, we repeated these analyses in the indomethacin group and in the full study cohort. RESULTS: The incidence of PEP among patients in the placebo group who experienced FPS was 34.7%, significantly exceeding rates in patients who underwent successful stent placement (16.4%) and in those without a stent attempt (12.1%). After we adjusted for known PEP risk factors, FPS was found to be independently associated with PEP. Among the indomethacin group and in the full cohort, FPS was not associated with a higher risk of PEP. LIMITATIONS: Low event rate, FPS not prospectively captured. CONCLUSION: FPS appears to confer an increased risk of PEP, which is attenuated by rectal indomethacin administration. These findings highlight the importance of adequate training and proficiency before endoscopists attempt pancreatic stent placement and the routine use of rectal indomethacin in high-risk ERCP cases.

[Scores and stages in gastroenterology]. / Scores und Stadien in der Gastroenterologie.

Staging and grading are indispensable in clinical gastroenterology in order to determine disease activity or therapeutic outcomes in a systematic and reproducible way. Adequate diagnosis, patient care and appropriate therapy will often depend on accurate staging and grading. Some of the most commonly encountered diseases in clinical gastroenterology and gastrointestinal endoscopy are gastroesophageal reflux disease, peptic ulcer disease, gastrointestinal vascular disorders such as hemorrhoids and esophageal varices as well as inflammatory bowel diseases. Some of the clinically most useful pertinent indices are summarized in this section.

Does rectal indomethacin eliminate the need for prophylactic pancreatic stent placement in patients undergoing high-risk ERCP? Post hoc efficacy and cost-benefit analyses using prospective clinical trial data.

OBJECTIVES: A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach. METHODS: We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both. RESULTS: After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP. CONCLUSIONS: This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.

Effect of endoscopic stenting of malignant bile duct obstruction on quality of life.

BACKGROUND AND GOALS: Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. Although endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of our study was to determine whether endoscopic stenting for MBDO results in improved QOL. PATIENTS AND METHODS: Patients undergoing endoscopic retrograde cholangiopancreatography for MBDO and participating in a randomized trial comparing patency duration of 10 and 11.5-Fr biliary plastic stents, completed the Functional Assessment of Cancer Therapy-General questionnaire at baseline, at 1 month after stent insertion, and at 180 days after stent insertion. RESULTS: A total of 164 patients answered the QOL questionnaire at baseline, 95 patients answered the questionnaire at 30 days, and 54 patients answered the questionnaire at 180 days after stent insertion. Endoscopic biliary stenting resulted in a statistically significant improvement in overall score of QOL, and different aspects of QOL such as physical, emotional, and functional well-being. There was a statistically significant improvement in most of the symptoms specific for MBDO at 30 and 180 days after stenting. CONCLUSIONS: Endoscopic stenting significantly improves QOL in patients with MBDO, and, therefore, is an appropriate part of palliative treatment in this patient population.

A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis.

BACKGROUND: Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). METHODS: In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights. RESULTS: A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P=0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P=0.03). CONCLUSIONS: Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.).

Accuracy of magnetic resonance cholangiopancreatography in the diagnosis of pancreas divisum.

BACKGROUND: Patients with pancreas divisum may develop pancreatitis. Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard for diagnosing pancreas divisum. Magnetic resonance cholangiopancreatography (MRCP) is a non-invasive test reported to be highly accurate in diagnosing pancreas divisum. AIM: To evaluate the diagnostic accuracy of MRCP in detecting pancreas divisum at our institution. METHODS: We reviewed patients who underwent both ERCP and MRCP. Patients who had diagnostic endoscopic pancreatograms (ERP) after MRCP comprise the study population. Secretin was given in 113/146 patients (S-MRCP). The remaining 33/146 patients had MRCP without secretin. In 7/33 patients who underwent MRCP without secretin (21.2%), the studies were non-diagnostic and, therefore, this group was not further analyzed and the study focused on the S-MRCP group only. RESULTS: ERP identified pancreas divisum in 19/113 (16.8%) patients. S-MRCP identified 14/19 pancreas divisum and was false-positive in three cases (sensitivity 73.3%, specificity 96.8%, positive predictive value 82.4%, negative predictive value 94.8%). Of the eight patients with inaccurate S-MRCP, 5 (63%) had changes of chronic pancreatitis by ERP. This differs from the frequency of chronic pancreatitis by ERP in 24/105 (23%) patients with accurate MRCP findings. The ERCP findings of chronic pancreatitis were more frequent among incorrect S-MRCP interpretations than among correct interpretations (odds ratio [OR] 5.5 [95% confidence interval (CI) 1.3-25.3]). MRCP without secretin is non-diagnostic for pancreas divisum in a significant proportion of patients. S-MRCP had a satisfactory specificity for detecting pancreas divisum. However, the sensitivity of S-MRCP for the diagnosis of pancreas divisum was modest at 73.3%. This is low compared to previous smaller studies, which reported a sensitivity of MRCP of up to 100%.

Diagnosis and management of acute cholangitis.

Acute cholangitis is a potentially life-threatening systemic disease resulting from a combination of infection and obstruction of the biliary tree, secondary to different underlying etiologies. Common causes of cholangitis (eg, gallstones, benign and malignant biliary strictures) are well known. However, others (eg, immunoglobulin-G subclass-4-related sclerosing cholangitis) have been described only recently, are still under evaluation, and need to gain broader attention from clinicians. The diagnosis of acute cholangitis is based on clinical presentation and laboratory data indicating systemic infection, as well as diagnostic imaging modalities revealing signs of biliary obstruction and possibly an underlying etiology. The clinical presentation varies, and initial risk stratification is important to guide further management. Early medical therapy, including fluid resuscitation and appropriate antibiotic coverage, is of major importance in all cases, followed by a biliary drainage procedure and, if possible, definitive therapy of the underlying etiology. The type and timing of biliary drainage should be based on the severity of the clinical presentation, and the availability and feasibility of drainage techniques, such as endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography (PTC), and open surgical drainage. ERCP plays a central role in the management of biliary obstruction in patients with acute cholangitis. Endoscopic ultrasound-guided biliary drainage recently emerged as a possible alternative to PTC for second-line therapy if ERCP fails or is not possible.

Evaluation of supplemental cautery during endoluminal gastroplication for the treatment of gastroesophageal reflux disease.

BACKGROUND: Endoscopic suture plications at the cardia decreased gastroesophageal reflux disease (GERD) symptoms in short-term studies. Pull-through of submucosal sutures may lead to loss of efficacy. The application of cautery on mucosal surfaces may promote tissue adherence. This study aimed to compare the efficacy of endoluminal gastroplication (ELGP) using Endocinch with and without adjuvant cautery. METHODS: Vertical plications were created using ELGP. Patients were randomized to either ELGP alone or ELGP with an adjuvant bicap cautery. Patients were blinded to their randomization category and encouraged to take antisecretory medications if needed. Heartburn was scored on a scale of 0 (none), 1 (occasional), 2 (frequent), or 3 (daily). Patients undergoing a second antireflux procedure during the follow-up period were considered study failures and scored 3. RESULTS: Of the 18 patients enrolled in the study, 1 was lost to follow-up evaluation at 12 months and 2 could not be followed up at 24 months. The cautery group included 10 patients (9 men) with a mean age of 53.2 years. The group without cautery consisted of 8 patients (5 men) with a mean age of 50.4 years. The use of ELGP with cautery resulted in a trend toward greater improvement in several parameters (heartburn score, total percentage of time that pH was less than 4, and medication use) at 12 months than ELGP without cautery. These trends were not seen at 24 months, when all but 1 patient had ongoing symptoms, used daily proton pump inhibitor/H2-blocker, or went on to undergo a second antireflux procedure (2 Nissen and 3 Enteryx). CONCLUSIONS: Cautery numerically improved plication persistence, decreased esophageal acid exposure, and improved symptoms at 1 year compared with sutures alone. Little or no long-term efficacy of ELGP with or without cautery was observed after 2 years of follow-up evaluation.

Predicting pancreas divisum by inspection of the minor papilla: a prospective study.

BACKGROUND: Minor papilla (MP) cannulation remains difficult in some patients despite improved cannulation devices and techniques. Therefore, noninvasive methods to predict presence of pancreas divisum (Pdiv) are desired. If Pdiv could be recognized before any cannulation is attempted, appropriate attention could be focused on MP cannulation and prolonged major papilla attempt at pancreatogram can be avoided. AIM: To evaluate whether simple inspection of the MP during initial duodenal entry during endoscopic retrograde cholangiopancreatography (ERCP) can predict the presence of Pdiv. METHODS: Patients undergoing ERCP with intended pancreatic duct cannulation were included in the study. Assessment of the MP was made during a 30 to 60-second period of inspection including aspiration of duodenal luminal air with the endoscope. The probability of Pdiv based on the appearance of the MP was then estimated by assessing the size of the MP, the diameter of MP orifice, and whether juice was seen draining through the MP orifice. RESULTS: Two hundred and twelve patients were prospectively analyzed. The most common indications for ERCP were suspected sphincter of Oddi dysfunction (44.3%) and idiopathic pancreatitis (34.4%). Pancreatograms revealed Pdiv in 42 (19.8%). The MP appearance had 54.7% sensitivity and 90% specificity in detecting Pdiv (positive predictive value 57.5%, negative predicting value 88.9%). Seventy percent of the false positive patients had an obstructing pathology at the ventral duct that would explain the MP appearance. CONCLUSIONS: Certain features of the MP (enlarged papilla, open orifice) had a moderate predictive value for the presence of Pdiv or an obstruction at the major papilla. However, a significant number of patients with Pdiv did not have these features.

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.

Palliation of gastric outlet obstruction and proximal small bowel obstruction with self-expandable metal stents: a single center series.

BACKGROUND: Self-expandable metal stents (SEMS) are being increasingly used to palliate malignant stenoses of the gastric outlet and proximal small bowel. Accordingly, we reviewed our experience in this setting. METHODS: Patients with gastric outlet or proximal small bowel stents were identified by reviewing hospital charts. Outcome criteria included survival data, need for reintervention, and clinical improvement. RESULTS: A total of 52 SEMS were placed in 36 patients with nonesophageal upper GI stenosis. Initial stent placement was successful in 92% and clinical improvement documented in 75%. Mean survival of patients who eventually died was 3.5 months. Seven patients are alive (mean follow-up, 5.0 months). Stent dysfunction occurred in 36% and required subsequent interventions. Biliary obstruction was documented in 50% of patients, 12 of whom had previously undergone biliary stenting and 5 who needed subsequent biliary decompression. CONCLUSIONS: Enteral stent placement has been reported to be an effective alternative for palliation of high-risk surgical patients with malignant gastric outlet and small bowel obstruction. Considering the short life expectancy of these patients and significant complications including stent migration, perforation, biliary obstruction, and need for subsequent endoscopic, radiologic and surgical interventions, the authors suggest that this procedure be performed in experienced centers on selected patients only and that biliary decompression be ensured early.