The addition of endoscopic sphincterotomy to biliary stent placement and its impact on the risk of adverse events: an updated meta-analysis of randomized controlled trials.

BACKGROUND AND AIMS: Endoscopic sphincterotomy (ES) is not mandatory before biliary stenting. The impact of ES before biliary stent placement remains uncertain. Previous studies have reported that ES can increase adverse event rates by up to 4.5 times compared with no ES. We aimed to assess the occurrence of post-ERCP adverse events following biliary stent placement with and without ES. METHODS: PubMed, Embase, and Cochrane databases were systematically searched for randomized controlled trials. The primary outcome was post-ERCP pancreatitis (PEP). Subgroup analyses were performed with patients undergoing biliary drainage due to obstruction, using metal stents, and using plastic stents. Secondary outcomes were postprocedural bleeding, perforation, stent/catheter occlusion, stent/catheter migration, and cholangitis. Heterogeneity was examined with I2 statistics, and a random-effects model was used. Review Manager 5.4 was used for statistical analyses. RESULTS: Seven RCTs with 1022 patients were included. There was no significant difference between the ES and non-ES groups (odds ratio [OR], .46; 95% CI, .19-1.09; P = .08; I2 = 59%) regarding PEP; however, a significant difference in bleeding rates was found between groups, favoring non-ES (OR, 7.01; 95% CI, 2.24-21.99; P = .0008; I2 = 0%). The analysis of the occurrence of cholangitis (OR, 1.25; 95% CI, .58-2.69; P = .56; I2 = 67%), perforation (OR, 1.95; 95% CI, .07-55.73; P = .70; I2 = 58%), stent/catheter migration (OR, 2.15; 95% CI, .61-7.57; P = 0.23; I2 = 6%), and stent/catheter occlusion (OR, .91; 95% CI, .37-2.25; P = .84; I2 = 0%) did not favor either group. CONCLUSIONS: Performing ES before biliary drainage does not affect the PEP rate but is associated with an increased postprocedural bleeding rate.

Role of Novel Motorized Enteroscopy in the Evaluation of Small Bowel Diseases: A Systematic Review and Meta-analysis.

BACKGROUND AND AIM: Motorized spiral enteroscopy (MSE) has recently been introduced for small bowel evaluation. In this systematic review and meta-analysis, we aim to evaluate the safety and efficacy of MSE for evaluation of small bowel diseases. METHODS: A literature search was performed in Embase, PubMed, Medline databases for studies evaluating MSE between January -2010 and October-2022. The primary outcome of the study was diagnostic yield with MSE. Secondary outcomes included technical success, procedure duration, depth of maximum insertion (DMI), rate of pan-enteroscopy and adverse events. RESULTS: 10 studies with 961 patients [581 (60.5%) males] were included in the analysis. 1068 MSE procedures were performed by antegrade route in 698, retrograde route in 215 and bidirectional in 155 patients. Technical success was achieved in 94.9% (95% CI 92.9% to 96.4%) procedures. The pooled diagnostic yield of MSE was 73.7% (95% CI 70.7% to 76.4%). Pooled rate of pan-enteroscopy by antegrade route was 21.9% (95% CI 18.1% to 26.1%), retrograde route was 6.9% (95% CI 2.4% to 18.3%) and combined route was 61.2% (95% CI 52.4% to 69.3%). Pooled rate of major adverse events was 1.9% (95% CI 1.2% to 3.2%). CONCLUSIONS: MSE is a safe and effective tool for evaluating small bowel disorders. High diagnostic yield and low rate of adverse events make it a potential alternative to balloon enteroscopy. However, comparative trials are required in the future.

EUS versus MRCP to perform ERCP in patients with intermediate likelihood of choledocholithiasis: a randomised controlled trial.

OBJECTIVE: In patients with an intermediate likelihood of choledocholithiasis, European Society of Gastrointestinal Endoscopy (ESGE) guidelines recommend endoscopic ultrasound (EUS) or magnetic resonance cholangiopancreatography (MRCP) to diagnose choledocholithiasis to make the indication for endoscopic retrograde cholangiopancreatography (ERCP) treatment; there is no randomised control trial to compare both in this setting. DESIGN: Patients with suspected choledocholithiasis satisfying ESGE guideline's intermediate likelihood were screened for this single-centre randomised controlled trial between November 2019 and May 2020. The enrolled patients were randomised to either EUS or MRCP. ERCP was performed in stone positive cases or if clinical suspicion persisted during follow-up. Negative cases underwent a further 6-month clinical follow-up. Main outcome was accuracy (sensitivity/specificity) of both tests to diagnose choledocholithiasis, with ERCP or follow-up as a gold standard. RESULTS: Of 266 patients, 224 patients (mean age: 46.77±14.57 years; 50.9 % female) were enrolled; overall prevalence of choledocholithiasis was 49.6%, with a higher frequency in the MRCP group (63/112 vs 46/112 for EUS). Both sensitivity of EUS and MRCP were similarly high (92%-98%), without significant differences between the two groups. The negative predictive value and likelihood ratio + were significantly higher in EUS arm (p<0.05). The percentage of ERCPs either incorrectly halted back (false negatives: EUS: 2 vs MRCP: 5) or performed unnecessarily (false positives: EUS: 1 vs MRCP: 2) was low in both groups. CONCLUSION: The performance parameters of both EUS and MRCP are comparable for detecting choledocholithiasis in the intermediate-risk group of choledocholithiasis and the choice of a test should be based on local expertise, availability of resources and patient preference. TRIAL REGISTRATION NUMBER: NCT04173624.

Impact of transmural plastic stent on recurrence of pancreatic fluid collection after metal stent removal in disconnected pancreatic duct: a randomized controlled trial.

BACKGROUND: Disconnected pancreatic duct (DPD) after development of walled-off necrosis (WON) predisposes to recurrent (peri)pancreatic fluid collection (PFC). In this randomized controlled trial, we compared plastic stents with no plastic stent after removal of a large-caliber metal stent (LCMS) on incidence of recurrent PFCs in DPD. METHODS : Consecutive patients with WON who underwent endoscopic ultrasound (EUS)-guided drainage with LCMS between September 2017 and March 2020 were screened for eligibility. At LCMS removal (4 weeks after drainage), patients with DPD were randomized to plastic stent or no stent groups. The primary outcome was incidence of recurrent PFC at 3 months. Secondary outcomes were technical success of plastic stent deployment, adverse events, stent migration, and recurrence of PFC at 6 and 12 months. RESULTS: 236 patients with WON underwent EUS-guided drainage using LCMS, and 104 (males 94, median age 34 years (interquartile range [IQR] 26-44.7) with DPD were randomized into stenting (n = 52) and no-stenting (n = 52) groups. Plastic stent deployment was successful in 88.5 %. Migration occurred in 19.2 % at median follow-up of 8 months (IQR 2.5-12). Recurrent PFCs occurred in six patients at 3 months (stent n = 3, no stent n = 3). There was no significant difference in PFC recurrence between the two groups at 3, 6, and 12 months. Reintervention was required in seven patients with recurrent PFCs, with no significant difference between the two groups. CONCLUSION: In patients with WON and DPD, deployment of plastic stents after LCMS removal did not reduce recurrence of PFC.

Outcomes of Per-Oral Endoscopic Myotomy in Children: A Systematic Review and Meta-analysis.

Per-oral endoscopic myotomy (POEM) is an established treatment modality in adult patients with achalasia cardia. There are limited data regarding the efficacy and safety of POEM in pediatric achalasia. In this systematic review and meta-analysis, we aimed to analyze the outcomes of POEM in children and adolescents with achalasia cardia. Literature search was performed in Embase, PubMed, and Cochrane database for studies evaluating the outcome of POEM in pediatric achalasia between January 2010 and March 2021. Primary objective of the study was clinical success (Eckardt ≤ 3). Secondary outcomes included technical success, procedure duration, adverse events , and gastroesophageal reflux after POEM. A total of 14 studies (419 children, 234 boys) were included in the review. The subtypes of achalasia were type I (30.6%), type II (63.8%), and type III (5.6%). Pooled rate of technical success was 97.1% (95% CI 94.5-98.5%; I2 = 0). Pooled clinical success in intention to treat and per-protocol population was 88% (95% CI 84.4-90.9%; I2 = 0) and 94.4% (95% CI 91.5-96.4%; I2 = 0), respectively. Post-POEM, pooled mean reduction in Eckardt scores was 6.71 (95% CI 6.14 7.28; p < 0.001; I2 = 81%). Pooled rate for overall adverse events was 12.9% (95% CI 7.4-21.7%; I2 64.5%), major adverse events was 4.2% (95% CI 2.4-7.4%), and erosive esophagitis was 26.3% (95% CI 17.5-37.7%; I2 51%). POEM is an effective procedure in children with achalasia. Future studies are required to determine the durability of response and comparative outcomes with other treatment modalities for achalasia.

Per-oral Endoscopic Myotomy with Division of Septum (D-POEM) in Epiphrenic Esophageal Diverticula: Outcomes at a Median Follow-Up of Two Years.

Esophageal epiphrenic diverticula (EED) are rare pulsion-type outpouchings at the lower end of esophagus. Traditionally, surgery has been performed in EED. More recently, per-oral endoscopic myotomy with septotomy (D-POEM) has emerged as an option in these cases. In this study, we aim to determine the efficacy and safety of D-POEM in cases with EED. The data of cases who underwent D-POEM in cases with EED from March 2013 to Nov 2020 were analyzed, retrospectively. The primary outcome of the study was clinical success. Secondary outcomes included technical success, procedure duration, reflux esophagitis, and adverse events. 13 patients (males 9, 48.07 ± 17.55 years) with EED underwent D-POEM during the study period. Median size of the EED was 45 mm (range 25-70). Associated esophageal motility disorder was found in 10 (76.9%) cases including type II achalasia (3), type I (3), hypercontractile esophagus (2), and unspecified (2). Technical success was achieved in 12 (92.3%) cases. Median length of total and gastric myotomies were 10 cm (range 6-20) and 3 cm (1-3), respectively. At a median follow-up of 25 months, clinical success was achieved in 84.6% cases. Mean integrated relaxation pressures reduced significantly after POEM procedure (25.80 ± 13.24 vs 9.40 ± 3.10, p = 0.001). There was one major adverse event requiring surgical intervention. D-POEM is an effective procedure in cases with EED. Long-term follow-up studies are required to ascertain the durability of response in these cases.

Long-term Outcomes of Per-oral Endoscopic Myotomy in Spastic Esophageal Motility Disorders: A Large, Single-Center Study.

BACKGROUND AND AIMS: Spastic esophageal motility disorders (SEMD) are a rare group of motility disorders including type III achalasia, distal esophageal spasm (DES), and Jackhammer esophagus (JHE). Limited data suggest that per-oral endoscopic myotomy (POEM) may be effective in these disorders. In this study, we aimed to evaluate the long-term outcomes of POEM in SEMD. METHODS: The data of patients with SEMD who underwent POEM (January 2013 to December 2019) were analyzed, retrospectively. The following outcomes were recorded: POEM procedure details, technical and clinical success, adverse events, and gastroesophageal reflux disease (GERD). Clinical success was classified as immediate (<1 y), short-term (1 to 3 y), medium term (3 to 5 y), and long-term (>5 y). RESULTS: A total of 1115 POEM procedures were performed during the study period for achalasia and nonachalasia spastic motility disorders. POEM was performed for SEMD in 74 (6.6%) patients including type III in 53, DES in 11, and JHE in 10 patients. Technical success was achieved in all the patients. The median follow-up for the entire group was 47.5 months (range: 2 to 77 mo). Clinical success at short-term (1 to 3 y) and long-term follow-up (>5 y) was attained in 85.2% and 82.6% patients, respectively. There was no significant difference in the clinical success between type III achalasia and JHE/DES. Mild and moderate adverse events were recorded in 21 (28.4%) cases. GERD was detected in 23 (56.1%) patients with 24-hour pH study. Erosive esophagitis and symptomatic GERD were found in 36 (48.6%) and 16 (21.6%) patients, respectively. CONCLUSIONS: POEM is a safe, effective, and durable treatment modality for spastic motility disorders of the esophagus. However, GERD is found in about half of the patients mandating close monitoring after POEM.

Clinical utility of ESGE and ASGE guidelines for prediction of suspected choledocholithiasis in patients undergoing cholecystectomy.

BACKGROUND: Recent guidelines from the European Society of Gastrointestinal Endoscopy (ESGE) and American Society for Gastrointestinal Endoscopy (ASGE) recommend risk stratification according to liver function test (LFT) and abdominal ultrasound in patients with suspected choledocholithiasis. We evaluated and validated the clinical utility of these new risk stratification criteria for choledocholithiasis. METHODS: We retrospectively analyzed prospectively maintained data of patients with suspected choledocholithiasis between January 2016 and December 2018 in patients undergoing cholecystectomy. Patients with common bile duct stricture, cirrhosis, and portal biliopathy were excluded. After LFT and ultrasound, all patients were stratified according to ESGE and ASGE criteria into high, intermediate, and low likelihood of choledocholithiasis. RESULTS: 1042 patients were analyzed. Using ESGE guidelines, 213 patients (20.4 %) met high likelihood criteria, 637 (61.1 %) met intermediate, and 192 (18.4 %) met low likelihood criteria. Using ASGE guidelines, 230 (22.1 %), 678 (65.1 %), and 134 (12.9 %) met high, intermediate, and low likelihood criteria, respectively. Specificity and positive predictive value (PPV) of ASGE high likelihood criteria were 96.87 % (95 % confidence interval [CI] 95.37 - 97.98) and 89.57 % (95 %CI 85.20 - 92.75) for choledocholithiasis compared with 98.96 % (95 %CI 97.95 - 99.55) and 96.24 % (95 %CI 92.76 - 98.09), respectively, for ESGE criteria. ASGE classified 17 (7.4 %) additional patients as high likelihood compared with ESGE, only one of whom had choledocholithiasis. ASGE classified 58 (8.6 %) additional patients as intermediate, none of whom had choledocholithiasis. CONCLUSION: This study validates the clinical utility of new ESGE and ASGE criteria for predicting choledocholithiasis. ESGE risk stratification appears more specific than ASGE.

API-ISG Consensus Guidelines for Management of Gastrooesophageal Reflux Disease.

Gastroesophageal reflux disease (GERD) is a common problem in the community. The Indian Society of Gastroenterology and Association of Physicians of India have developed this evidence-based practice guideline for management of GERD in adults. A modified Delphi process was used to develop this consensus containing 43 statements, which were generated by electronic voting iteration as well as face-to-face meeting, and review of the supporting literature primarily from India. These statements include 4 on epidemiology, 9 on clinical presentation, 11 on investigations, 18 on treatment (including medical, endoscopic, and surgical modalities), and one on complications of GERD. The statement was regarded as accepted when the proportion of those who voted either to accept completely or with minor reservation was 80% or higher. The prevalence of GERD in large population-based studies in India is approximately 10% and is probably increasing due to lifestyle changes and increase in obesity. The diagnosis of GERD in the community should be mainly based on presence of classical symptoms like heartburn and sour regurgitation, and empiric treatment with a proton pump inhibitor (PPI) or H2 receptor antagonist should be given. All PPIs in equipotent doses are similar in their efficacy in the management of symptoms. Patients in whom symptoms do not respond adequately to PPI are regarded as having PPIrefractory GERD. Invasive investigations should be limited to patients with alarm symptoms and those with refractory GERD.

Outcome of peroral endoscopic myotomy in children with achalasia.

BACKGROUND AND AIMS: Achalasia cardia is rare in children and optimum endoscopic management options are not well known. Peroral endoscopic myotomy (POEM) is a novel treatment modality for achalasia with excellent results in adult patients. The long-term outcomes of POEM are not well known in children. In this study, we aim to evaluate the outcome of POEM in children with idiopathic achalasia. METHODS: We analyzed the data of children (≤ 18 years) diagnosed with achalasia from September 2013 to January 2018. Technical success, clinical success, and adverse events were assessed. Post-POEM, gastroesophageal reflux (GER) was assessed with 24-h pH-impedance study and esophagogastroduodenoscopy. RESULTS: A total of 44 children (boys-23, girls-21) with mean age of 14.5 ± 3.41 years (4-18) were diagnosed with achalasia during the study period. Of these, 43 children underwent POEM. The subtypes of achalasia according to Chicago classification were type I-11, type II-29, type III-2, and unclassified-2. Eighteen children (40.9%) had history of prior treatment. POEM was successfully performed in 43 children (technical success-97.72%). Intra-operative adverse events occurred in 11 (25.6%) children including retroperitoneal CO2 (7), capnoperitoneum (3), and mucosal injury (1). Clinical success at 1, 2, 3, and 4 years' follow-up was 92.8%, 94.4%, 92.3%, and 83.3%, respectively. Erosive esophagitis was detected in 55% (11/20) children. On 24-h pH study, GER was detected in 53.8% (7/13) children. CONCLUSION: POEM is a safe, effective, and durable treatment for achalasia in children. However, GER is a potential concern and should be evaluated in prospective studies before adopting POEM for the management of achalasia in children.

Peroral endoscopic myotomy in treatment-naïve achalasia patients versus prior treatment failure cases.

BACKGROUND AND STUDY AIM: Peroral endoscopic myotomy (POEM) has emerged as an effective treatment modality for achalasia. Prior treatment may affect the outcomes of subsequent management. In this study, we aimed to compare the safety and efficacy of POEM in treatment-naïve patients vs. those with prior treatment failure (PTF). PATIENTS AND METHODS: The data of consecutive patients with achalasia who underwent POEM at a single tertiary care center from January 2013 to November 2016 were analyzed retrospectively. A comparative analysis was performed between treatment-naïve and PTF cases. Technical and clinical success, adverse events, and operative time for POEM were compared between the two groups. RESULTS: Overall, 502 patients with achalasia underwent POEM during the study period: 260 patients (51.8 %) in the treatment-naïve group and 242 patients (48.2 %) in the PTF group. The mean operative time was significantly longer in the PTF group compared with the treatment-naïve group (74.9 ±â€Š30.6 vs. 67.0 ±â€Š27.1 minutes; P  = 0.002). On multivariate analysis, type of achalasia, dilated esophagus ( > 6 cm), disease duration, prior treatment, occurrence of adverse events, and type of knife used were significant predictors of operative time. Technical success (98.1 % vs. 97.1 %; P = 0.56) and clinical success (92.4 % vs. 92.5 %; P  = 0.95) were comparable in the treatment-naïve and PTF cases, respectively. Occurrence of gas-related events and mucosotomy were similar in both groups. Elevated DeMeester score was found in 17 /53 patients (32.1 %) in the PTF group and in 11 /44 patients (25.0 %) in the treatment-naïve group (P = 0.50). CONCLUSION: POEM is safe and equally effective for treatment-naïve patients and for those in whom prior treatment has failed. POEM should be considered the treatment of choice in patients in whom prior treatment has failed.

Peroral Endoscopic Myotomy in Children: First Experience With a New Triangular Knife.

OBJECTIVES: Peroral endoscopic myotomy (POEM) is a novel treatment modality for achalasia cardia. The procedure is technically challenging and time consuming. Recently, a new triangle tip knife (TTJ) has been introduced, which is equipped with water jet facility. In the present study, we analyzed the feasibility, safety, and efficacy of POEM in children with new triangle tip knife. METHODS: We retrospectively evaluated the data of children (18 years or younger) who underwent POEM using TTJ knife at our institution. All POEM procedures were performed under general anesthesia in an endoscopy suite. Technical feasibility, safety, efficacy, and procedure duration were assessed. RESULTS: Ten children (4 boys, 6 girls) with mean age of 14.2 ±â€Š2.74 (9-18) years, underwent POEM with TTJ knife. The subtypes of achalasia cardia were type I (4), type II (5), and type III (1). Two children had prior treatment with pneumatic balloon dilatation. POEM was performed via anterior route in majority of children (70%). Mean operating time was 47.6 ±â€Š19.74 (30-98) minutes with no significant difference between anterior and posterior approaches to POEM (48.57 ±â€Š24.01 vs 45.3 ±â€Š3.51; P < 0.05). Four gas-related adverse events were encountered including capnoperitoneum and retroperitoneal carbon dioxide in 2 children each. Clinical success was noticed in 9 children with significant reduction in Eckardt score at 1 month after POEM (6.7 ±â€Š1.49 vs 0.3 ±â€Š0.48; P = 0.0001). CONCLUSIONS: POEM can be efficiently performed with new triangle knife equipped with water jet technique. Integration of water jet reduces procedure duration and technical difficulty with POEM.

Management of achalasia cardia: Expert consensus statements.

Achalasia cardia (AC) is a frequently encountered motility disorder of the esophagus resulting from an irreversible degeneration of neurons. Treatment modalities are palliative in nature, and there is no curative treatment available for AC as of now. Significant advancements have been made in the management of AC over last decade. The introduction of high resolution manometry and per-oral endoscopic myotomy (POEM) has strengthened the diagnostic and therapeutic armamentarium of AC. High resolution manometry allows for the characterization of the type of achalasia, which in turn has important therapeutic implications. The endoscopic management of AC has been reinforced with the introduction of POEM that has been found to be highly effective and safe in palliating the symptoms in short-term to mid-term follow-up studies. POEM is less invasive than Heller's myotomy and provides the endoscopist with the opportunity of adjusting the length and orientation of esophageal myotomy according to the type of AC. The management of achalasia needs to be tailored for each patient, and the role of pneumatic balloon dilatation, POEM, or Heller's myotomy needs to be revisited. In this review, we discuss the important aspects of diagnosis as well as management of AC. The statements presented in the manuscript reflect the cumulative efforts of an expert consensus group.