Endoscopic Versus Surgical Treatment for Ampullary Lesions: A Systematic Review With Meta-Analysis.

Ampullary lesions (ALs) can be treated through either an endoscopic approach (EA) or a surgical approach (SA). However, it is important to note that EAs carry a significant risk of incomplete resection, while opting for surgical interventions can result in substantial morbidity. We performed a systematic review and meta-analysis for R0 resection, recurrence, adverse events in general, major adverse events, mortality, and length of hospital stay between SAs and EAs. Electronic databases were searched from inception to 2023. We identified nine independent studies. The risk difference was -0.32 (95% CI: -0.50, -0.15; p <0.001) for R0, 0.12 (95% CI: 0.06, 0.19; p < 0.001) for recurrence, -0.22 (95% CI: -0.43, 0.00; p 0.05) for overall adverse events, -0.11 (95% CI: -0.32, 0.10; p = 0.31) for major complications, -0.01 (95% CI: -0.02, 0.01; p = 0.43) for mortality, and -14.69 (95% CI: -19.91, -9.47; p < 0.001) for length of hospital stay. As expected, our data suggest a higher complete resection rate and lower recurrence from surgical interventions, but this is associated with an elevated risk of adverse events and a longer hospital stay.

Patient-Related Factors Associated With Long-Term Outcomes After Successful Endoscopic Balloon Dilation For Crohn's Disease-Associated Ileo-Colic Strictures: A Systematic Review and Meta-analysis.

Background: Successful Crohn's disease (CD) therapy relies on timely and precise management strategies. Endoscopic balloon dilation (EBD) has been applied as a first-line treatment for symptomatic CD-associated strictures due to its minimally invasive nature and the possibility of preserving intestinal length. Objective: The aim of the present study was to determine patient-related predictive factors associated with the need for surgery for CD-associated ileocolic strictures after technically successful EBD. Methods: All original studies published before December 2023 that reported the outcomes of patients treated with EBD for ileocolic strictures secondary to CD and described follow-up for at least 1 year were included. The difference in risk of needing surgery was calculated for 8 different patient characteristics (Sex, smoking habit, previous surgery, biologic therapy, steroids, immunosuppressors, nature of the stricture, and endoscopic disease activity). Results: There were significant differences in the risk of needing surgery after EBD among patients who underwent surgery and patients without a history of surgery (RD: -0.20 [-0.31, -0.08]), patients with endoscopic mucosal activity and patients in remission at the time of EBD (RD: 0.19 [0.04, 0.34]), patients using biologics at the time of EBD and patients not using biologics (RD: -0.09 [-0.16, -0.03]), and patients using steroids and those not using steroids at the time of EBD (RD: 0.16 [0.07, 0.26]). Conclusions: The use of biologics and endoscopic disease remission at the time of EBD were protective factors against the need for surgery. No previous surgery or use of steroids at the time of EBD was associated with the need for surgery during follow-up.

Effectiveness and Safety of the Allurion Swallowable Intragastric Balloon for Short-term Weight Loss: A Systematic Review and Meta-analysis.

BACKGROUND: Obesity poses a severe health problem worldwide, with an estimated impact on 17.5% of the adult population by 2035. Among the endoscopic applications for treating this comorbidity, intragastric balloons are the most widely used. The new liquid-filled swallowable balloon meets the requirements of major guidelines and allows significant weight loss with few adverse events. This systematic review and meta-analysis aims to demonstrate the efficacy and safety profile of this new device for weight loss. METHODS: We conducted a search from 2016 to 2024 to assess the efficacy of the swallowable intragastric balloon for weight loss, including improvements in metabolic profiles and anthropometric measurements. Additionally, we evaluated potential adverse events related to the device to demonstrate its safety. RESULTS: Eleven observational studies totalling 2107 patients were included, showing a reduction of 4.75 in BMI (95% CI: -5.02; -4.47), a mean total weight loss of 12.47% (95% CI: -13.77; -11.17), a mean excess weight loss of 48.04% (95% CI: -50.61; -45.48), and a rate of serious adverse events of 0.90%. An improvement in the metabolic profile was observed for three parameters: HDL, triglycerides, and glycaemia. CONCLUSION: The swallowable liquid-filled intragastric balloon is safe and effective for managing weight loss within a four-month follow-up period.

Pure cut vs. Endocut in endoscopic biliary sphincterotomy: Systematic review and meta-analysis of randomized clinical trials.

Background and study aims Biliary sphincterotomy is a crucial step in endoscopic retrograde cholangiopancreatography (ERCP), a procedure known to carry a 5% to 10% risk of complications. The relationship between Pure cut, Endocut, post-ERCP pancreatitis (PEP) and bleeding is unclear. This systematic review and meta-analysis compared these two current types and their relationships with adverse events. Patients and methods This systematic review involved searching articles in multiple databases until August 2023 comparing pure cut versus Endocut in biliary sphincterotomy. The meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Results A total of 987 patients from four randomized controlled trials were included. Overall pancreatitis: A higher risk of pancreatitis was found in the Endocut group than in the Pure cut group ( P =0.001, RD=0.04 [range, 0.01 to 0.06]; I 2 =29%). Overall immediate bleeding: Statistical significance was found to favor Endocut, ( P =0.05; RD=-0.15 [range, -0.29 to -0.00]; I 2 =93%). No statistical significance between current modes was found in immediate bleeding without endoscopic intervention ( P =0.10; RD=-0.13 [range, -0.29 to 0.02]; I 2 =88%), immediate bleeding with endoscopic intervention ( P =0.06; RD=-0.07 [range, -0.14 to 0.00]; I 2 =76%), delayed bleeding (P=0.40; RD=0.01 [range, -0.02 to 0.05]; I 2 =72%), zipper cut ( P =0.58; RD=-0.03 [range, -0.16 to 0.09]; I 2 =97%), perforation ( P =1.00; RD=0.00 [range, -0.01 to 0.01]; I 2 =0%) and cholangitis ( P =0.77; RD=0.00 [range, -0.01 to 0.02]; I 2 =29%). Conclusions The available data in the literature show that Endocut carries an increased risk for PEP and does not prevent delayed or clinically significant bleeding, although it prevents intraprocedural bleeding. Based on such findings, Pure cut should be the preferred electric current mode for biliary sphincterotomy.

Invasive Therapeutic Strategies for Stricturing Crohn's Disease in Childhood: A Systematic Review and Meta-Analysis.

BACKGROUND: Crohn's disease (CD) is a chronic inflammatory condition of the gastrointestinal tract. Current drugs are not effective for treating the primary fibrotic component of CD. Recommended invasive treatments include endoscopic balloon dilation, surgery with resection, or strictureplasty. This meta-analysis compared invasive treatment techniques for CD-related strictures in the pediatric population. METHODS: The MEDLINE, EMBASE, and LILACS databases were searched from inception to December 2023. This meta-analysis was performed as per the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The outcome was measured by the rate of stenosis recurrence and the adverse events of the techniques. Eligibility criteria were studies that involved the analysis of the recurrence rate of stenosis in pediatric patients with CD requiring surgical intervention after undergoing any of the previously proposed therapies. Additionally, adverse events were analyzed. RESULTS: Three studies comprising a total of 106 endoscopic balloon dilations demonstrated a combined rate of stricture recurrence in patients with CD requiring surgical intervention of 0.171 (95% confidence interval [CI], 0.110-0.255). Three studies comprising a total of 49 surgical resections demonstrated a pooled event rate of 0.100 (95% CI, 0.038-0.240). Finally, 2 studies comprising a total of 38 strictureplasties demonstrated a pooled event rate of 0.347 (95% CI, 0.070-0.789). Concerning adverse events, the most common occurrences were found after surgical resection. CONCLUSIONS: Surgical resection is the best option for treating strictures in pediatric CD patients in terms of recurrence rate, compared with endoscopic balloon dilation and strictureplasty. Nevertheless, surgical resection is associated with more adverse events.

This meta-analysis compares techniques for pediatric Crohn's disease­related strictures. Surgical resection, compared with balloon dilation or strictureplasty, is the best option for treating strictures in these patients in terms of recurrence rate but is associated with more adverse events.

Endoscopic transoral outlet reduction induces enterohormonal changes in patients with weight regain after Roux-en-Y gastric bypass.

Background and study aims Transoral outlet reduction (TORe) has long been employed in treating weight regain after Roux-en-Y gastric bypass. However, its impact on gut hormones and their relationship with weight loss remains unknown. Patients and methods This was a substudy of a previous randomized clinical trial. Adults with significant weight regain and dilated gastrojejunostomy underwent TORe with argon plasma coagulation (APC) alone or APC plus endoscopic suturing (APC-suture). Serum levels of ghrelin, GLP-1, and PYY were assessed at fasting, 30, 60, 90, and 120 minutes after a standardized liquid meal. Results were compared according to allocation group, clinical success, and history of cholecystectomy. Results Thirty-six patients (19 APC vs. 17 APC-suture) were enrolled. There were no significant baseline differences between groups. In all analyses, the typical postprandial decrease in ghrelin levels was delayed by 30 minutes, but no other changes were noted. GLP-1 levels significantly decreased at 12 months in both allocation groups. Similar findings were noted after dividing groups according to the history of cholecystectomy and clinical success. The APC cohort presented an increase in PYY levels at 90 minutes, while the APC-suture group did not. Naïve patients had significantly lower PYY levels at baseline ( P = 0.01) compared with cholecystectomized individuals. This latter group experienced a significant increase in area under the curve (AUC) for PYY levels, while naïve patients did not, leading to a higher AUC at 12 months ( P = 0.0001). Conclusions TORe interferes with the dynamics of gut hormones. APC triggers a more pronounced enteroendocrine response than APC-suture, especially in cholecystectomized patients.

Correction: Intraductal radiofrequency ablation plus biliary stent versus stent alone for malignant biliary obstruction: a systematic review and meta-analysis.

[This corrects the article DOI: 10.1055/a-2204-8316.].

Radiofrequency ablation for ampullary neoplasia with intraductal extension after endoscopic papillectomy: Systematic review and meta-analysis.

Background and study aims Noninvasive ampullary neoplasms may be removed by surgery or endoscopy. However, given the morbidity and mortality associated with surgery, endoscopic papillectomy (EP) is the preferred approach. Radiofrequency ablation (RFA) after EP has emerged as a promising alternative therapy to avoid surgery after incomplete EP. Our goal was to evaluate the efficacy and safety of RFA for residual or recurrent lesions with intraductal extension after endoscopic papillectomy. Patients and methods The inclusion criteria include clinical trials, cohort studies, and case series evaluating patients with residual or recurrent lesions with intraductal extension after EP treated with RFA. Case reports, duplicated data, and studies with follow-up periods < 10 months were excluded. The metanalysis evaluated adverse events, surgical conversion rate, clinical success and recurrence. Results Seven studies were selected, totaling 124 patients. RFA was associated with a clinical success rate of 75.7% (95% confidence interval [CI] 65.0-88.0%; I 2 = 23.484) in a mean follow-up period < 10 months. However, the biliary stricture rate was 22.2% (95% CI 12.1-28.4%; I 2 = 61.030), 14.3% of pancreatitis (95% CI 8.8-22.3%; I 2 < 0.001), 7.0% of cholangitis (95% CI 3.3-14.5%; I 2 < 0.001), 4.0% of bleeding (95% CI 1.7-9.3%; I 2 < 0.001), and recurrence of 24.3% (95% CI 16.0-35.0%; I 2 = 23.484). Conclusions RFA is feasible and appears to be effective for managing residual or recurrent lesions with intraductal extension after EP. However, long-term follow-up and high-quality studies are required to confirm our findings.

Intraductal radiofrequency ablation plus biliary stent versus stent alone for malignant biliary obstruction: a systematic review and meta-analysis.

Background and study aims Recurrent biliary stent occlusion and tumor ingrowth remain a major concern among patients with malignant biliary obstruction (MBO) with significant impact on patient morbidity and survival. Intraductal radiofrequency ablation (RFA) has emerged as a promising treatment that seeks to extend stent patency. This study aimed to evaluate the impact of RFA on overall survival (OS) and stent patency among patients with unresectable MBO. Methods A comprehensive search of electronic databases was performed for randomized controlled trials (RCTs) comparing RFA plus biliary stent (RFA+S) versus biliary stent alone (S-alone). Outcomes assessed included overall survival, stent patency, and adverse events (AEs) with mean difference (MD) calculated from pooled proportions. Subgroup analyses were performed for hilar strictures and cholangiocarcinoma (CCA). Results Six RCTs (n=439 patients) were included and demonstrated improved survival among patients who received RFA+S (MD 85.80 days; 95% confidence interval [CI] 35.02-136.58; I 2 =97%; P <0.0009). The pooled MD for total stent patency was 22.25 days (95% CI 17.38-61.87; I 2 =97%; P =0.27). There was no difference in AEs between RFA+S vs S-alone ( P >0.05). On subgroup analyses, RFA+S was associated with improved stent patency (MD 76.73 days; 95% CI 50.11-103.34; I 2 =67%; P <0.01) and OS (MD 83.14 (95% CI 29.52-136.77; I 2 =97%; P <0.01] for CCA. For hilar strictures, stent patency was improved among patients with RFA+S [MD 83.71 days (95% CI 24.85-142.56; I 2 =84%; P <0.01]. Conclusions RFA+S improved OS in the treatment of MBO when compared with S-alone. Moreover, the RFA therapy prolonged stent patency in hilar strictures and CCA, with similar rates of AEs.

Cryotherapy versus radiofrequency ablation in the treatment of dysplastic Barrett's esophagus with or without early esophageal neoplasia: a systematic review and meta-analysis.

BACKGROUND/AIMS: Radiofrequency ablation (RFA) is the first-line therapy for dysplastic Barrett's esophagus (BE). Therefore, cryotherapy has emerged as an alternative treatment option. This study aimed to compare the efficacies of these two techniques based on the rates of complete eradication of intestinal metaplasia (CE-IM) and dysplasia (CE-D). Adverse events and recurrence have also been reported. METHODS: An electronic search was conducted using the Medline (PubMed), Embase, LILACS, and Google Scholar databases until December 2022. Studies were included comparing cryotherapy and RFA for treating dysplastic BE with or without early esophageal neoplasia. This study was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Three retrospective cohort studies involving 627 patients were included. Of these, 399 patients underwent RFA, and 228 were treated with cryotherapy. There was no difference in CE-IM (risk difference [RD], -0.03; 95% confidence interval [CI], -0.25 to 0.19; p=0.78; I2=86%) as well as in CE-D (RD, -0.03; 95% CI, -0.15 to 0.09; p=0.64; I2=70%) between the groups. The absolute number of adverse events was low, and there was no difference in the recurrence rate. CONCLUSION: Cryotherapy and RFA were equally effective in treating dysplastic BE, with or without early esophageal neoplasia.

Endoscopic ultrasound artificial intelligence-assisted for prediction of gastrointestinal stromal tumors diagnosis: A systematic review and meta-analysis.

BACKGROUND: Subepithelial lesions (SELs) are gastrointestinal tumors with heterogeneous malignant potential. Endoscopic ultrasonography (EUS) is the leading method for evaluation, but without histopathological analysis, precise differentiation of SEL risk is limited. Artificial intelligence (AI) is a promising aid for the diagnosis of gastrointestinal lesions in the absence of histopathology. AIM: To determine the diagnostic accuracy of AI-assisted EUS in diagnosing SELs, especially lesions originating from the muscularis propria layer. METHODS: Electronic databases including PubMed, EMBASE, and Cochrane Library were searched. Patients of any sex and > 18 years, with SELs assessed by EUS AI-assisted, with previous histopathological diagnosis, and presented sufficient data values which were extracted to construct a 2 × 2 table. The reference standard was histopathology. The primary outcome was the accuracy of AI for gastrointestinal stromal tumor (GIST). Secondary outcomes were AI-assisted EUS diagnosis for GIST vs gastrointestinal leiomyoma (GIL), the diagnostic performance of experienced endoscopists for GIST, and GIST vs GIL. Pooled sensitivity, specificity, positive, and negative predictive values were calculated. The corresponding summary receiver operating characteristic curve and post-test probability were also analyzed. RESULTS: Eight retrospective studies with a total of 2355 patients and 44154 images were included in this meta-analysis. The AI-assisted EUS for GIST diagnosis showed a sensitivity of 92% [95% confidence interval (CI): 0.89-0.95; P < 0.01), specificity of 80% (95%CI: 0.75-0.85; P < 0.01), and area under the curve (AUC) of 0.949. For diagnosis of GIST vs GIL by AI-assisted EUS, specificity was 90% (95%CI: 0.88-0.95; P = 0.02) and AUC of 0.966. The experienced endoscopists' values were sensitivity of 72% (95%CI: 0.67-0.76; P < 0.01), specificity of 70% (95%CI: 0.64-0.76; P < 0.01), and AUC of 0.777 for GIST. Evaluating GIST vs GIL, the experts achieved a sensitivity of 73% (95%CI: 0.65-0.80; P < 0.01) and an AUC of 0.819. CONCLUSION: AI-assisted EUS has high diagnostic accuracy for fourth-layer SELs, especially for GIST, demonstrating superiority compared to experienced endoscopists' and improving their diagnostic performance in the absence of invasive procedures.

High frequency of gastrointestinal complaints, but insignificant prevalence of gluten-sensitive enteropathies in Brazilian fibromyalgia patients.

INTRODUCTION/OBJECTIVES: Coeliac disease (CD) and non-coeliac gluten sensitivity (NCGS) cause symptoms like those seen in patients with fibromyalgia (FM) and functional gastrointestinal disorders. There is no consistent data on frequency of these symptoms and no study performed duodenal biopsies to investigate CD/NCGS in Brazilian FM patients. Therefore, we sought to verify the prevalence of CD/NCGS in FM patients and the association between gastrointestinal manifestations and FM symptoms. MATERIAL AND METHODS: Sixty-two individuals with FM (ACR2010) were recruited from FM outpatient clinics of a tertiary hospital. Clinical evaluation included the Widespread Pain Index (WPI), Severity Symptom Scale (SS), Polysymptomatic Distress Scale (PDS), and Fibromyalgia Impact Questionnaire (FIQ). Subjects were screened for the presence of coeliac antibodies and upper gastrointestinal endoscopy (duodenal biopsies) was performed for diagnosis of CD/NCGS. RESULTS: 46 (74.2%) women reported at least one digestive symptom: constipation, abdominal distension, loss of weight/inappetence, and nausea/vomiting. Fourteen (31.8%) presented macroscopic duodenitis and 2(4.5%) had duodenal lymphocytic infiltrates, but none met CD criteria. In 1(1.6%) patient NCGS was confirmed. There was association between presence of any digestive symptom and WPI and SS (fatigue, waking up tired, cognition), but no difference on FIQ between patients with and without gastrointestinal symptoms. CONCLUSION: Gastrointestinal complaints were frequent and associated with increased degree of polysymptomatic distress in FM patients, but presence of these symptoms was not related to overall impact of FM over different dimensions of the patient's life. Moreover, the prevalence of CD/NCGS was very low. This suggests that screening for CD in Brazilian FM patients might not be cost-effective, since the frequency of CD/NCGS was very low.

Impact of Endoscopic Sleeve Gastroplasty in Non-alcoholic Fatty Liver Disease: a Systematic Review and Meta-analysis.

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of liver disease worldwide. Endoscopic sleeve gastroplasty (ESG) has proven to be feasible, safe, and effective in the management of obesity. We performed the first systematic review and meta-analysis evaluating NAFLD and other metabolic parameters 12 months post-ESG. Four observational studies with a total of 175 patients were included. The results showed a significant (p < 0.05) reduction of 4.85 in hepatic steatosis index (95% CI - 6.02, - 3.67), 0.5 in NAFLD fibrosis score (95% CI - 0.80, - 0.19), 6.32 U/l in ALT (95% CI - 9.52, - 3.11), 17.28% in TWL (95% CI - 18.24, - 16.31), 6.31 kg/m2 in BMI (95% CI - 8.11, - 4.52), 47.97% in EWL (95% CI - 49.10, - 46.84), and 0.51% in HbA1c (95% CI - 0.90, - 0.12). ESG improves liver parameters, provides weight loss, and reduces HbA1c levels in patients suffering from NAFLD.

Fecal microbiota transplantation in patients with metabolic syndrome and obesity: A randomized controlled trial.

BACKGROUND: Metabolic syndrome is a multifactorial disease, and the gut microbiota may play a role in its pathogenesis. Obesity, especially abdominal obesity, is associated with insulin resistance, often increasing the risk of type two diabetes mellitus, vascular endothelial dysfunction, an abnormal lipid profile, hypertension, and vascular inflammation, all of which promote the development of atherosclerotic cardiovascular disease. AIM: To evaluate the outcomes of fecal microbiota transplantation (FMT) in patients with metabolic syndrome. METHODS: This was a randomized, single-blind placebo-controlled trial comparing FMT and a sham procedure in patients with metabolic syndrome. We selected 32 female patients, who were divided into eight groups of four patients each. All of the patients were submitted to upper gastrointestinal endoscopy. In each group, two patients were randomly allocated to undergo FMT, and the other two patients received saline infusion. The patients were followed for one year after the procedures, during which time anthropometric, bioimpedance, and biochemical data were collected. The patients also had periodic consultations with a nutritionist and an endocrinologist. The primary end point was a change in the gut microbiota. RESULTS: There was evidence of a postprocedural change in microbiota composition in the patients who underwent FMT in relation to that observed in those who underwent the sham procedure. However, we found no difference between the two groups in terms of the clinical parameters evaluated. CONCLUSION: There were no significant differences in biochemical or anthropometric parameters, between the two groups evaluated. Nevertheless, there were significant postprocedural differences in the microbiota composition between the placebo group. To date, clinical outcomes related to FMT remain uncertain.

Pseudotumoral Amyloidosis Presentation With Upper Digestive Bleeding.

Amyloidosis is a condition related to the extracellular deposition of abnormal fibrillar proteins. Gastric involvement may present as a systemic or localized form of the disease. The endoscopic presentation can vary from nodular, ulcerated, or infiltrative lesions. Clinical manifestations are nonspecific, including hyporexia, nausea, vomiting, weight loss, epigastralgia, and abdominal discomfort. Thus, amyloidosis can clinically and endoscopically mimic other diseases, such as neoplasms, syphilis, tuberculosis, and Crohn's disease, requiring a high suspicion. When it manifests with gastrointestinal bleeding, it most commonly occurs as intermittent melena. This report aims to present an unusual case of a patient with upper gastrointestinal bleeding exteriorized through melena secondary to amyloidosis with gastric involvement.

A Head-to-Head Comparison of Computed Tomography Colonography, Optical Colonoscopy, and Colon Endoscopic Capsule for the Detection of Polyps After Partial Colectomy or Rectosigmoidectomy for Colorectal Cancer: A Pilot Study.

Background and objective Optical colonoscopy is the gold standard method for the diagnosis of colorectal cancer (CRC) and it allows for biopsy and resection, as well as documentation of synchronous lesions. CT colonography (CTC) and colon endoscopic capsule (CEC) are also recommended as alternative minimally invasive or non-invasive procedures. Prospective studies comparing these three approaches are scarce in the current literature. In light of this, the aim of this pilot study was to compare the efficacy of polyp detection between these three methods in patients with a history of curative surgical resection of CRC. Methods Patients were consecutively recruited and all procedures were sequentially conducted on the same day. The primary endpoint was the detection rate of polyps, whereas secondary endpoints were the detection of polyps according to size and location, and the adverse events caused by these procedures. Results A total of 21 patients were consecutively included and all of them underwent all three interventions. No adverse events, local recurrences, or metachronous lesions were detected. In two cases with elevated carcinoembryonic antigen (CEA), CTC unveiled distant metastasis. Optical colonoscopy registered a mean of 0.4 polyp >6 mm and 1.3 polyps <6 mm per patient. CTC unveiled only 0.5 polyp >6 mm/patient and no smaller lesions were documented, whereas findings for the colon capsule comprised an average of 0.4 polyps >6 mm and 0.7 polyps <6 mm per patient. Statistical difference was not demonstrated, except for virtual colonoscopy in terms of the total number of polyps detected in comparison to optical colonoscopy. Conclusions Optical colonoscopy showed superior results in comparison to virtual colonoscopy while there was no statistical difference in comparison to colon capsule. Notwithstanding occasional difficulties, all three techniques were well tolerated. Hence, decisions concerning the use of each diagnostic method should be based on their availability, professional expertise, contraindications, and patient preferences.

Self-Expandable Metal Stent (SEMS) Versus Lumen-Apposing Metal Stent (LAMS) for Drainage of Pancreatic Fluid Collections: A Randomized Clinical Trial.

Background and aim Endoscopic ultrasound (EUS)-guided drainage is the gold standard approach for the treatment of encapsulated pancreatic collections (EPCs) including pseudocyst and walled-off pancreatic necrosis (WON), and is associated with an equivalent clinical efficacy to surgical drainage with fewer complications and less morbidity. Drainage may be achieved via several types of stents including a fully covered self-expandable metallic stent (SEMS) and lumen-apposing metal stent (LAMS). However, to date there have been no randomized trials to compare these devices. This study aimed to compare the efficacy and safety of the SEMS versus LAMS for EUS-guided drainage of EPCs. Methods A phase IIB randomized trial was designed to compare the SEMS versus LAMS for the treatment of EPCs. Technical success, clinical success, adverse events (AEs), and procedure time were evaluated. A sample size of 42 patients was determined. Results There was no difference between the two groups in technical (LAMS 80.95% vs 100% SEMS, p=0.107), clinical (LAMS 85.71% vs 95.24% SEMS, p=0.606) or radiological success (LAMS 92.86% vs 83.33% SEMS, p=0.613). There was no difference in AEs including stent migration rate and mortality. The procedure time was longer in the LAMS group (mean time 43.81 min versus 24.43 min, p=0.001). There was also a difference in the number of intra-procedure complications (5 LAMS vs 0 SEMS, p=0.048). Conclusion SEMS and LAMS have similar technical, clinical, and radiological success as well as AEs. However, SEMS has a shorter procedure time and fewer intra-procedure complications compared to non-electrocautery-enhanced LAMS in this phase IIB randomized controlled trial (RCT). The choice of the type of stent used for EUS drainage of EPCs should consider device availability, costs, and personal and local experience.