Application of machine-learning model to optimize colonic adenoma detection in India.

AIMS: There is limited data on the prevalence and risk factors of colonic adenoma from the Indian sub-continent. We aimed at developing a machine-learning model to optimize colonic adenoma detection in a prospective cohort. METHODS: All consecutive adult patients undergoing diagnostic colonoscopy were enrolled between October 2020 and November 2022. Patients with a high risk of colonic adenoma were excluded. The predictive model was developed using the gradient-boosting machine (GBM)-learning method. The GBM model was optimized further by adjusting the learning rate and the number of trees and 10-fold cross-validation. RESULTS: Total 10,320 patients (mean age 45.18 ± 14.82 years; 69% men) were included in the study. In the overall population, 1152 (11.2%) patients had at least one adenoma. In patients with age > 50 years, hospital-based adenoma prevalence was 19.5% (808/4144). The area under the receiver operating curve (AUC) (SD) of the logistic regression model was 72.55% (4.91), while the AUCs for deep learning, decision tree, random forest and gradient-boosted tree model were 76.25% (4.22%), 65.95% (4.01%), 79.38% (4.91%) and 84.76% (2.86%), respectively. After model optimization and cross-validation, the AUC of the gradient-boosted tree model has increased to 92.2% (1.1%). CONCLUSIONS: Machine-learning models may predict colorectal adenoma more accurately than logistic regression. A machine-learning model may help optimize the use of colonoscopy to prevent colorectal cancers. TRIAL REGISTRATION: ClinicalTrials.gov (ID: NCT04512729).

Predictors of persistent pain after extracorporeal shockwave lithotripsy for painful chronic calcific pancreatitis.

BACKGROUND: Extracorporeal shockwave lithotripsy (ESWL) and/or endoscopic retrograde cholangiopancreatography (ERCP) are recommended as first-line therapy for painful uncomplicated chronic pancreatitis with obstructed main pancreatic duct (MPD) in the pancreas head/body. However, predictors of pain relief after ESWL are unknown. We evaluated independent predictors of persistent pain in patients who underwent ESWL for chronic pancreatitis. METHODS: 640 consecutive adult patients with chronic pancreatitis, who underwent successful ESWL with ERCP and pancreatic duct (PD) stent placement, were followed for 12 months. The pain was assessed at baseline and at 12 months using the Izbicki Pain Score, with a score decrease of >50% considered pain relief. Independent predictors of pain relief were derived from logistic regression analysis. RESULTS: Of 640 patients (mean age 36.71 [SD 12.19] years; 60.5% men), 436 (68.1%) had pain relief and 204 (31.9%) had persistent pain. On univariate analysis, older age, male sex, alcohol and tobacco intake, longer duration of symptoms, dilated MPD and MPD stricture were associated with persistent pain at 12 months (P<0.05). Consumption of alcohol (odds ratio [OR] 1.93, 95%CI 1.26-2.97), tobacco (OR 4.09, 95%CI 2.43-6.90), duration of symptoms (OR 1.02, 95%CI 1.01-1.04), MPD size (OR 1.22, 95%CI 1.11-1.33), and MPD stricture (OR 8.50, 95%CI 5.01-14.42) were independent predictors of persistent pain. CONCLUSIONS: Alcohol, tobacco, duration of symptoms, MPD size and stricture were independent predictors of persistent pain after successful ESWL. A multidisciplinary team approach that includes behavioral therapy and surgical options should be considered for such patients.

Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): a multicentre randomised controlled trial.

BACKGROUND: Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is a novel endoscopic method to palliate malignant gastric outlet obstruction. We aimed to assess whether the use of EUS-GE with a double balloon occluder for malignant gastric outlet obstruction could reduce the need for reintervention within 6 months compared with conventional duodenal stenting. METHODS: The was an international, multicentre, randomised, controlled trial conducted at seven sites in Hong Kong, Belgium, Brazil, India, Italy, and Spain. Consecutive patients (aged ≥18 years) with malignant gastric outlet obstruction due to unresectable primary gastroduodenal or pancreatobiliary malignancies, a gastric outlet obstruction score (GOOS) of 0 (indicating an inability in intake food or liquids orally), and an Eastern Cooperative Oncology Group performance status score of 3 or lower were included and randomly allocated (1:1) to receive either EUS-GE or duodenal stenting. The primary outcome was the 6-month reintervention rate, defined as the percentage of patients requiring additional endoscopic intervention due to stent dysfunction (ie, restenosis of the stent due to tumour ingrowth, tumour overgrowth, or food residue; stent migration; or stent fracture) within 6 months, analysed in the intention-to-treat population. Prespecified secondary outcomes were technical success (successful placement of a stent), clinical success (1-point improvement in gastric outlet obstruction score [GOOS] within 3 days), adverse events within 30 days, death within 30 days, duration of stent patency, GOOS at 1 month, and quality-of-life scores. This study is registered with ClinicalTrials.gov (NCT03823690) and is completed. FINDINGS: Between Dec 1, 2020, and Feb 28, 2022, 185 patients were screened and 97 (46 men and 51 women) were recruited and randomly allocated (48 to the EUS-GE group and 49 to the duodenal stent group). Mean age was 69·5 years (SD 12·6) in the EUS-GE group and 64·8 years (13·0) in the duodenal stent group. All randomly allocated patients completed follow-up and were analysed. Reintervention within 6 months was required in two (4%) patients in the EUS-GE group and 14 (29%) in the duodenal stent group [p=0·0020; risk ratio 0·15 [95% CI 0·04-0·61]). Stent patency was longer in the EUS-GE group (median not reached in either group; HR 0·13 [95% CI 0·08-0·22], log-rank p<0·0001). 1-month GOOS was significantly better in the EUS-GE group (mean 2·41 [SD 0·7]) than the duodenal stent group (1·91 [0·9], p=0·012). There were no statistically significant differences between the EUS-GE and duodenal stent groups in death within 30 days (ten [21%] vs six [12%] patients, respectively, p=0·286), technical success, clinical success, or quality-of-life scores at 1 month. Adverse events occurred 11 (23%) patients in the EUS-GE group and 12 (24%) in the duodenal stent group within 30 days (p=1·00); three cases of pneumonia (two in the EUS-GE group and one in the duodenal stent group) were considered to be procedure related. INTERPRETATION: In patients with malignant gastric outlet obstruction, EUS-GE can reduce the frequency of reintervention, improve stent patency, and result in better patient-reported eating habits compared with duodenal stenting, and the procedure should be used preferentially over duodenal stenting when expertise and required devices are available. FUNDING: Research Grants Council (Hong Kong Special Administrative Region, China) and Sociedad Española de Endoscopia Digestiva.

Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial.

BACKGROUND: Although the preferred management approach for patients with infected necrotising pancreatitis is endoscopic transluminal stenting followed by endoscopic necrosectomy as step-up treatment if there is no clinical improvement, the optimal timing of necrosectomy is unclear. Therefore, we aimed to compare outcomes between performing upfront necrosectomy at the index intervention versus as a step-up measure in patients with infected necrotising pancreatitis. METHODS: This single-blinded, multicentre, randomised trial (DESTIN) was done at six tertiary care hospitals (five hospitals in the USA and one hospital in India). We enrolled patients (aged ≥18 years) with confirmed or suspected infected necrotising pancreatitis with a necrosis extent of at least 33% who were amenable to endoscopic ultrasound-guided drainage. By use of computer-generated permuted block randomisation (block size four), eligible patients were randomly assigned (1:1) to receive either upfront endoscopic necrosectomy or endoscopic step-up treatment. Endoscopists were not masked to treatment allocation, but participants, research coordinators, and the statistician were. Lumen-apposing metal stents (20 mm diameter; 10 mm saddle length) were used for drainage in both groups. In the upfront group, direct necrosectomy was performed immediately after stenting in the same treatment session. In the step-up group, direct necrosectomy or additional drainage was done at a subsequent treatment session if there was no clinical improvement (resolution of any criteria of systemic inflammatory response syndrome or sepsis or one or more organ failure and at least a 25% percentage decrease in necrotic collection size) 72 h after stenting. The primary outcome was the number of reinterventions per patient to achieve treatment success from index intervention to 6 months' follow-up, which was defined as symptom relief in conjunction with disease resolution on CT. Reinterventions included any endoscopic or radiological procedures performed for necrosectomy or additional drainage after the index intervention, excluding the follow-up procedure at 4 weeks for stent removal. All endpoints and safety were analysed by intention-to-treat. This study is registered with ClinicalTrials.gov, NCT05043415 and NCT04113499, and recruitment and follow-up have been completed. FINDINGS: Between Nov 27, 2019, and Oct 26, 2022, 183 patients were assessed for eligibility and 70 patients (24 [34%] women and 46 [66%] men) were randomly assigned to receive upfront necrosectomy (n=37) or step-up treatment (n=33) and included in the intention-to-treat population. At the time of index intervention, seven (10%) of 70 patients had organ failure and 64 (91%) patients had walled-off necrosis. The median number of reinterventions was significantly lower for upfront necrosectomy (1 [IQR 0 to 1] than for the step-up approach (2 [1 to 4], difference -1 [95% CI -2 to 0]; p=0·0027). Mortality did not differ between groups (zero patients in the upfront necrosectomy group vs two [6%] in the step-up group, difference -6·1 percentage points [95% CI -16·5 to 4·5]; p=0·22), nor did overall disease-related adverse events (12 [32%] patients in the upfront necrosectomy group vs 16 [48%] patients in the step-up group, difference -16·1 percentage points [-37·4 to 7·0]; p=0·17), nor procedure-related adverse events (four [11%] patients in the upfront necrosectomy group vs eight [24%] patients in the step-up group, difference -13·4 percentage points [-30·8 to 5·0]; p=0·14). INTERPRETATION: In stabilised patients with infected necrotising pancreatitis and fully encapsulated collections, an approach incorporating upfront necrosectomy at the index intervention rather than as a step-up measure could safely reduce the number of reinterventions required to achieve treatment success. FUNDING: None.

Conventional versus oblique fiber-sparing endoscopic myotomy for achalasia cardia: a randomized controlled trial (with videos).

BACKGROUND AND AIMS: GERD is common after peroral endoscopic myotomy (POEM). Selective sparing of oblique fibers may reduce the incidence of reflux esophagitis after POEM. In this study, we compared the incidence of GERD between conventional myotomy (CM) versus oblique fiber-sparing (OFS) myotomy in patients with achalasia. METHODS: Eligible patients with type I and II achalasia who underwent POEM from January 2020 to October 2020 were randomized into 2 groups (CM and OFS myotomy). Exclusion criteria were type III achalasia, sigmoid esophagus, and history of Heller's myotomy. The primary study outcome was incidence of reflux esophagitis (at least grade B) in the 2 groups. Secondary outcomes were reflux symptoms, esophageal acid exposure, clinical success, and adverse events. RESULTS: One hundred fifteen patients were randomized into CM (n = 58) and OFS myotomy (n = 57) groups. POEM was technically successful in all patients. Overall, reflux esophagitis was found in 56 patients (48.7%). The incidence of at least grade B esophagitis was similar in both groups (CM vs OFS myotomy: 25.9% vs 31.6%, P = .541). The mean number of reflux episodes (48.2 ± 36.6 vs 48.9 ± 40.3, P = .933), increased esophageal acid exposure >6% (45.5% vs 31.7%, P = .266), and high DeMeester scores (38.6% vs 41.5%, P = .827) were similar in both groups. There was no difference in the rate of symptomatic reflux (GERD questionnaire score >7) or use of proton pump inhibitors at 1 year. CONCLUSIONS: Sparing of sling fibers has no significant impact on the incidence of significant reflux esophagitis after POEM. Novel strategies need to be explored to prevent reflux after POEM. (Clinical trial registration number: NCT04229342.).

Pre-medication with simethicone and N-acetyl cysteine for improving mucosal visibility during upper gastrointestinal endoscopy: A randomized controlled trial.

BACKGROUND AND AIM: Diagnostic performance of esophagogastroduodenoscopy (EGD) may be compromized due to adherent mucus and foam. In this study, we aimed at assessing the impact of premedication on mucosal visibility during endoscopy. METHODS: This is a double-blinded (patient and investigator), randomized trial conducted at a tertiary care centre. Patients were randomized into four groups: A (water), B (simethicone [S]), C (N-acetyl cysteine [NAC]), D (S + NAC). Premedication solutions were administered 10-30 minutes before endoscopy and mucosal visibility graded from 1 (best) to 4 (worst) (1 best, 4 worst). Total mucosal visibility scores (TMVS) from six sites ranged from 6 (best) to 24 (worst) points. The primary outcome of study was comparison of TMVS between simethicone and combination (S + NAC) premedication groups. Secondary outcomes were adverse events and impact of endoscopy timing on TMVS. RESULTS: Total 800 patients (39 years, 68.8% males) were randomized into four groups. Median TMVS were significantly lower in groups B (7 [6-8]) and D (8 [6-9]) as compared to A (11 [9-13]) and C (10 [8-12]). Proportion of cases with adequate gastric mucosal visibility (score < 7) was 26% in group A, 71% in group B, 36% in group C and 79% in group D. There was no difference in TMVS in groups A and C (p = 0.137). TMVS were significantly lower in late (> 20-30 minutes) vs. early (10-20 minutes) endoscopy sub-group (8 [7-11] vs, 9 ([7-11], p = 0.001). However, TMVS were similar between group B and group D in early endoscopy group (p = 0.451). There was no significant difference in the lesion detection rate among the different premedication drugs (p > 0.05). CONCLUSIONS: Premedication with simethicone or combination (simethicone and NAC) significantly improves mucosal visibility during EGD. If early endoscopy is indicated, simethicone provides similar mucosal visibility and may be an effective alternative to combined premedication. TRIAL REGISTRATION: NCT05951712.

Management of Disconnected Pancreatic Duct.

Disconnected pancreatic duct (DPD) is common after acute necrotizing pancreatitis (ANP). Its clinical implications vary according to the course of disease. In the early phase of ANP, parenchymal necrosis along with disruption of pancreatic duct cause acute necrotic collection that evolves into walled-off necrosis (WON). In the later phase, DPD becomes evident as confirmed by magnetic resonance cholangiopancreatography. Clinical manifestations of DPD can vary from being asymptomatic, recurrent pain, recurrent pancreatic fluid collection (PFC), obstructive pancreatitis, or external pancreatic fistula (EPF). Few patients develop new-onset diabetes. Long-term indwelling plastic stents have been proposed to prevent the recurrent PFC.

Per-oral endoscopic myotomy in cases with prior Heller's myotomy: Outcomes at a median follow-up of 5 years.

BACKGROUND AND AIM: Per-oral endoscopic myotomy (POEM) is an established treatment for achalasia cardia. However, data on the long-term efficacy of POEM in patients with failed Heller's myotomy (HM) are limited. The purpose of this study was to evaluate the long-term outcomes of POEM in patients with persistent or recurrent symptoms following HM. METHODS: Data of patients with recurrence of symptoms after HM who underwent POEM (September 2013 to December 2022) were analyzed, retrospectively. Primary outcome was clinical success [Eckardt score (ES) ≤ 3]. Secondary outcomes included improvement of manometry parameters, barium emptying at 5 min and gastroesophageal reflux (esophagitis and increased esophageal acid exposure) after POEM. RESULTS: Seventy-two cases (45.9 ± 13.4 years, 43 men) with history of HM were included in the study. The subtypes of achalasia were type 1 (40.3%), type 2 (37.5%), and unknown (19.4%). Prior treatment included HM in 48 (66.7%), HM plus pneumatic dilatation in 20 (27.8%), and HM plus pneumatic dilatation and Botox in 4 (5.5%). Technical success was achieved in all cases. Mean length of myotomy was 10.7 ± 3.3 cm, and mean procedure duration was 59.2 ± 25.9 min. There was significant improvement in ES (pre-POEM 6.5 ± 1.8 vs post-POEM 0.7 ± 0.7), lower esophageal sphincter pressure pressures (31.7 ± 12.5 vs 13.3 ± 5.7 mmHg) and barium emptying (14.2 ± 4.2 vs 2.4 ± 3.1 cm) after POEM. At a median follow-up of 63 months (IQR 40-95), clinical success (ES ≤ 3) was documented in 58 (80.6%) patients. Reflux esophagitis and increased esophageal acid exposure were recorded in 28 of 49 (57.1%) and 11 of 20 (55%) patients, respectively. CONCLUSION: POEM is a durable treatment modality in cases with relapse of symptoms after HM.

Single-Versus Multiple-Dose Antimicrobial Prophylaxis in Peroral Endoscopic Myotomy: A Randomized Controlled Study (SMAPP Trial).

Infections are uncommon after peroral endoscopic myotomy (POEM) procedure. However, prophylactic antibiotics are routinely administered for variable duration during peri-operative period. In this study, we aimed to determine the difference in the rate of infections between single (SD-A) and multiple doses (MD-A) antibiotic prophylaxis groups. The study was a prospective, randomized, non-inferiority trial conducted at a single tertiary care centre from Dec 2018 to Feb 2020. Eligible patients undergoing POEM were randomized into SD-A and MD-A groups. SD-A group received one dose of antibiotic (IIIrd gen cephalosporin) within 30-min of POEM. In the MD-A group, the same antibiotic was administered for a total of three days. Primary aim of the study was to determine the incidence of infections in the two groups. Secondary outcomes included incidence of fever (> 100 °F), inflammatory markers [erythrocyte sedimentation rate (ESR), c-reactive protein(CRP)], serum procalcitonin and adverse events related to antibiotics. (NCT03784365). 114 patients were randomized to SD-A (57) and MD-A (57) antibiotic groups. Mean post-POEM CRP (0.8 ± 0.9 vs 1.5 ± 1.6), ESR (15.8 ± 7.8 20.6 ± 11.7) and procalcitonin (0.05 ± 0.04 0.29 ± 0.58) were significantly higher after POEM (p = 0.001). Post-POEM inflammatory markers (ESR, CRP and procalcitonin) were similar in both the groups. Fever on day-0 (10.5% vs 14%) and day-1 (1.7% vs 3.5%) was detected in similar proportion of patients. Post-POEM infections were recorded in 3.5% (1.7% vs 5.3%, p = 0.618). Single dose of antibiotic is non-inferior to multiple dose antibiotic prophylaxis. Elevation of inflammatory markers and fever after POEM represents inflammation and does not predict infection after POEM.

New-onset prediabetes, diabetes after acute pancreatitis: A prospective cohort study with 12-month follow-up.

BACKGROUND: Acute pancreatitis (AP) is known to result in endocrine dysfunction (prediabetes, diabetes). The objective of this study was to determine the temporal incidence of endocrine dysfunction after onset of AP and determine the risk factors in Indian patients. METHODS: In this prospective study, enrolled patients diagnosed with AP between February 2019 and May 2019 were followed at 3, 6, and 12 months until May 2020. Patients with recurrent AP, chronic pancreatitis, and pre-existing endocrine dysfunction were excluded. Demographic and disease severity (clinical, laboratory, and radiological) data were recorded. Mann-Whitney U and Chi-square tests were used to compare groups. Temporal trend for development of endocrine dysfunction was evaluated using the Extended Mantel Haenszel Chi-square test for trend. Logistic regression was used to identify independent risk factors. RESULTS: Eighty-six patients (males 66, median [IQR] age 33.0 [26.0-44.2] years) who fulfilled enrolment criteria were finally analyzed. The most common etiology was alcohol (n=31 [36%]) followed by gallstones (n=17 [19.8%]). The proportion of patients with moderately severe acute pancreatitis and severe AP were 59.3% and 15.1%, respectively. Overall, the frequency of prediabetes and diabetes increased temporally across the follow-up period. These were 2 (2.33%) and 1 (1.16%) at 3 months, 11 (12.8%) and 5 (5.81%) at 6 months, and 20 (23.2%) and 9 (10.5%) at 1 year, respectively. On multivariable logistic regression, intervention for walled-off necrosis (WON) emerged as the single independent risk factor for endocrine dysfunction (odds ratio 9.01 [2.3-35.5]; p=0.002). CONCLUSIONS: Endocrine dysfunction is frequent after an episode of AP. Intervention for WON is an independent risk factor for endocrine dysfunction.

Predictors of Long-Term Outcomes, Recurrent Dysphagia, and Gastroesophageal Reflux After Per-oral Endoscopic Myotomy in Esophageal Motility Disorders.

BACKGROUND: There is limited data on long-term outcomes of per-oral endoscopic myotomy (POEM). In this study, we aim to evaluate the efficacy of POEM in patients who completed a minimum follow-up of 5 years. METHODS: Data of patients who underwent POEM and completed ≥ 5-year follow-up were analyzed, retrospectively. Primary outcome of study was clinical success (Eckardt ≤ 3) at ≥ 5 years after POEM. Secondary outcomes included predictors of dysphagia and symptomatic gastroesophageal reflux disease (GERD) on long-term follow-up. RESULTS: Three hundred nineteen patients (males 182, mean age 40.5 ± 14.2 years) completed a median of 73-(60-89) month follow-up. Esophageal motility disorders included idiopathic achalasia (type I 26.6%, type II 60.8%, type III 5.6%) and Jackhammer esophagus or distal esophageal spasm (2.8%). POEM was technically successful in 307 (96.2%) patients. Long-term success was 92.6% (overall), 92.1% (type I), 94.7% (type II), 87.5% (type III), and 75% (Jackhammer esophagus/distal esophageal spasm). Symptomatic GERD and reflux esophagitis were detected in 28.9% and 35.3% patients, respectively. On multivariate analysis, young age and female gender were independent risk factors for recurrent dysphagia (p = 0.037) and symptomatic GERD after POEM (p = 0.025), respectively. Lower post-POEM lower esophageal sphincter pressure was an independent predictor for reflux esophagitis (p = 0.016). CONCLUSION: POEM is an effective and durable treatment for achalasia and non-achalasia spastic motility disorders. Young patients and females may be at higher risk for recurrent dysphagia and symptomatic GERD, respectively.

POEM Is a Durable Treatment in Children and Adolescents With Achalasia Cardia.

Background and Aim: Per-oral endoscopic myotomy (POEM) is emerging as an effective treatment for pediatric achalasia. There are limited data on the long-term efficacy of POEM in children and adolescents with achalasia. In this study, we aim to evaluate the outcomes of POEM at ≥4 years follow-up. Method: The data of consecutive children who underwent POEM (September 2013-July 2021) and completed at least 4 years follow-up were analyzed retrospectively. The primary outcome was clinical success (Eckardt ≤ 3) at ≥4 years follow-up. The secondary outcomes included the prevalence of gastroesophageal reflux disease (GERD) and predictors of recurrent symptoms (Eckardt ≥2) after POEM. Results: A total of 69 children underwent POEM for achalasia during the study period. Of these, 41 (59.4%) children completed ≥4 years [mean 68.5 months (range 48-94)] follow-up, and 38 were included in the final analysis. The subtypes of achalasia included type I (28.9%), type II (60.5%), and type III (2.6%). There was a history of prior treatment in 11 children (28.9%). Clinical success was recorded in 36 (94.7%) patients who successfully underwent POEM. Recurrent symptoms (Eckardt ≥ 2) were noticed in 12 (31.6%) children at ≥4 years. On multivariate analysis, there were no identifiable factors which predicted recurrent symptoms after POEM. Symptomatic GERD and erosive esophagitis were detected in 13.8% (4/29) and 57.1% (8/14) of the children, respectively. Conclusion: POEM is a durable treatment modality for achalasia in the pediatric population irrespective of the sub-type of achalasia and history of prior treatment.

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.

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.

Outcomes of Endoscopic Submucosal Dissection in Duodenal Neuroendocrine Tumors.

BACKGROUND AND AIM: Endoscopic resection is recommended for small duodenal neuroendocrine tumors DNETs. However, there is limited data on the outcomes of endoscopic submucosal dissection (ESD) in DNETs. In this study, we aimed to evaluate the outcomes of ESD in DNETs. METHODS: Data of consecutive patients who underwent ESD for DNETs from January 2018 to December 2019 were analyzed, retrospectively. All the cases of ESD were performed with or without traction using rubber band and two endoclips. En-bloc resection, complete endoscopic resection (C-ER), complete pathological resection (C-PR), adverse events, and recurrence were evaluated. RESULTS: Twenty patients (19 males, 57.50 ± 9.32 years) underwent ESD for DNETs. DNETs measured ≤ 10 mm (7), 10-15 mm (12), and > 15 mm (1). ESD was performed with and without traction in 10 cases each. Mean operating time was 61 ± 17.38 min. En-bloc resection, C-ER, and C-PR were recorded in 90%, 95%, and 75%, respectively. Vertical margins were positive in five patients. Adverse events included perforations in 4 (20%) cases and major bleeding in one case. There was no recurrence at a mean follow-up of 17.20 ± 7.37 months. CONCLUSION: ESD is feasible and effective for the management of DNETs. However, caution is advised due to a high risk of adverse events and pathologically incomplete resection.

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.

Gastric outlet obstruction with ascites: EUS-guided gastro-enterostomy is feasible.

Background and study aims Endoscopic ultrasound-guided gastro-enterostomy(EUS-GE) is a recently described novel minimally invasive endoscopic procedure for patients having malignant gastric outlet obstruction (GOO). The safety of EUS-GE in the presence of ascites with GOO is not known. The objective of the study was to evaluate the feasibility and safety of EUS-GE in patients with GOO and ascites. Patients and methods Consecutive patients with GOO who underwent EUS-GE between January 2019 and March 2021 constituted the study population. EUS-GE was performed using either EPASS or free-hand technique. The technical success, clinical success, adverse events, and survival times were evaluated. The outcomes were compared between patients with and without ascites. Results A total of 31 patients with GOO underwent EUS-GE of whom 29 (93.5 %) had malignant and two (6.4 %) had benign etiologies. Ascites was observed in 12 out of 31 (38.7%) patients and all had underlying malignancy. Majority (27, 87 %) of the EUS-GE procedures were performed using EPASS technique, and 4 (13 %) underwent free-hand technique. Eleven of 12 patients with ascites and GOO underwent EUS GE using EPASS technique. The technical success (91.6 % vs. 89.4 %; P  = 0.841), clinical success (83.3 % vs. 89.4 %; P  = 0.619), mean procedure time (32 vs. 31.6 min; P  = 0.968) and adverse events (0 % vs. 10.5 %; P =  0.245) were not significantly different between patients with or without ascites. However, the median survival time was significantly low in patients with ascites when compared to without ascites (36 vs. 290 days; P < 001 ). Conclusions Ascites is a common occurrence in patients with malignant GOO. EUS GE is feasible in presence of ascites with EPASS technique.

Double tunnel technique reduces technical failure during POEM in cases with severe submucosal fibrosis.

Background and study aims Submucosal fibrosis (SMF) is one of the major reasons for technical failure during per-oral endoscopic myotomy (POEM). In this study, we aimed to evaluate the impact of double tunnel technique (DT-POEM) on the technical success of POEM in cases with severe SMF. Patients and methods Data from patients with achalasia in whom SMF was encountered during POEM from Jan 2013 to Jan 2020 at our center were retrospectively evaluated. The technical success and adverse events (AEs) were analyzed and compared between cases with SMF who underwent POEM via single tunnel versus DT-POEM technique. Results A total of 1,150 patients underwent POEM during the study period. There were 14 technical failures (1.2 %). SMF and severe SMF was found in 104 (9 %) and 21 (1.8 %) patients, respectively. The majority of patients (17, 80.9 %) with severe SMF had type I achalasia. Overall, technical failures occurred in 14 cases (1.2 %) and severe SMF resulted in the majority of the technical failures (10, 71.4 %). DT-POEM was utilized in 11 cases (52.4 %) with severe SMF. The median procedure time with DT-POEM was 150 minutes (85-210). There were no major AEs and DT-POEM was technically successful in all the patients. The technical success of POEM in cases with SMF improved after the adoption of the double tunnel technique (98.4 % vs 68.3 %, P  = 0.0001). Conclusions Severe SMF is the most common reason for technical failure during POEM. DT-POEM improves the technical success rates of POEM in patients with severe SMF.

Diagnostic utility of EUS-guided tissue acquisition in children: A tertiary care center experience.

BACKGROUND AND OBJECTIVES: EUS is frequently utilized for tissue acquisition in adult patients. However, the literature is limited regarding the utility of EUS-guided fine-needle aspiration or biopsy (FNA or FNB) in children. In this study, we aim to evaluate the feasibility, safety, and diagnostic utility of EUS-FNA/FNB in children with various gastrointestinal diseases. METHODS: The data of children (≤18 years) who underwent EUS-FNA/FNB from March 2014 to June 2020 were analyzed, retrospectively. The following parameters were analyzed: technical success, adverse events, and impact on the final diagnosis. RESULTS: Sixty-seven children (32 - boys, 14.8 ± 2.9 years, range 8-18 years), underwent EUS-guided tissue acquisition procedures using standard therapeutic echoendoscope during the study period. The indications included solid pancreatic lesions in 29 (43.3%), mediastinal or abdominal lymphadenopathy in 30 (44.7%), cystic pancreatic lesions in 5 (7.5%), subepithelial lesions in 2 (3%), and retroperitoneal mass in 1 (1.5%). EUS-FNA and-FNB were performed in 42 and 25 children, respectively. All the procedures could be successfully performed and there was no major procedure-related adverse event. Minor adverse events included self-limiting throat pain (10) and abdominal pain (3), self-limited bleeding at puncture site (3), and transient fever (1). EUS-FNA/FNB provided a histopathological diagnosis in 59 (88.1%) children. CONCLUSION: EUS-guided tissue acquisition using standard echoendoscope is feasible and safe in the pediatric age group. EUS-FNA/FNB establishes diagnosis in majority of the children when performed for appropriate clinical indication.