Extracorporeal Shock-Wave Lithotripsy and Endoscopy for the Treatment of Pain in Chronic Pancreatitis : A Sham-Controlled, Randomized Trial.

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.

Defining "true acid reflux" after peroral endoscopic myotomy for achalasia: a prospective cohort study.

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.).

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.).

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.

Technical performance and diagnostic yield of motorised spiral enteroscopy compared with single-balloon enteroscopy in suspected Crohn's disease: a randomised controlled, open-label study (the MOTOR-CD trial).

OBJECTIVE: Recent studies have shown that motorised spiral enteroscopy (MSE) enables deeper and total small bowel evaluation compared with single-balloon enteroscopy (SBE) in suspected Crohn's disease (CD) when analysed per procedure. However, no randomised controlled study has compared bidirectional MSE with bidirectional SBE in suspected CD. DESIGN: Patients with suspected CD requiring small bowel enteroscopy were randomly assigned to either SBE or MSE between May 2022 and September 2022 in a high volume tertiary centre. Bidirectional enteroscopy was done if intended lesion could not be reached on unidirectional study. Comparison was made with regard to technical success (ability to reach lesion), diagnostic yield, depth of maximal insertion (DMI), procedure time and total enteroscopy rates. Depth:time ratio was calculated to avoid confounding for the location of lesion. RESULTS: Among 125 suspected patients with CD (28% female, 18-65 years, median 41 years), 62 and 63 underwent MSE and SBE, respectively. The overall technical success (98.4 %: MSE, 90.5 %: SBE; p=0.11), diagnostic yield (95.2%: MSE; 87.3%: SBE, p=0.2) and procedure time were not significantly different. However, MSE appeared to have higher technical success (96.8% vs 80.7%, p=0.08) in deeper small bowel (distal jejunum/proximal ileum) with higher DMI, higher depth:time ratio and total enteroscopy rates when attempted (77.8% vs 11.1%, p=0.0007). Both the modalities were safe although minor adverse events were more common with MSE. CONCLUSION: MSE and SBE have comparable technical success and diagnostic yield for small bowel evaluation in suspected CD. MSE scores over SBE with regard to deeper small bowel evaluation with complete small bowel coverage and higher depth of insertion in a shorter time. TRIAL REGISTRATION NUMBER: NCT05363930.

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.

Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial.

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.

Endoscopic Resection of a Large Submucosal Tumor Causing Intermittent Gastric Outlet Obstruction Using a Novel Radiofrequency Enabled Device.

Gastric lipomas are rare benign tumors and account for 1-3% of all benign gastric tumors. Majority of the gastric lipomas are asymptomatic and do not demand resection. However, large gastric lipomas may present with upper gastrointestinal bleeding and more rarely gastric outlet obstruction. Traditionally, surgery has been utilized for the management of giant gastric lipomas. More recently, endoscopic techniques are increasingly utilized for the resection of gastric submucosal lesions. Here we describe a case with large gastric lipoma who presented with symptoms suggestive of gastric outlet obstruction. Gastroscopy revealed a large (6 cm) submucosal lesion with a broad peduncle located in antrum. The tumor was prolapsing into duodenum thereby, completing occluding the pylorus. In this case, we performed endoscopic submucosal dissection using a novel, bipolar radiofrequency device. The dissection was completed without any complications.

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.

Gastroesophageal reflux disease after peroral endoscopic myotomy is unpredictable, but responsive to proton pump inhibitor therapy: a large, single-center study.

BACKGROUND: Gastroesophageal reflux disease (GERD) is an important concern after peroral endoscopic myotomy (POEM). However, there are limited data on the risk factors for post-POEM GERD and its responsiveness to proton pump inhibitors (PPIs). In this study, we aimed to analyze the variables affecting the occurrence of GERD and its response to PPI therapy. METHODS: Consecutive patients with idiopathic achalasia who underwent POEM (December 2016 to January 2018) were evaluated for GERD using 24-hour pH impedance, esophagogastroduodenoscopy (EGD), and symptoms. Multivariate analysis was performed to identify the variables affecting the incidence of post-POEM GERD. RESULTS: A total of 209 patients with esophageal motility disorders, including 194 patients with non-sigmoid achalasia, underwent POEM during the study period. Comprehensive evaluation of GERD was completed on 167 patients (86.1 %): 47.3 % women with a mean (standard deviation) age of 41 (14.42) years and body mass index of 22.2 (3.89) kg/m2; the majority (70.7 %) were treatment naïve. A high DeMeester score (> 14.72), reflux esophagitis, and symptomatic GERD were identified in 47.9 %, 41.9 %, and 29.3 % of patients, respectively. On logistic regression analysis, type of achalasia, technique of POEM (anterior vs. posterior), pre- or post-POEM esophageal manometry variables, and patient characteristics were not associated with post-POEM GERD. Erosive esophagitis responded to PPI therapy in the majority of patients (81.4 %). CONCLUSION: The incidence of GERD is high after POEM. Most of the reflux esophagitis is mild and responsive to PPI therapy. There are no procedural or patient-related variables that appear to affect the incidence of post-POEM GERD.

Disconnected Pancreatic Duct in Children With Walled OFF Necrosis: Impact on Outcomes of Endoscopic Drainage.

OBJECTIVES: Disconnected pancreatic duct syndrome (DPDS) is frequently encountered in cases with walled off necrosis (WON). The impact of DPDS on the outcomes of pancreatic fluid collections (PFCs) is not well known. In this study, we aim to evaluate the incidence of DPDS and its clinical impact on the outcomes of endoscopic ultrasound (EUS)-guided drainage of PFC in children. METHODS: All children with symptomatic WON who underwent EUS-guided drainage using metal stents were included in the study. At 4 weeks, pancreatic ductal anatomy was evaluated, and metal stents removed. All the children were followed at regular intervals and evaluated for the recurrence of PFC and the development of new-onset diabetes. RESULTS: A total of 32 children (28 boys, median age 15 years) underwent EUS-guided drainage of WON. Resolution of WON was documented in all children at 4 weeks. Pancreatic ductal anatomy using magnetic resonance retrograde cholangiopancreatography and endoscopic retrograde pancreatography was available in 30 (93.7%) children. Of these, DPDS was documented in 25 (83.3%) children including proximal disconnection in 12 and distal disconnection in 13 children. Recurrent PFC and new-onset diabetes were found in 5 (20%) and 2 (8%) children with DPDS, respectively. Of the 5 recurrences of PFC, endoscopic reintervention was required in 3 children. CONCLUSIONS: Majority of the children with DPDS do not develop a symptomatic recurrence of PFC after the removal of cystogastric stents. DPDS may be a risk factor for the development of new-onset diabetes. However, future prospective studies are needed.

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.

Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis in Children With Fully Covered Self-expanding Metal Stents.

OBJECTIVES: Endoscopic ultrasound (EUS)-guided drainage with fully covered self-expanding metallic stents (FCSEMS) has been successfully used in adult patients. The utility of FCSEMS in children with walled-off necrosis (WON) is, however, unknown. The aim of present study was to evaluate the feasibility, safety, and efficacy of EUS drainage of WON using FCSEMS in children. METHODS: We retrospectively evaluated the data of children (18 years or younger) who underwent EUS drainage of WON using FCSEMS at our institution. All FCSEMS were removed between 1 and 3 months. Feasibility, safety, and efficacy were analysed. RESULTS: Twenty-one children (20 boys, mean age 14.9 ±â€Š2.34 years, range 9-18 years) underwent EUS-guided drainage of WON with FCSEMS. The median size of WON was 88 mm (55-148 mm). The median interval between onset of acute pancreatitis and EUS guided drainage was 58 days (range 30-288 days). The technical and clinical success rates were 100% and 95%, respectively. Nasocystic tube was placed in 3 children for lavage. Endoscopic necrosectomy was not required in any of the children. There were no major complications. Minor complications included bleeding (2), stent migration (1), and difficulty in removal of stent (1). After a median follow-up of 360 days (range: 30-1020 days), there was 1 recurrence of WON. CONCLUSIONS: EUS drainage of WON using specially designed FCSEMS is safe and efficacious in children. The utility of FCSEMS in children should be further explored and compared with plastic stents.

Endoscopic drainage of pancreatic fluid collections: Long-term outcomes in children.

BACKGROUND AND AIM: Endoscopic drainage of pancreatic fluid collections (PFC) is the standard of care in adult patients. The literature is limited in children. In the present study, we aim to evaluate the safety and long-term efficacy of endoscopic ultrasound (EUS)-guided drainage of PFC in children. METHODS: Data of all children (<18 years) with PFC who underwent EUS-guided drainage with plastic stents were analyzed retrospectively for technical feasibility, clinical efficacy and adverse events (AE). RESULTS: Thirty children (boys 22, girls 8) with PFC underwent EUS drainage (January 2013 to June 2016). Mean age of children was 13.07 ± 3.41 years (5-17 years). Majority of children had idiopathic pancreatitis (23), followed by trauma-related (6) and gallstone-related pancreatitis (1). Of 30 PFC, 13 (43.3%) and 17 (56.7%) were classified as pseudocyst and walled-off necrosis, respectively. Median size of PFC was 95 mm (61-175). EUS drainage was successfully completed in 29 children (technical success 96.7%). Clinical success was achieved in 28/30 (93.3%) children. AE included perforation (2), major bleed (1), minor bleed (2), stent migration (4) and readmission as a result of hematemesis (1). Imaging revealed disconnected pancreatic duct in nine, ductal leak in two and stricture in one child. Cystogastric stents were left in situ in children with disconnected duct. At median follow up of 829 days (150-1230), two recurrences of PFC were noticed. CONCLUSIONS: EUS-guided drainage using plastic stents is safe and effective in children with PFC. Cystogastric plastic stents can be left safely long term. However, more studies with larger sample sizes are required.

Peroral endoscopic myotomy for achalasia cardia: Treatment analysis and follow up of over 200 consecutive patients at a single center.

BACKGROUND AND AIM: Peroral endoscopic myotomy (POEM) is a recently introduced technique for the treatment of achalasia cardia (AC). Data regarding safety and efficacy are still emerging. We report our experience of POEM emphasizing its safety, efficacy and follow-up data. METHODS: Patients with AC (220; mean age 39 years, range 9-74 years) underwent POEM from January 2013 to August 2014 for AC. Retrospective analysis of prospectively collected data was done. POEM was carried out by the standard technique of mucosal incision, submucosal tunneling, and myotomy of the esophageal and gastric muscle bundles followed by closure of the mucosal incision by hemoclips. Eckardt score, high-resolution manometry (HRM) and timed barium esophagogram (TBE) were used to evaluate the results. Post-procedure patients were followed up. RESULTS: Technical success rate of POEM was 96%. At 1 year, clinical success rate was 92%. Mean Eckardt score was 7.2 ± 1.55 prior to POEM and 1.18 ± 0.74 after POEM (P = 0.001). There was significant improvement of esophageal emptying on TBE (38.4 ± 14.0 % vs 71.5 ± 16.1 % (P = 0.001). Pre-procedure and post-procedure mean lower esophageal sphincter pressure was 37.5 ± 14.5 mmHg and 15.2 ± 6.3 mmHg, respectively. (P = 0.001) Erosive esophagitis was seen in 16% of patients who underwent POEM. There were no major adverse events. CONCLUSIONS: Study demonstrates excellent safety profile of POEM with significant relief of symptoms, reduced pressure at HRM and improved emptying at TBE. Further prospective studies are required to compare with other treatment modalities.