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INTRODUCTION: Acute cholangitis is a critical medical emergency. The association between the timing of ERCP and clinical outcomes of acute cholangitis is still debated. The current study aims to evaluate whether ERCP within 48 h (urgent) is associated with improved long term clinical outcomes. METHODS: This study is a single-center retrospective analysis of a prospectively maintained database. All patients admitted with acute cholangitis as per Tokyo guidelines at AIG Hospitals, Hyderabad between January 2022 to December 2022 were included. We evaluated the association between urgent ERCP and length of hospital stay, need for reintervention and readmissions, and mortality. RESULTS: A total of consecutive 301 patients underwent ERCP for acute cholangitis; of which 217 patients (31.3 % females; mean age 54.02 ± 14.9 years) underwent urgent ERCP. The remaining 84 (32.1 % females; mean age 56.56 ± 13.9 years) underwent routine ERCP. Fifty-eight (26.7 %) and 22 (26.2 %) patients with Grade III underwent urgent and routine ERCP respectively. The median (IQR) hospital stay for urgent ERCP was 8.00 (6.00 - 11.00) days and for routine ERCP was 11.00(8.00 - 15.00; p value 0.0001), with similar hospital stay post ERCP (p 0.26). There was no significant difference in mortality upto one year between patients who underwent urgent (22.1 %;48/217) or routine ERCP (31.0 %;26/84, p 0.135). The cox proportional hazard model showed that mortality is independently associated with older age (HR 1.034;95 %CI: 1.013 - 1.054; p 0.001) and malignancy (HR 8.64;95 %CI:4.728 - 15.790; p 0.0001). There was no significant difference between two groups in terms of need for reinterventions and readmissions. CONCLUSIONS: Urgent ERCP for acute cholangitis is associated comparable overall mortality, need for reinterventions, and readmissions with decreased total length of hospital stay. There is an unmet need to confirm these findings by randomized controlled studies.
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INTRODUCTION: The role of endo-biliary radio-frequency ablation (EB-RFA) in treating malignant biliary strictures remains a subject of controversy. This study aims to assess the efficacy and safety of EB-RFA in conjunction with self-expandable metal stents (SEMS) compared to SEMS alone. METHODS: This single-center prospective pragmatic comparative study, conducted between June 2021 and November 2022, involved 23 patients undergoing EB-RFA plus SEMS and 48 patients undergoing SEMS for unresectable malignant hilar obstruction. The study evaluated overall survival, stent patency and adverse events. RESULTS: Seventy-one patients (mean age [SD], 57.8 [11.2] years; 73.2% men) were enrolled. The clinical success rates did not significantly differ between the two groups (78.3% in EB-RFA and 66.6% in SEMS; p 0.316). The median (95% CI) overall survival was 155 (79.87-230.13) days in the EB-RFA group, contrasting with 86.0 (78.06-123.94) days in the SEMS group (p 0.020). The presence of carcinoma gallbladder (p 0.035; HR 0.55; 95% CI 0.32-0.96) and EB-RFA (p 0.047; HR 1.88; 95% CI 1.01-3.49) independently predicted overall survival. Median (95% CI) stent patency was 143.0 (95% CI, 61.61-224.39) days in the EB-RFA group compared to 78.0 (95% CI, 32.74-123.26) days in the SEMS group (p 0.019). The presence of carcinoma gallbladder (p 0.046, HR 0.60; 95% CI, 0.36-0.99), EB-RFA (p 0.023; HR 1.92; 95% CI, 1.10-3.36) and chemotherapy (p 0.017, HR 1.91; 95% CI, 1.12-3.26) independently predicted longer stent patency. There was no difference in procedure-related adverse events in both groups. CONCLUSION: EB-RFA with SEMS placement proves to be a safe and effective technique for palliative biliary decompression in patients with malignant biliary strictures, demonstrating superior overall survival and stent patency compared to SEMS alone. Further confirmation through multi-center trials is warranted. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (ID: NCT05320328).
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BACKGROUND: Endoscopic ultrasound (EUS)-guided drainage of walled-off necrosis (WON) using either plastic or metal stents is the mainstay of WON management. Our single-center randomized controlled trial aimed to evaluate the efficacy of biflanged metal stents (BFMSs) and plastic stents for WON drainage. METHODS: Patients with symptomatic WON amenable to EUS-guided drainage were randomized to receive either BFMSs or plastic stents. The primary outcome was reintervention-free clinical success at 4 weeks. Secondary outcomes were: overall clinical success (complete resolution of symptoms and significant reduction in size of WON [<50% of original size and <5 cm in largest diameter at 4-week follow-up]); number of reinterventions; adverse events (AEs); hospital stay for first admission; and medium-term outcomes at 6 months (recurrence, disconnected pancreatic duct, chronic pancreatitis, and new-onset diabetes mellitus). RESULTS: 92 patients were randomized: 46 in each arm. The reintervention-free clinical success rate was significantly higher in the BFMS group on intention-to-treat analysis (67.4% vs. 43.5%; P = 0.02). Overall clinical success at 1 month was similar in both groups. There were significantly fewer reinterventions (median 0 [IQR 0-1] vs. 1 [0-2]; P = 0.03) and shorter hospital stays in the BFMS group (7.0 [SD 3.4] vs. 9.1 [5.5] days; P = 0.04). There were no differences in procedure-related AEs, mortality, or medium-term outcomes. CONCLUSIONS: BFMSs provide better reintervention-free clinical success at 4 weeks, with shorter hospital stay and without increased risks of AEs, compared with plastic stents for EUS-guided drainage of WON. Medium-term outcomes are however similar for both stent types.
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BACKGROUND: No randomized controlled trials have substantiated endoscopic decompression of the pancreatic duct in patients with painful chronic pancreatitis. OBJECTIVE: To investigate the pain-relieving effect of pancreatic duct decompression in patients with chronic pancreatitis and intraductal stones. DESIGN: 24-week, parallel-group, randomized controlled trial (ClinicalTrials.gov: NCT03966781). SETTING: Asian Institute of Gastroenterology in India from February 2021 to July 2022. PARTICIPANTS: 106 patients with chronic pancreatitis. INTERVENTION: Combined extracorporeal shock-wave lithotripsy (ESWL) and endoscopic retrograde pancreatography (ERP) compared with sham procedures. MEASUREMENTS: The primary end point was pain relief on a 0- to 10-point visual analog scale (VAS) at 12 weeks. Secondary outcomes were assessed after 12 and 24 weeks and included 30% pain relief, opioid use, pain-free days, questionaries, and complications to interventions. RESULTS: 52 patients in the ESWL/ERP group and 54 in the sham group were included. At 12 weeks, the ESWL/ERP group showed better pain relief compared with the sham group (mean difference in change, -0.7 [95% CI, -1.3 to 0] on the VAS; P = 0.039). The difference between groups was not sustained at the 24-week follow-up, and no differences were seen for 30% pain relief at 12- or 24-week follow-up. The number of pain-free days was increased (median difference, 16.2 days [CI, 3.9 to 28.5 days]), and the number of days using opioids was reduced (median difference, -5.4 days [CI, -9.9 to -0.9 days]) in the ESWL/ERP group compared with the sham group at 12-week follow-up. Safety outcomes were similar between groups. LIMITATION: Single-center study and limited duration of follow-up. CONCLUSION: In patients with chronic pancreatitis and intraductal stones, ESWL with ERP provided modest short-term pain relief. PRIMARY FUNDING SOURCE: Asian Institute of Gastroenterology and Aalborg University Hospital.
Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Lithotripsy , Pancreatic Ducts , Pancreatitis, Chronic , Humans , Pancreatitis, Chronic/complications , Pancreatitis, Chronic/therapy , Male , Female , Lithotripsy/adverse effects , Lithotripsy/methods , Middle Aged , Adult , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Pancreatic Ducts/diagnostic imaging , Pain Measurement , Abdominal Pain/etiology , Abdominal Pain/therapy , Pain Management/methods , Treatment OutcomeABSTRACT
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).
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Video 1Migrated lumen-apposing stent trapped within a pancreatic fluid collection: forward-view EUS for the rescue!
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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.
Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Lithotripsy , Pancreatitis, Chronic , Adult , Female , Humans , Male , Middle Aged , Abdominal Pain/etiology , Alcohol Drinking/adverse effects , Calcinosis/therapy , Calcinosis/etiology , Calculi/therapy , Calculi/complications , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Lithotripsy/adverse effects , Lithotripsy/methods , Pain Measurement , Pancreatic Ducts , Pancreatitis, Chronic/complications , Pancreatitis, Chronic/therapy , Risk Factors , StentsABSTRACT
BACKGROUND AND AIMS: The symptoms of reflux in achalasia patients undergoing peroral endoscopic myotomy (POEM) are believed to result from gastroesophageal reflux, and the current treatment primarily focuses on acid suppression. Nevertheless, other factors such as nonreflux acidification caused by fermentation or stasis might play a role. This study aimed to identify patients with "true acid reflux" who actually require acid suppression and fundoplication. METHODS: In this prospective large cohort study, the primary objective was to assess the incidence and risk factors for true acid reflux in achalasia patients undergoing POEM. Acid reflux with normal and delayed clearance defined true acid reflux, whereas other patterns were labeled as nonreflux acidification patterns on manual analysis of pH tracings. These findings were corroborated with a symptom questionnaire, esophagogastroscopy, esophageal manometry, and timed barium esophagogram at 3 months after the POEM procedure. RESULTS: Fifty-four achalasia patients aged 18 to 80 years (mean age, 41.1 ± 12.8 years; 59.3% men; 90.7% with type II achalasia) underwent POEM, which resulted in a significant mean Eckardt score improvement (6.7 to 1.6, P < .05). True acid reflux was noted in 29.6% of patients as compared with 64.8% on automated analysis. Acid fermentation was the predominant acidification pattern seen in 42.7% of patients. On multivariable logistic regression analysis, increasing age (odds ratio, 1.12; 95% confidence interval, 1.02-1.27; P = .04) and preprocedural integrated relaxation pressure (IRP; odds ratio, 1.13; 95% confidence interval, 1.04-1.30; P = .02) were significantly associated with true acid reflux in patients after undergoing POEM. CONCLUSIONS: A manual review of pH tracings helps to identify true acid reflux in patients with achalasia after undergoing POEM. Preprocedural IRP can be a predictive factor in determining patients at risk for this outcome. (Clinical trial registration number: NCT04951739.).
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Esophageal Achalasia , Esophagitis, Peptic , Gastroesophageal Reflux , Myotomy , Natural Orifice Endoscopic Surgery , Adult , Female , Humans , Male , Middle Aged , Cohort Studies , Esophageal Achalasia/complications , Esophageal Sphincter, Lower/surgery , Esophagitis, Peptic/etiology , Esophagoscopy/methods , Gastroesophageal Reflux/epidemiology , Gastroesophageal Reflux/etiology , Manometry/methods , Myotomy/methods , Natural Orifice Endoscopic Surgery/adverse effects , Prospective Studies , Treatment Outcome , Adolescent , Young Adult , Aged , Aged, 80 and overABSTRACT
Gastric and duodenal perforation from ingested organic and inorganic foreign bodies, such as sewing needles, toothpick, metallic wires, fish and chicken bone, are uncommon incidents as most foreign bodies pass in the faeces. The perforated foreign body can at times migrate and either penetrate causing traumatic injury or incite inflammation with formation of abscesses or pseudo-tumours in the adjacent organs such as the liver and pancreas. We report one such case of pancreatitis in a child resulting from a metallic wire perforating the posterior gastric wall and penetrating the pancreas. The findings were detected on CT and the foreign body was extracted endoscopically. We also present review of literature on similar case reports.
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Obesity in paediatrics has become one of the most serious public health concerns worldwide. Paediatric obesity leads to increased adult obesity and is associated with several comorbidities, both physical and psychological. Within gastroenterology, non-alcoholic fatty liver disease (NAFLD) is now the most common cause of paediatric liver disease and the most common cause of liver transplantation in young adults. Treatment for NAFLD largely focuses on treatment of obesity with weight loss strategies. Unfortunately, the traditional method of weight loss using multicomponent lifestyle modification (dietary changes, increased exercise and behavioural modification) has often led to disappointing results. In adult patients with obesity, treatment strategies have evolved to include bariatric surgery and, more recently, bariatric endoscopy. In paediatrics, the obesity and NAFLD epidemics will likely require this variety of treatment to address children in a personalized manner. Here, we present a review of paediatric obesity, paediatric NAFLD and the various treatment strategies to date. We focus on non-pharmacologic and emerging therapies, including bariatric surgery and bariatric endoscopy-based treatments. With such a large population of children and adolescents with obesity, further development of these treatments, including paediatric-focused clinical trials, is essential for these emerging modalities.
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Bariatric Surgery , Non-alcoholic Fatty Liver Disease , Pediatric Obesity , Adolescent , Young Adult , Humans , Child , Pediatric Obesity/epidemiology , Pediatric Obesity/therapy , Non-alcoholic Fatty Liver Disease/epidemiology , Non-alcoholic Fatty Liver Disease/therapy , Behavior TherapyABSTRACT
Background and study aims Capsule endoscopy (CE) has transformed examination of the small bowel (SB), once considered a dark continent. The present study aimed to describe the indications, diagnostic yield, practical issues and complications of CE in one of the largest tertiary center in India. Patients and methods This retrospective analysis from a prospectively maintained database, conducted from January 2013 to June 2021 included 1155 CEs performed during this period. Patient medical records were reviewed for indications, results, and complications of CE. Results A total of 1154 patients (809 males and 345 females), mean age 53 years (range 6-87 years), one capsule got stuck in the esophagus, were included in the study. Active SB bleeding had no effect on SB transit time (324.7±161 minutes, n = 137 patients with active bleed vs 310.6±166.9 minutes, n = 1017 patients without active bleed; P = 0.35). The indication and diagnostic yield (DY) of CE were potential overt SB bleed (68.6% & 43.9%), potential occult SB bleed (8.2% and 40%), chronic diarrhea (7.9% and 28.4%), abdominal pain (6.5% and 21.3%), anemia (5.9% and 57.9%), and suspected/known case of Crohn's disease (2.3% & 56.5%) respectively. The DY for patients with age ≥60 years was similar to those with age < 60 years (61.9% vs. 51.8% respectively; P = 0.4). 21 patients (1.8%) had capsule retention of which six (0.5%) had to be referred for surgery. Conclusions CE is a safe and effective investigation with ever increasing range of indications. Potential SB bleed remains the most common indication for CE with high detection rate.
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Background and study aims Percutaneous liver biopsy is traditionally done on the right lobe of the liver. Endoscopic ultrasound-guided liver biopsy (EUS-LB) can be performed on either the left or right lobe or as a combined bi-lobar biopsy. Earlier studies did not compare the benefit of bi-lobar biopsies to single-lobe biopsy for reaching a tissue diagnosis. The current study compared the degree of agreement of pathological diagnosis between the left lobe of the liver compared to right-lobe and with bi-lobar biopsy. Patients and methods Fifty patients fulfilling the inclusion criteria were enrolled in the study. EUS-LB with a 22G core needle was performed separately on both the liver lobes. Three pathologists, who were blinded to the site of biopsy independently reviewed the liver biopsies. Sample adequacy, safety, and concordance of pathological diagnosis between left- and right-lobe biopsy of the liver were analyzed. Results The pathological diagnosis was made in 96â% of patients. Specimen lengths from the left lobe and the right lobe were 2.31â±â0.57âcm and 2.28â±â0.69âcm, respectively ( P â=â0.476). The respective number of portal tracts were 11.84â±â6.71 versus 9.58â±â7.14; P â=â0.106.âDiagnosis between the two lobes showed substantial (κâ=â0.830) concordance. Left-lobe (κ value 0.878) and right-lobe (κâ=â0.903) biopsies showed no difference when compared with bi-lobar biopsies. Adverse events were observed in two patients, both of whom had biopsies of the right lobe. Conclusions EUS-guided left-lobe liver biopsy is safer than right-lobe biopsy with similar diagnostic yield.
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Artificial Intelligence (AI) is a mathematical process of computer mediating designing of algorithms to support human intelligence. AI in hepatology has shown tremendous promise to plan appropriate management and hence improve treatment outcomes. The field of AI is in a very early phase with limited clinical use. AI tools such as machine learning, deep learning, and 'big data' are in a continuous phase of evolution, presently being applied for clinical and basic research. In this review, we have summarized various AI applications in hepatology, the pitfalls and AI's future implications. Different AI models and algorithms are under study using clinical, laboratory, endoscopic and imaging parameters to diagnose and manage liver diseases and mass lesions. AI has helped to reduce human errors and improve treatment protocols. Further research and validation are required for future use of AI in hepatology.
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BACKGROUND AND AIMS: Lack of clinical validation and inter-observer variability are two limitations of endoscopic assessment and scoring of disease severity in patients with ulcerative colitis [UC]. We developed a deep learning [DL] model to improve, accelerate and automate UC detection, and predict the Mayo Endoscopic Subscore [MES] and the Ulcerative Colitis Endoscopic Index of Severity [UCEIS]. METHODS: A total of 134 prospective videos [1550 030 frames] were collected and those with poor quality were excluded. The frames were labelled by experts based on MES and UCEIS scores. The scored frames were used to create a preprocessing pipeline and train multiple convolutional neural networks [CNNs] with proprietary algorithms in order to filter, detect and assess all frames. These frames served as the input for the DL model, with the output being continuous scores for MES and UCEIS [and its components]. A graphical user interface was developed to support both labelling video sections and displaying the predicted disease severity assessment by the artificial intelligence from endoscopic recordings. RESULTS: Mean absolute error [MAE] and mean bias were used to evaluate the distance of the continuous model's predictions from ground truth, and its possible tendency to over/under-predict were excellent for MES and UCEIS. The quadratic weighted kappa used to compare the inter-rater agreement between experts' labels and the model's predictions showed strong agreement [0.87, 0.88 at frame-level, 0.88, 0.90 at section-level and 0.90, 0.78 at video-level, for MES and UCEIS, respectively]. CONCLUSIONS: We present the first fully automated tool that improves the accuracy of the MES and UCEIS, reduces the time between video collection and review, and improves subsequent quality assurance and scoring.
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Colitis, Ulcerative , Deep Learning , Humans , Colitis, Ulcerative/diagnostic imaging , Colonoscopy , Prospective Studies , Artificial Intelligence , Severity of Illness IndexABSTRACT
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.
Subject(s)
Diabetes Mellitus , Pancreatitis , Prediabetic State , Male , Humans , Adult , Pancreatitis/epidemiology , Pancreatitis/etiology , Pancreatitis/diagnosis , Prediabetic State/etiology , Prediabetic State/complications , Prospective Studies , Acute Disease , Follow-Up Studies , Diabetes Mellitus/epidemiology , Risk FactorsABSTRACT
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.
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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 (nâ=â52) and no-stenting (nâ=â52) groups. Plastic stent deployment was successful in 88.5â%. Migration occurred in 19.2â% at median follow-up of 8 months (IQR 2.5-12). Recurrent PFCs occurred in six patients at 3 months (stent nâ=â3, no stent nâ=â3). 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.
Subject(s)
Pancreatic Diseases , Adult , Drainage/methods , Endosonography/methods , Humans , Male , Metals , Necrosis/etiology , Pancreatic Diseases/complications , Pancreatic Ducts/surgery , Retrospective Studies , Stents/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: The majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD. DESIGN: Patients with proton pump inhibitor (PPI)-dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months. RESULTS: Seventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29-42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9-100.0) versus 8.0 (2.2-21.6); p<0.001) and 12 (92.3 (84.4-100.0) versus 9.1 (4.8-36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group. CONCLUSION: EFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate. TRIAL REGISTRATION NUMBER: NCT03322553.
Subject(s)
Esophagitis, Peptic , Gastroesophageal Reflux , Adult , Endoscopy, Gastrointestinal , Female , Gastroesophageal Reflux/complications , Gastroesophageal Reflux/surgery , Humans , Male , Proton Pump Inhibitors/therapeutic use , Quality of Life , Treatment OutcomeABSTRACT
Endoscopic therapies in proton pump inhibitors (PPI) dependent/refractory gastroesophageal reflux disease (GERD) are increasingly indicated in patients who are not suitable or willing for chronic medical therapy and surgical fundoplication. Currently available endoluminal anti-reflux procedures include radiofrequency therapy (Stretta), suturing/plication and mucosal ablation/resection techniques at the gastroesophageal junction. Meticulous work up and patient selection results in a favorable outcome with these endoscopic therapies, especially the quality of life and partially the PPI independence. Stretta can be considered in patients with PPI refractory GERD and might have a role in patients with reflux hypersensitivity and functional heartburn. Endoscopic fundoplication using the Esophyx device and the GERD-X device have strong evidence (multiple randomized controlled trials) in patients with small hiatus hernia and high volume reflux episodes. Mucosal resection/ablation techniques like anti-reflux mucosectomy and anti-reflux mucosal ablation have shown promising results but need long term follow-up studies to prove their efficacy. The subset of PPI dependent GERD population will benefit from endoscopic therapies and the future of endoscopic management of GERD looks promising.