Background and Aims Endoscopic transmural drainage/debridement of pancreatic walled-off necrosis (WON) has been performed using double-pigtail plastic (DP), fully covered self-expanding metal stents ...(FCSEMSs), or the novel lumen-apposing fully covered self-expanding metal stent (LAMS). Our aim was to perform a retrospective cohort study to compare the clinical outcomes and adverse events of EUS-guided drainage/debridement of WON with DP stents, FCSEMSs, and LAMSs. Methods Consecutive patients in 2 centers with WON managed by EUS-guided debridement were divided into 3 groups: (1) those who underwent debridement using DP stents, (2) debridement using FCSEMSs, (3) debridement using LAMSs. Technical success (ability to access and drain a WON by placement of transmural stents), early adverse events, number of procedures performed per patient to achieve WON resolution, and long-term success (complete resolution of the WON without need for further reintervention at 6 months after treatment) were evaluated. Results From 2010 to 2015, 313 patients (23.3% female; mean age, 53 years) underwent WON debridement, including 106 who were drained using DP stents, 121 using FCSEMSs, and 86 using LAMSs. The 3 groups were matched for age, cause of the pancreatitis, WON size, and location. The cause of the patients' pancreatitis was gallstones (40.6%), alcohol (30.7%), idiopathic (13.1%), and other causes (15.6%). The mean cyst size was 102 mm (range, 20-510 mm). The mean number of endoscopy sessions was 2.5 (range, 1-13). The technical success rate of stent placement was 99%. Early adverse events were noted in 27 of 313 (8.6%) patients (perforation in 6, bleeding in 8, suprainfection in 9, other in 7). Successful endoscopic therapy was noted in 277 of 313 (89.6%) patients. When comparing the 3 groups, there was no difference in the technical success ( P = .37). Early adverse events were significantly lower in the FCSEMS group compared with the DP and LAMS groups (1.6%, 7.5%, and 9.3%; P < .01). At 6-month follow-up, the rate of complete resolution of WON was lower with DP stents compared with FCSEMSs and LAMSs (81% vs 95% vs 90%; P = .001). The mean number of procedures required for WON resolution was significantly lower in the LAMS group compared with the FCSEMS and DP groups (2.2 vs 3 vs 3.6, respectively; P = .04). On multivariable analysis, DP stents remain the sole negative predictor for successful resolution of WON (odds ratio OR, 0.18; 95% confidence interval, 0.06-0.53; P = .002) after adjusting for age, sex, and WON size. Although there was no significant difference between FCSEMSs and LAMSs for WON resolution, the LAMS was more likely to have early adverse events (OR, 6.6; P = .02). Conclusions EUS-guided drainage/debridement of WON using FCSEMSs and LAMSs is superior to DP stents in terms of overall treatment efficacy. The number of procedures required for WON resolution was significantly lower with LAMSs compared with FCSEMSs and DP stents.
Background and Aims EUS-guided biliary drainage (EUS-BD) is increasingly used as an alternate therapeutic modality to percutaneous transhepatic biliary drainage (PTBD) for biliary obstruction in ...patients who fail ERCP. We conducted a systematic review and meta-analysis to compare the efficacy and safety of these 2 procedures. Methods We searched several databases from inception to September 4, 2016 to identify comparative studies evaluating the efficacy and safety of EUS-BD and PTBD. Primary outcomes of interest were the differences in technical success and postprocedure adverse events. Secondary outcomes of interest included clinical success, rate of reintervention, length of hospital stay, and cost comparison for these 2 procedures. Odds ratios (ORs) and standard mean difference were calculated for categorical and continuous variables, respectively. These were analyzed using random effects model of meta-analysis. Results Nine studies with 483 patients were included in the final analysis. There was no difference in technical success between 2 procedures (OR, 1.78; 95% CI, .69-4.59; I2 = 22%) but EUS-BD was associated with better clinical success (OR, .45; 95% CI, .23-.89; I2 = 0%), fewer postprocedure adverse events (OR, .23; 95% CI, .12-.47; I2 = 57%), and lower rate of reintervention (OR, .13; 95% CI, .07-.24; I2 = 0%). There was no difference in length of hospital stay after the procedures, with a pooled standard mean difference of –.48 (95% CI, –1.13 to .16), but EUS-BD was more cost-effective, with a pooled standard mean difference of –.63 (95% CI, –1.06 to –.20). However, the latter 2 analyses were limited by considerable heterogeneity. Conclusions When ERCP fails to achieve biliary drainage, EUS-guided interventions may be preferred over PTBD if adequate advanced endoscopy expertise and logistics are available. EUS-BD is associated with significantly better clinical success, lower rate of postprocedure adverse events, and fewer reinterventions.
Background and Aims Endoscopic retrograde pancreatography (ERP) is considered first-line therapy for management of symptomatic pancreatic duct obstruction. Technical failure with ERP occurs when the ...main pancreatic duct cannot be cannulated. EUS-guided drainage of the pancreatic duct is a minimally invasive alternative to surgery for failed conventional ERP. We present an international, multicenter study on the safety and efficacy of EUS-guided pancreatic drainage (EUS-PD) for patients who fail conventional endoscopic therapy. Methods Between January 2006 and December 2015, 80 patients underwent EUS-PD at 4 academic centers in 3 countries. Patient demographics, medical history, procedure data, and follow-up clinical data were collected. Technical success was defined as successful pancreatic duct drainage with stent placement. Clinical success was defined as resolution or improvement of symptoms or improvement on postprocedure imaging. Results Eighty patients (62.5% men; mean age, 58.2 ± 15.5 years) were included. All patients had attempted ERP and/or extracorporeal lithotripsy if needed before EUS-PD. Technical success was achieved in 89% of patients (n = 71). Clinical success was achieved in 81% of patients overall (65/80) and in 92% of patients who achieved technical success (65/71). Immediate adverse events occurred in 20% of patients (n = 16) and delayed adverse events occurred in 11% of patients (n = 9). Conclusions With appropriate endoscopic expertise, EUS-PD offers a minimally invasive, more effective, and safer alternative to some surgical PD procedures. Prospective studies are needed to evaluate long-term outcomes. (Clinical trial registration number: NCT01522573 .)
Background Characterization of indeterminate biliary strictures remains problematic. Tissue sampling is the criterion standard for confirming malignancy but has low sensitivity. Probe-based confocal ...laser endomicroscopy (pCLE) showed excellent sensitivity in a registry; however, it has not been validated in a prospective study. Objective To prospectively validate pCLE in real time during ERCP for indeterminate biliary strictures. Design Prospective, international, multicenter study. Setting Six academic centers. Patients A total of 136 patients with indeterminate biliary strictures. Interventions Investigators provided a presumptive diagnosis based on the patient history, ERCP impression, and pCLE during the procedure before and after tissue sampling results were available. A presumptive diagnosis also was made separately by a blinded investigator during ERCP and after tissue sampling to estimate care without pCLE. Follow-up was at least 6 months. Main Outcome Measurements Accuracy, sensitivity, and specificity during ERCP alone, ERCP with pCLE, and ERCP with pCLE and tissue sampling. Results A total of 112 patients were evaluated (71 with malignant lesions). Tissue sampling alone was 56% sensitive, 100% specific, and 72% (95% confidence interval CI, 63%-80%) accurate. pCLE with ERCP was 89% sensitive, 71% specific, and 82% (95% CI, 74%-89%) accurate. After tissue sampling returned, strictures could be characterized with 88% (95% CI, 81%-94%) accuracy. Limitations No randomization of care maps. pCLE not blinded. Conclusion pCLE provided a more accurate and sensitive diagnosis of cholangiocarcinoma compared with tissue sampling alone. Incorporation of pCLE into the diagnostic armamentarium of patients with indeterminate biliary strictures may allow for a more accurate assessment, potentially reducing delays in diagnosis and costly repeat testing. (Clinical trial registration number: NCT01392274 .)
Abstract Background Per-oral endoscopic myotomy (POEM) has become an accepted treatment for patients with achalasia. Despite its excellent efficacy rate of greater than 80%, a small percentage of ...patients remain symptomatic postprocedure. Limited data exist as to the best management for recurrence of symptoms after POEM. We present the first international, multicenter experience on the efficacy and safety of a repeat POEM in the management of achalasia. Methods Patients who underwent a redo POEM from 15 centers in 9 countries were included in a dedicated registry. Technical success was defined as successful completion of a second myotomy. Clinical success was defined as an Eckardt score of less than or equal to 3 after the second myotomy. Adverse events including anesthesia-related, operative, and postoperative adverse events were recorded. Results A total of 46 patients were included in the study. Average age was 49.3 years ± 16.78. 20 (45%) patients were male. The mean pre redo-POEM Eckardt score was 4.3 ± 2.48. Technical success was achieved in 46 (100%) patients. Clinical success was achieved in 41 patients (85%). The average post-POEM Eckardt score was 1.64 ± 1.67, with a significant difference of 2.58 (p<0.00001). 8 patients (17%) had adverse events consisting of procedural bleeding, all managed endoscopically. There were no deaths. No POEMs were aborted or required surgical conversion or assistance. Discussion For patients with persistent symptoms after POEM, repeat POEM appears to be an efficacious and safe technique. Further randomized trial comparing redo POEM versus Heller should be considered.
Background and Aims The role of endoscopic submucosal dissection (ESD) in Barrett’s early neoplasia is not well defined, with most studies originating from Asia and Europe. We aimed to assess the ...efficacy, safety, and results of ESD in Barrett’s esophagus (BE) with high-grade dysplasia (HGD) and early adenocarcinoma (EAC) across centers in the United States. Methods Multicenter retrospective analysis on 46 patients with BE who underwent ESD for BE-HGD or EAC, or both, between January 2010 and April 2015. The primary endpoint was the rate of en bloc resection. Secondary aims included rate of R0 (complete) and curative resection, a comparison of pre- and post-ESD histology, procedure-related adverse events, and rate of remission at follow-up. Results Median age was 69 years (range, 42-82 years). The median resected specimen size was 45 mm (range, 13-125 mm). En bloc and curative resection rates were 96% (44/46) and 70% (32/46), respectively. Most lesions (11/20; 55%) diagnosed as BE-HGD on biopsy were upstaged to intramucosal or invasive EAC on post-ESD histopathology. There were 4 early (<48 hours) adverse events (3 bleeding and 1 perforation), and all were treated endoscopically. Seven patients (15%) developed esophageal strictures that were managed endoscopically. Complete remission of BE neoplasia was found in 100% (32/32) of patients with curative resection at median follow-up of 11 months (range, 2-25 months). Conclusions This is the largest multicenter series of ESD for early neoplastic BE from the United States. ESD appears to be safe and effective, with high en bloc and curative resection rates in the treatment of early BE neoplasia.
Background Endoscopic transmural drainage of pancreatic pseudocysts (PPs) by using double-pigtail (DP) plastic stents requires placement of multiple stents and can be restricted by inadequate ...drainage and leakage risk. Recently, the use of fully covered self-expanding metal stents (FCSEMSs) has been reported as an alternative to DP plastic stents. Objective To evaluate the clinical outcomes, success rate, and adverse events of EUS-guided drainage of PPs with DP plastic stents and FCSEMSs. Design Retrospective cohort study. Setting Two tertiary-care academic medical centers. Patients This study involved 230 patients (mean age, 52.6 years) with PPs who underwent EUS-guided transmural drainage including 118 that were drained by using DP plastic stents and 112 by using FCSEMSs. A transgastric approach was used in 210 patients (91%), and transduodenal drainage was performed in 20 patients (9%). Interventions Stent deployment under EUS guidance. Main Outcome Measurements Technical success, early adverse events, stent occlusion requiring reintervention, and long-term success. Results At 12-month follow-up after the initial procedure, complete resolution of PPs by using DP plastic stents was lower compared with those that underwent drainage with FCSEMSs (89% vs 98%; P = .01). Procedural adverse events were noted in 31% in the DP plastic stent group and 16% in the FCSEMS group ( P = .006). On multivariable analysis, patients with plastic stents were 2.9 times more likely to experience adverse events (odds ratio 2.9; 95% confidence interval, 1.4-6.3). Limitations Retrospective study. Conclusion In patients with PPs, EUS-guided drainage by using FCSEMSs improves clinical outcomes and lowers adverse event rates compared with those drained with DP plastic stents.
Background EUS-guided biliary drainage (BD) is an evolving alternative technique for patients with malignant biliary obstruction for which ERCP failed. Objective To compare the outcomes of 2 ...nonanatomic EUS-guided BD routes: hepaticogastrostomy (HPG) and choledochoduodenostomy (CD). Design Prospective, randomized trial. Setting Tertiary endoscopic referral center. Patients Forty-nine patients with unresectable distal malignant biliary obstruction and failed ERCP were included. The HPG group had 25 patients and the CD group had 24 patients. Interventions EUS-guided HPG or CD. In all procedures, a biliary puncture with a 19-gauge needle followed by cholangiography, wire advancement, track dilation, and self-expandable metal stent deployment were performed. Main Outcome Measurements Technical and clinical success, quality of life, adverse events, and survival. Results The technical success rate was 96% for HPG and 91% for CD. The clinical success rate was 91% for HPG and 77% for CD. The mean procedural time was 47.8 minutes for HPG and 48.8 minutes for CD. The mean scores of quality of life were similar during follow-up. The overall adverse event rate was 16.3% (20% for the HPG group and 12.5% for the CD group). One patient with a bile leak required percutaneous biloma drainage. There was no statistical difference between the 2 techniques and no difference with regard to survival time between the 2 groups. Limitations Single-center study. Conclusion HPG and CD techniques are similar in efficacy and safety. Both HPG and CD seem valid alternative options for BD in patients with distal malignant biliary obstruction after failed ERCP.
Background and Aims The efficacy and safety of endoscopic gallbladder drainage (EGBD) performed via endoscopic retrograde cholangiography (ERC)-based transpapillary stenting or EUS-based transmural ...stenting are unknown. We aimed to conduct a proportion meta-analysis to evaluate the cumulative efficacy and safety of these procedures and to compare them with percutaneous gallbladder drainage (PGBD). Methods We searched several databases from inception through December 10, 2015 to identify studies (with 10 or more patients) reporting technical success and postprocedure adverse events of EGBD. Weighted pooled rates (WPRs) for technical and clinical success, postprocedure adverse events, and recurrent cholecystitis were calculated for both methods of EGBD. Pooled odds ratios (ORs) were also calculated to compare the technical success and postprocedure adverse events in patients undergoing EGBD versus PGBD. Results The WPRs with 95% confidence intervals (CIs) of technical success, clinical success, postprocedure adverse events, and recurrent cholecystitis for ERC-based transpapillary drainage were 83% (95% CI, 78%-87%; I2 = 38%), 93% (95% CI, 89%-96%; I2 = 39%), 10% (95% CI, 7%-13%; I2 = 27%), and 3% (95% CI, 1%-5%; I2 = 0%), respectively. The WPRs for EUS-based drainage for technical success, clinical success, postprocedure adverse events, and recurrent cholecystitis were 93% (95% CI, 87%-96%; I2 = 0%), 97% (95% CI, 93%-99%; I2 = 0%), 13% (95% CI, 8%-19%; I2 = 0%), and 4% (95% CI, 2%-9%; I2 = 0%), respectively. On proportionate difference, EUS-based drainage had better technical (10%) and clinical success (4%) in comparison with ERC-based drainage. The pooled OR for technical success of EGBD versus PGBD was .51 (95% CI, .09-2.88; I2 = 23%) and for postprocedure adverse events was .33 (95% CI, .14-.80; I2 = 16%) in favor of EGBD. Conclusions EGBD is an efficacious and safe therapeutic modality for treatment of patients with acute cholecystitis who cannot undergo surgery. EGBD shows a similar technical success as PGBD but appears to be safer than PGBD.
Background Benign biliary strictures (BBS) have been endoscopically managed with placement of multiple plastic stents. Uncovered metal stents have been associated with mucosal hyperplasia and ...partially covered self-expandable metal stents with migration. Recently, fully covered self-expandable metal stents (CSEMSs) with anchoring fins have become available. Objective Our purpose was to analyze the efficacy and complication rates of CSEMSs in the treatment of BBS. Design CSEMSs (10-mm diameter) were placed in 44 patients with BBS. CSEMSs were left in place until adequate biliary drainage was achieved, confirmed by resolution of symptoms, normalization of liver function tests, and imaging. Setting Tertiary care center with long-standing experience with metal stents. Patients A total of 44 patients with BBS (28 men, median age 53.5 years) were included. The preprocedure diagnoses included chronic pancreatitis (n = 19), gallstone-related strictures (n = 14), post liver transplant (n = 9), autoimmune pancreatitis (n = 1), and primary sclerosing cholangitis (n = 1). Intervention ERCP with temporary CSEMS placement. Removal of CSEMSs was performed with a snare or rat tooth. Main Outcome Measurements Stricture resolution and morbidity. Results The median time of CSEMS placement was 3.3 months (interquartile range 3.0-4.8). Resolution of the BBS was confirmed in 34 of 41 patients (83%) after a median postremoval follow-up time of 3.8 months (interquartile range 1.2-7.7). Complications were observed in 6 (14%) patients after CSEMS placement and in 4 (9%) after CSEMS removal. Limitation Pilot study from a single center. Conclusion Temporary placement of CSEMSs for BBS may offer an alternative to plastic stenting. Further investigation is required to further assess safety and long-term efficacy.
