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Fully covered self-expanding metal stents (FCSEMS) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection, FCSEMS design, efficacy and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain.

Background & Aims: Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients. Methods: Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS vs FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of endoscopic retrograde cholangiopancreatography (ERCPs) and stents, and stent- or procedure-related serious adverse events. Results: Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs FCSEMS, respectively, stricture resolution status at 24 months was 77.1% (54/70) vs 75.8% (47/62) (P = .008 for noninferiority intention-to-treat analysis), mean number of ERCPs was 3.9 ± 1.3 vs 2.6 ± 1.3 (P < .001, intention-to-treat), and mean number of stents placed was 7.0 ± 4.4 vs 1.3 ± .6 (P < .001, as-treated). Serious adverse events occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P = .568), including cholangitis/fever/jaundice (9 vs 7 patients respectively), abdominal pain (5 vs 5), cholecystitis (1 vs 3) and post-ERCP pancreatitis (0 vs 2). No stent- or procedure-related deaths occurred. Conclusions: Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared with a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256.), SCOPUS: ar.j, info:eu-repo/semantics/published

Background and Aims: Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. Methods: Fourteen “expert” (>2000 lifetime ERCPs) and 5 “less-expert” endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events. Results: Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P =.131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P =.999), median ERCP completion time (25.0 vs 28.5 minutes, P =.130), mean cannulation attempts (2.8 vs 2.8, P =.954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P =.840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P <.001). Serious adverse events were reported in 13 patients (6.5%). Conclusions: In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.)

BACKGROUND & AIMS: Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients.METHODS: Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS versus FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of ERCPs and stents, and stent- or procedure-related serious adverse events (SAEs).RESULTS: Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs. FCSEMS respectively, stricture resolution status at 24 months was 77.1% (54/70) vs. 75.8% (47/62) (P=0.008 for noninferiority ITT analysis), mean number of ERCPs was 3.9±1.3 vs. 2.6±1.3 (P<0.001, ITT), and mean number of stents placed was 7.0±4.4 vs. 1.3±0.6 (P<0.001, as-treated). SAEs occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P=0.568), including cholangitis/fever/jaundice (9 vs. 7 patients respectively), abdominal pain (5 vs. 5), cholecystitis (1 vs. 3) and post-ERCP pancreatitis (0 vs. 2). No stent- or procedure-related deaths occurred.CONCLUSIONS: Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared to a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256).

Background and Aims: Temporary single, fully covered self-expanding metal stent (FCSEMS) placement for benign biliary strictures (BBSs) associated with chronic pancreatitis (CP) may require fewer interventions than endotherapy with multiple plastic stents and may carry less morbidity than biliary diversion surgery. This study aimed to assess long-term outcomes in CP-associated BBSs after FCSEMS placement and removal. Methods: In this open-label, multinational, prospective study, subjects with CP and a BBS treated with FCSEMS placement with scheduled removal at 10 to 12 months were followed for 5 years after FCSEMS indwell. Kaplan-Meier analyses assessed BBS resolution and cumulative probability of freedom from recurrent stent placement to 5 years after FCSEMS indwell. Results: One hundred eighteen patients were eligible for FCSEMS removal. At a median of 58 months (interquartile range, 44-64) post-FCSEMS indwell, the probability of remaining stent-free was 61.6% (95% confidence interval [CI], 52.5%-70.7%). In 94 patients whose BBSs resolved at the end of FCSEMS indwell, the probability of remaining stent-free 5 years later was 77.4% (95% CI, 68.4%-86.4%). Serious stent-related adverse events occurred in 27 of 118 patients (22.9%); all resolved with medical therapy or repeated endoscopy. Multivariate analysis identified severe CP (hazard ratio, 2.4; 95% CI, 1.0-5.6; P = .046) and longer stricture length (hazard ratio, 1.2; 95% CI, 1.0-1.4; P = .022) as predictors of stricture recurrence. Conclusion: In patients with symptomatic BBSs secondary to CP, 5 years after placement of a single FCSEMS intended for 10 to 12 months indwell, more than 60% remained asymptomatic and stent-free with an acceptable safety profile. Temporary placement of a single FCSEMS may be considered as first-line treatment for patients with CP and BBSs. (Clinical trial registration number: NCT 01014390.), info:eu-repo/semantics/published

Background and Aims: Minimally invasive treatments of anastomotic benign biliary stricture (BBS) after orthotopic liver transplantation (OLT) include endoscopic placement of multiple plastic stents or fully covered self-expandable metal stents (FCSEMSs). No multiyear efficacy data are available on FCSEMS treatment after OLT. Methods: We prospectively studied long-term efficacy and safety of FCSEMS treatment in adults aged ≥18 years with past OLT, cholangiographically confirmed BBS, and an indication for ERCP with stent placement. Stent removal was planned after 4 to 6 months, with subsequent follow-up until 5 years or stricture recurrence. Long-term outcomes were freedom from stricture recurrence, freedom from recurrent stent placement, and stent-related serious adverse events (SAEs). Results: In 41 patients, long-term follow-up began after FCSEMS removal (n = 33) or observation of complete distal migration (CDM) (n = 8). On an intention-to-treat basis, the 5-year probability of remaining stent-free after FCSEMS removal or observation of CDM was 48.9% (95% confidence interval [CI], 33.2%-64.7%) among all patients and 60.9% (95% CI, 43.6%-78.2%) among 31 patients with over 4 months of FCSEMS indwell time. In 28 patients with stricture resolution at FCSEMS removal or observed CDM (median, 5.0 months indwell time), the 5-year probability of no stricture recurrence was 72.6% (95% CI, 55.3%-90%). Sixteen patients (39%) had at least 1 related SAE, most commonly cholangitis (n = 10). Conclusions: By 5 years after temporary FCSEMS treatment of post-OLT BBS, approximately half of all patients remained stent-free on an intention-to-treat basis. Stent-related SAEs (especially cholangitis) were common. FCSEMS placement is a viable long-term treatment option for patients with post-OLT BBS. (Clinical trial registration number: NCT01014390.), SCOPUS: ar.j, info:eu-repo/semantics/published

Background and Aims: Preoperative biliary drainage with self-expanding metal stents (SEMSs) brings liver function within an acceptable range in preparation for neoadjuvant therapy (NATx) and provides relief of obstructive symptoms in patients with pancreatic cancer. We compared fully-covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs) for sustained biliary drainage before and during NATx. Methods: Patients with pancreatic cancer and planned NATx who need treatment of jaundice and/or cholestasis before pancreaticoduodenectomy were randomized to FCSEMSs versus UCSEMSs. The primary endpoint was sustained biliary drainage, defined as the absence of reinterventions for biliary obstructive symptoms, and was assessed from SEMS placement until curative intent surgery or at 1 year. Results: The intention-to-treat population included 119 patients (59 FCSEMSs, 60 UCSEMSs). Sustained biliary drainage was equally successful with FCSEMSs and UCSEMSs (72.2% vs 72.9%, noninferiority P =.01). Reasons for FCSEMS and UCSEMS failure differed significantly between the groups and included tumor ingrowth in 0% versus 16.7% (P <.01), and stent migration in 6.8% versus 0% (P =.03), respectively. Serious adverse event rates related to stent placement were not significantly different in both groups (23.7% [14/59] vs 20.0% [12/60], P =.66), as were acute cholecystitis rates when the gallbladder was in situ (9.3% [4/43] vs 4.8% [2/42], P =.68) for FCSEMSs and UCSEMSs, respectively. In our study, independent of stent type, predictors of reinterventions were 4-cm stent length and presence of the gallbladder. Conclusion: FCSEMSs and UCSEMSs provide similar preoperative management of biliary obstruction in patients with pancreatic cancer receiving NATx, but mechanisms of stent dysfunction depend on stent type, stent length, and presence of the gallbladder. (Clinical trial registration number: NCT02238847.), SCOPUS: ar.j, info:eu-repo/semantics/published

BACKGROUND: Endoscopic treatment of post-cholecystectomy biliary strictures (PCBS) with multiple plastic biliary stents placed sequentially is a minimally invasive alternative to surgery but requires multiple interventions. Temporary placement of a single fully-covered self-expanding metal stent (FCSEMS) may offer safe and effective treatment with fewer re-interventions. Long-term effectiveness of treatment with FCSEMS to obtain PCBS resolution has not yet been studied. METHODS: In this prospective multi-national study in patients with symptomatic benign biliary strictures (N = 187) due to various etiologies received a FCSEMS with scheduled removal at 6-12 months and were followed for 5 years. We report here long-term outcomes of the subgroup of patients with PCBS (N = 18). Kaplan Meier analyses assessed long-term freedom from re-stenting. Adverse events were documented. RESULTS: Endoscopic removal of the FCSEMS was achieved in 83.3% (15/18) of patients after median indwell of 10.9 (range 0.9-13.8) months. In the remaining 3 patients (16.7%), the FCSEMS spontaneously migrated and passed without complications. At the end of FCSEMS indwell, 72% (13/18) of patients had stricture resolution. At 5 years after FCSEMS removal, 84.6% (95% CI 65.0-100.0%) of patients who had stricture resolution at FCSEMS removal remained stent-free. In addition, at 75 months after FCSEMS placement, the probability of remaining stent-free was 61.1% (95% CI 38.6-83.6%) for all patients. Stent or removal related serious adverse events occurred in 38.9% (7/18) all resolved without sequalae. CONCLUSIONS: In patients with symptomatic PCBS, temporary placement of a single FCSEMS intended for 10-12 months indwell is associated with long-term stricture resolution up to 5 years. Temporary placement of a single FCSEMS may be considered for patients with PCBS not involving the main hepatic confluence. TRIAL REGISTRATION NUMBERS: NCT01014390; CTRI/2012/12/003166; Registered 17 November 2009., SCOPUS: ar.j, info:eu-repo/semantics/published

Background: Endoscopic treatment of post-cholecystectomy biliary strictures (PCBS) with multiple plastic biliary stents placed sequentially is a minimally invasive alternative to surgery but requires multiple interventions. Temporary placement of a single fully-covered self-expanding metal stent (FCSEMS) may offer safe and effective treatment with fewer re-interventions. Long-term effectiveness of treatment with FCSEMS to obtain PCBS resolution has not yet been studied. Methods: In this prospective multi-national study in patients with symptomatic benign biliary strictures (N = 187) due to various etiologies received a FCSEMS with scheduled removal at 6–12 months and were followed for 5 years. We report here long-term outcomes of the subgroup of patients with PCBS (N = 18). Kaplan Meier analyses assessed long-term freedom from re-stenting. Adverse events were documented. Results: Endoscopic removal of the FCSEMS was achieved in 83.3% (15/18) of patients after median indwell of 10.9 (range 0.9–13.8) months. In the remaining 3 patients (16.7%), the FCSEMS spontaneously migrated and passed without complications. At the end of FCSEMS indwell, 72% (13/18) of patients had stricture resolution. At 5 years after FCSEMS removal, 84.6% (95% CI 65.0–100.0%) of patients who had stricture resolution at FCSEMS removal remained stent-free. In addition, at 75 months after FCSEMS placement, the probability of remaining stent-free was 61.1% (95% CI 38.6–83.6%) for all patients. Stent or removal related serious adverse events occurred in 38.9% (7/18) all resolved without sequalae. Conclusions: In patients with symptomatic PCBS, temporary placement of a single FCSEMS intended for 10–12 months indwell is associated with long-term stricture resolution up to 5 years. Temporary placement of a single FCSEMS may be considered for patients with PCBS not involving the main hepatic confluence.