Search

ObjectivesIn 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.MethodsThe 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.ResultsThe trial is powered to detect a 33% risk reduction of acute pancreatitis frequency.ConclusionsThe 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.

Greater availability of less invasive biliary imaging to rule out choledocholithiasis should reduce the need for diagnostic endoscopic retrograde cholangiopancreatography (ERCP) in patients who have a remote history of cholecystectomy. The primary aims were to determine the incidence, characteristics, and outcomes of individuals who undergo first-time ERCP >1 year after cholecystectomy (late-ERCP). Data from a commercial insurance claim database (Optum Clinformatics) identified 583,712 adults who underwent cholecystectomy, 4274 of whom underwent late-ERCP, defined as first-time ERCP for nonmalignant indications >1 year after cholecystectomy. Outcomes were exposure and temporal trends in late-ERCP, biliary imaging utilization, and post-ERCP outcomes. Multivariable logistic regression was used to examine patient characteristics associated with undergoing late-ERCP. Despite a temporal increase in the use of noninvasive biliary imaging (35.9% in 2004 to 65.6% in 2021; P <.001), the rate of late-ERCP increased 8-fold (0.5–4.2/1000 person-years from 2005 to 2021; P <.001). Although only 44% of patients who underwent late-ERCP had gallstone removal, there were high rates of post-ERCP pancreatitis (7.1%), hospitalization (13.1%), and new chronic opioid use (9.7%). Factors associated with late-ERCP included concomitant disorder of gut-brain interaction (odds ratio [OR], 6.48; 95% confidence interval [CI], 5.88–6.91) and metabolic dysfunction steatotic liver disease (OR, 3.27; 95% CI, 2.79–3.55) along with use of anxiolytic (OR, 3.45; 95% CI, 3.19–3.58), antispasmodic (OR, 1.60; 95% CI, 1.53–1.72), and chronic opioids (OR, 6.24; 95% CI, 5.79–6.52). The rate of late-ERCP postcholecystectomy is increasing significantly, particularly in patients with comorbidities associated with disorder of gut-brain interaction and mimickers of choledocholithiasis. Late-ERCPs are associated with disproportionately higher rates of adverse events, including initiation of chronic opioid use. [Display omitted] [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Data on ERCP nurses and associate (ERCP-NA) training and comfort are lacking. Healthcare industry representative (HCIR) influence may be greater in low-volume units (LVUs) due to decreased procedure and device familiarity.Aim: The aim of this study was to compare ERCP-NA training, safety, and HCIR relationships between LVU and high-volume unit (HVU) ERCP facilities.Methods: We conducted an electronic survey of all Society of Gastroenterology Nurses and Associates (SGNA) members assessing: (1) demographics and procedure volume, (2) ERCP training and radiation safety, and (3) HCIR interactions. Responses were stratified by ERCP volume.Results: Among 832 SGNA member respondents (median age 55), 615 (74%) worked as an ERCP-NA; 41% derived from LVUs. The majority of ERCP-NAs, irrespective of unit volume, had observed <50 ERCPs before starting. Except for lead glasses, the majority (>80%) adhered to basic radiation safety, irrespective of unit volume. LVUs were more likely than HVU ERCP-NAs to agree that HCIRs were requested for intra-procedure assistance (24 vs. 19%, p = 0.008), asked for input on the next choice of device (22 vs. 15%, p = 0.01), and assist in device usage (27 vs. 22%, p = 0.04). Irrespective of volume, 30% agreed that they were more likely to utilize a company's devices if that HCIR was present.Conclusions: ERCP-NA training before independent participation in ERCP is suboptimal. HCIRs are frequently requested for assistance during ERCPs, especially in LVUs. HCIR impact on ERCP outcomes and device utilization and whether enhanced ERCP-NA training will impact the role of HCIR, require further study. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The combination of prophylactic pancreatic stent placement (PSP) - a temporary plastic stent placed in the pancreatic duct - and rectal non-steroidal anti-inflammatory drugs (NSAIDs) is recommended for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. Preliminary data, however, suggest that PSP may be unnecessary if rectal NSAIDs are administered. Given the costs and potential risks of PSP, we aim to determine whether rectal indomethacin obviates the need for pancreatic stent placement in patients undergoing high-risk ERCP.Methods/design: The SVI (Stent vs. Indomethacin) trial is a comparative effectiveness, multicenter, randomized, double-blind, non-inferiority study of rectal indomethacin alone versus the combination of rectal indomethacin and PSP for preventing PEP in high-risk cases. One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention, will be randomized to indomethacin alone or combination therapy. Those who are aware of study group assignment, including the endoscopist, will not be involved in the post-procedure care of the patient for at least 48 hours. Subjects will be assessed for PEP and its severity by a panel of independent and blinded adjudicators. Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups. Biological specimens will be obtained from trial participants and centrally banked.Discussion: The SVI trial is designed to determine whether PSP remains necessary in the era of NSAIDs pharmacoprevention. The associated bio-repository will establish the groundwork for important scientific breakthrough.Trial Registration: NCT02476279, registered June 2015. [ABSTRACT FROM AUTHOR]

Background and Aim There are no data specifically correlating early intravenous volume infusion ( IVI) with the length of hospitalization for postendoscopic retrograde cholangiopancreatography ( ERCP) pancreatitis ( PEP). Methods We conducted a retrospective cohort study of patients admitted within 24 h after ERCP to our institute with PEP. IVI during the first 24 h after ERCP was assessed. Primary outcome was severity of PEP, defined by length of hospitalization according to consensus guidelines: mild ≤ 3, moderate 4-10, and severe > 10 days. Results Of 72 eligible patients, 41 (56.9%) had mild and 31 (43.1%) moderate/severe PEP. Both groups had comparable demographics, indications, and procedural factors except patients with moderate/severe PEP were older (median age 49 vs 36 years, P = 0.05) and more likely to be discharged and readmitted within the first 24 h (41.9% vs 14.6%, P < 0.01). Patients with mild PEP received significantly greater IVI during the first 24 h (2834 mL [2046, 3570] vs 2044 mL [1227, 2875], P < 0.02) and 50% more fluid post- ERCP (2270 mL [1435, 2961] vs 1515 [950-2350], P < 0.02) compared with those with at least moderate PEP. Conclusion In patients with PEP, greater IVI during the first 24 h after ERCP is associated with reduced length of hospitalization. Lower IVI was more commonly observed in individuals who were discharged and then readmitted during the first 24 h. [ABSTRACT FROM AUTHOR]

Background and Study Aims: Among cases of difficult biliary cannulation, alternatives include use of a pancreatic duct stent (PDS) or guidewire (PDW) to facilitate access. We compared the effectiveness of a PDS versus a PDW to facilitate common bile duct (CBD) cannulation. Patients and Methods: We conducted a randomized, crossover trial at two endoscopy referral centers, limited to patients undergoing ERCP without a history of biliary sphincterotomy. After meeting predefined criteria for difficult cannulation, patients were randomized to using a PDS or PDW to facilitate CBD cannulation. Outcomes included cannulation rate within 6 min, overall cannulation rate, frequency of precut, and complication rates. Results: Among 442 eligible patients, 87 (19.7 %) met criteria for difficult cannulation. Forty two were randomized to PDW, 54 to PDS (including 9 PDW patients crossed over to PDS). The rate of CBD cannulation within 6 min was similar in the PDW (38.1 %) and PDS (51.9 %) groups ( p = 0.18). In a secondary analysis limited to patients who successfully underwent PDW or PDS deployment, the rate was also comparable (PDW 59.3 %, PDS 65.1 %; p = 0.62). The overall frequency of CBD cannulation was 66.7 % in PDW and 90.7 % in PDS patients. Precut was required in 9.5 % of PDW and 25.9 % of PDS patients. Complication rates were similar, with 4 (4.6 %) patients having post-ERCP pancreatitis and 1 (1.1 %) having post-ERCP pain without confirmation of pancreatitis. Conclusions: Use of a PDS or PDW facilitates CBD cannulation while maintaining a low complication rate and reducing the need for precut sphincterotomy in the majority of cases. [ABSTRACT FROM AUTHOR]

Background & Aims: Many advances have been made in pancreatobiliary imaging and endoscopy techniques. However, little is known about trends in use of endoscopic retrograde cholangiopancreatography (ERCP). Methods: We performed a retrospective cohort study that analyzed data from 33,596 ERCPs performed at Indiana University Medical Center from 1994 to 2009. Data from all patients were entered into an endoscopy database. We compared changes in patient demographics, indications for ERCP, and utilization of specific ERCP therapies during this time period. Results: The annual volume of ECRP increased steadily from 1175 in 1994 to 2802 in 2009 (P < .0001). Of all patients, 33.9% had previously undergone an ERCP at a different facility; 42.3% of these were unsuccessful. The odds of having undergone a failed ERCP at another facility increased slightly each year (odds ratio, 1.02; P < .001). Among patients who had a failed ERCP elsewhere, the success rate at Indiana University Medical Center was 96.1%. The frequency of patients with American Society of Anesthesiologists class ≥3 (odds ratio, 1.12; P < .001) who received anesthesia-administered sedation increased each year (odds ratio, 1.25; P < .001). Most ERCPs were performed for common bile duct stones or strictures and suspected sphincter of Oddi dysfunction (77.2%). The most rapid increase was among procedures for common bile duct strictures or leaks, pancreatic duct stones or strictures, and suspected sphincter of Oddi dysfunction. Rates of biliary sphincterotomy did not change (P = .252), but the frequency of pancreatic sphincterotomy, common bile duct, or pancreatic duct stent placement and pancreatic duct stricture dilation increased during this time (P < .001 for each). Conclusions: At a referral center, ERCP has become increasingly complex. From 1994 to 2009, increasing numbers of ERCPs have been performed for patients with more comorbidities, higher-grade disease, history of failed ERCPs, and on those receiving endotherapy. [Copyright &y& Elsevier]

Although the endoscopic management of bile leaks after cholecystectomy (CCY) is well established, the yield of a routine endoscopic retrograde cholangiogram (ERC) with a bile duct sweep at the time of stent removal is unclear. This study aimed to describe the prevalence of abnormal findings at follow-up ERC to determine whether upper endoscopy with stent removal and without cholangiography would suffice. A retrospective cohort analysis of all patients referred for initial and follow-up ERC with post-CCY bile leak was performed. The rate of abnormal findings was measured including choledocholithiasis, biliary strictures, and persistent bile leaks at follow-up ERC. Secondarily, the study sought to define the clinical characteristics of patients who demonstrated stones or sludge at follow-up assessment. Between January, 2003 and April, 2008, 105 patients underwent initial and follow-up ERC. After a mean interval of 6.9 ± 2.7 weeks between endoscopies, 29 (27.6%) of the 105 patients demonstrated one or more abnormalities including persistent bile leak ( n = 8), common bile duct (CBD) stones ( n = 12), and CBD sludge alone ( n = 9). In the subgroup analysis of the patients who underwent a balloon sweep at initial and follow-up ERC, the prevalence of CBD stones or sludge at the follow-up ERC was 17.6%. Besides stones during the initial ERC, no significant clinical predictors of CBD stones were found at follow-up ERC including surgical approach, interval between endoscopies, and location of bile leak. After endoscopic treatment of a bile leak, the prevalence of abnormalities at follow-up ERC is significant. A repeat cholangiogram with a balloon sweep is preferred at the time of stent removal. [ABSTRACT FROM AUTHOR]

The article focuses on endoscopic retrograde cholangiopancreatography (ERCP). They can provide many clinical benefits, but can cause serious complications also. The average cannulation rate was 85% after 200 ERCPs, but the 95% confidence interval spanned 70% and 90%. The number of cases required will depend on the quality of the teaching.

The prognosis is poor for most patients with pancreatic cancer, chronic pancreatitis, or other pancreatic diseases. Advances in pancreatic imaging could help identify these diseases at earlier stages, when they are easier to treat. Radiographic imaging and endoscopic imaging of the pancreas have progressed from the abdominal roentogram and endoscopic retrograde pancreatography to multi-detector computed tomography, magnetic resonance cholangiopancreatography, endoscopic ultrasonography, and pancreatoscopy. These technologies have improved the diagnosis and treatment of benign disease but have not significantly increased our ability to detect early-stage disease or affect outcomes of patients with pancreatic cancer or chronic pancreatitis. Advances in endoscopic imaging and molecular-based radiographic tests could allow physicians to identify pancreatic lesions and their precursors at earlier stages. Furthermore, research studies that include these tools could improve our understanding of disease pathogenesis and identify diagnostic markers and therapeutic targets. We review endoscopic imaging modalities, focusing on new endoscopic and molecular-based radiographic imaging tests that have the potential to substantially improve diagnosis and treatment of pancreatic disease. [ABSTRACT FROM AUTHOR]

Background & Aims: The role of sphincter of Oddi manometry (SOM) in the management of patients with idiopathic recurrent acute pancreatitis requires clarification. We evaluated the therapeutic effects of endoscopic sphincterotomy in patients with recurrent acute pancreatitis and the prognostic significance of pancreatic sphincter dysfunction (SOD). Methods: We performed a randomized trial of endoscopic retrograde cholangiopancreatography with SOM for patients with idiopathic recurrent acute pancreatitis. Patients with pancreatic SOD (n = 69) were assigned randomly to groups that received only biliary sphincterotomy (BES) or a combination of biliary and pancreatic sphincterotomy (DES); patients who underwent normal SOM (n = 20) were assigned randomly to groups that received BES or a sham surgery. The primary outcome was incidence of recurrent acute pancreatitis during the follow-up period (minimum, 1 year; maximum, 10 years). We also determined the incidence of chronic pancreatitis and analyzed factors associated with recurrence of acute pancreatitis. Results: Among the 69 patients with SOD, 48.5% who received BES and 47.2% who received DES had recurrent acute pancreatitis (95% confidence interval, −22.3 to 24.9; P = 1.0). In patients with normal SOM (n = 20), 27.3% of those who received BES and 11.1% of those who received the sham surgery had recurrent acute pancreatitis (95% confidence interval, −49.5 to 17.2; P = .59). Overall, 16.9% of subjects developed chronic pancreatitis during a median follow-up period of 78 months (interquartile range, 35−108 mo). The odds of recurrent acute pancreatitis during follow-up evaluation were significantly greater among patients with SOD than those with normal SOM (unadjusted hazard ratio, 3.5; 95% confidence interval, 1.07–11.4; P < .04), and remained so after adjusting for potential confounders (hazard ratio, 4.3; 95% confidence interval, 1.3−14.5; P < .02). Conclusions: Among patients with pancreatic SOD, DES and BES have similar effects in preventing recurrence of acute pancreatitis. Pancreatic SOD is an independent prognostic factor, identifying patients at higher risk for recurrent acute pancreatitis. Clinical Trials Registration: Clinicaltrials.gov (NCT01583517). [Copyright &y& Elsevier]

Background & Aims: Among patients undergoing advanced endoscopy, unrecognized obstructive sleep apnea (OSA) could predict sedation-related complications (SRCs) and the need for airway maneuvers (AMs). By using an OSA screening tool, we sought to define the prevalence of patients at high risk for OSA and to correlate OSA with the frequency of AMs and SRCs. Methods: We enrolled 231 consecutive patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) (n = 176) and endoscopic ultrasound (n = 55). Propofol-based sedation and patient monitoring were performed by a nurse anesthetist and an anesthesiologist. A previously validated screening tool for OSA (STOP-BANG) was used to identify patients at high risk for OSA (score, ≥3 of 8; SB+) or low risk (SB−). AMs were defined as a chin lift, modified mask ventilation, nasal airway, bag-mask ventilation, and endotracheal intubation. SRCs were defined as any duration of pulse oximetry less than 90%, systolic blood pressure less than 90 mm Hg, apnea, or early procedure termination. Results: The prevalence of SB+ was 43.3%. The frequency of hypoxemia was significantly higher among patients with SB+ than SB− (12.0% vs 5.2%; relative risk [RR], 1.83; 95% confidence interval [CI], 1.32–2.54). The rate of AMs was also significantly higher among SB+ (20.0%) compared with SB− (6.1%) patients (RR, 1.8; 95% CI, 1.3–2.4). These rates remained significant after adjusting for American Society of Anesthesiologists class 3 or higher (RR, 1.70; 95% CI, 1.28–2.2 for AMs; RR, 1.63; 95% CI, 1.19–2.25 for hypoxemia). Each element of the STOP-BANG was reported more commonly in SB+ patients (P < .0001 for each comparison). Conclusions: A significant number of patients undergoing advanced endoscopic procedures are at risk for OSA. AMs and hypoxemia occur at an increased frequency in these patients. [ABSTRACT FROM AUTHOR]