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.).

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.

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.

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.

Impact of prior treatment on long-term outcome of peroral endoscopic myotomy in pediatric achalasia.

BACKGROUND AND AIM: Peroral endoscopic myotomy (POEM) is emerging as an effective treatment for achalasia in children. Long-term outcomes of POEM and impact of prior treatment are not known in pediatric population. In this study, we aim to evaluate the long-term efficacy of POEM in children with achalasia. METHODS: Children (≤18 years) with achalasia who underwent POEM and completed at least 36 months of follow-up were included in the study. Long-term clinical success (Eckardt ≤3) was evaluated and compared between treatment naïve versus prior treated cases. RESULTS: A total of 53 children underwent POEM at our center during the study period. Of these, 17 children completed at least 3 years of follow-up and were included in the study. Eight children had prior treatment including pneumatic dilatation (6), Heller's myotomy (1) and both Heller's myotomy and pneumatic dilatation (1). POEM was successfully completed in all the children. Median procedure duration was 95.76 ±â€¯47.98 min (38-240 min.). Long-term clinical success was found in 88.2% children. The mean follow-up was 55.06 ±â€¯10.65 months (range 36-67 months). There was no significant difference in the success rate between treatment naïve and prior treatment failure cases. CONCLUSION: POEM is a safe, effective and durable treatment for achalasia in children. Prior treatment does not affect the outcomes of POEM in children. TYPE OF STUDY: Retrospective comparative study. LEVEL OF EVIDENCE: III.

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.

Outcomes of submucosal tunneling endoscopic resection in upper gastrointestinal sub-epithelial tumors.

BACKGROUND: Submucosal tunneling techniques have expanded the horizon of therapeutic endoscopy. One such procedure, submucosal tunneling endoscopic resection (STER), enables the endoscopic removal of gastrointestinal (GI) sub-epithelial tumors. In this study, we aimed to evaluate the safety and efficacy of STER in patients with sub-epithelial lesions localized to the upper GI tract. METHODS: Consecutive subjects with a sub-epithelial lesion of ≥ 1 cm size in the upper GI tract were enrolled in the study. STER was performed using the standard technique in an endoscopy suite. A modified technique (double-opening STER) was used in cases with difficult en bloc resection of the tumor. Outcome measures included technical success, en bloc resection rates, adverse events, and recurrence. RESULTS: A total of 104 patients with sub-epithelial tumors were evaluated for STER. Of them, 44 subjects (mean age 44.68 ± 12.82, 52.3% males) underwent standard STER. Majority (31, 70.4%) of the lesions were located in the esophagus and cardia. Technical success and en bloc removal of the tumor were achieved in 97.7% and 88.4% of cases, respectively. There was no major adverse event. Minor adverse events were recorded in 7 (15.9%) cases. Majority (31, 70.4%) of the tumors originated from muscularis propria, followed by submucosa (8, 18.2%) and muscularis mucosa (5, 11.4%). The most common histological diagnosis was leiomyoma (59.1%) followed by GI stromal tumors (20.4%). At a mean follow up of 12.36 ± 7.63 months, there was no incidence of tumor recurrence in en bloc as well as piecemeal resection groups. CONCLUSION: STER is a safe and efficacious procedure for sub-epithelial tumors in the upper GI tract. Novel strategies need to be developed to ensure en bloc removal of large lesions.

Outcomes of anterior myotomy versus posterior myotomy during POEM: a randomized pilot study.

BACKGROUND AND STUDY AIMS: Peroral endoscopic myotomy (POEM) can be performed via an anterior or posterior approach, depending on the operator's preference. Data are lacking on comparative outcomes of both approaches. PATIENTS AND METHODS: This is a pilot randomized study comparing endoscopic anterior and posterior myotomy during POEM in patients with Achalasia cardia (AC). Patients were randomized into 2 groups (n = 30 in each group); anterior myotomy group (AG) and posterior myotomy group (PG) and were followed at 1, 3 and 6 months after POEM. RESULTS: Technical success was achieved in 100 % of cases in both groups and total operative time was comparable (AG - 65 ±â€Š17.65 minutes versus PG - 61.2 ±â€Š16.67; P  = 0.38); Mucosotomies were more frequent in AG (20 % vs 3.3 %; P  = 0.02). Difference in other perioperative adverse events (AE) including insufflation-related AE and bleeding in both groups were statistically insignificant. At 1-month follow-up Eckardt score AG 0.57 ±â€Š0.56 vs PG 0.53 ±â€Š0.71; ( P  = 0.81), mean LES pressure AG 11.93 ±â€Š6.36 vs PG 11.77 ±â€Š6.61; ( P  = 0.59) and esophageal emptying on timed barium swallow at 5 minutes AG 1.32 ±â€Š1.08 cm vs PG 1.29 ±â€Š0.79 cm; ( P  = 0.09) were comparable in both groups. At 3 months, Eckardt score (0.52 ±â€Š0.59 vs 0.63 ±â€Š0.62; P  = 0.51) was similar in both groups. Incidence of esophagitis on EGD was comparable in both groups (24 % vs 33.3 %; P  = 0.45), however, pH metry at 3 months showed significantly more esophageal acid exposure in posterior group (2.98 % ±â€Š4.24 vs 13.99 % ±â€Š14.48; P  < 0.01). At 6 months clinical efficacy and LES pressures were comparable in both groups. CONCLUSION: Anterior and posterior approaches to POEM seem to have equal efficacy. However, the occurrence of mucosotomies was higher in the anterior myotomy group and acid exposure was higher with the posterior myotomy approach during POEM.

Anesthesia in per-oral endoscopic myotomy: A large tertiary care centre experience.

BACKGROUND AND OBJECTIVES: Per-oral endoscopic myotomy (POEM) is safe and efficacious for the management of achalasia cardia (AC). POEM is usually performed under general anesthesia in an endoscopy suite or operating theatre. The current study was conducted with the aim to analyse anesthetic management of patients with AC who underwent POEM at our institution. METHODS: We retrospectively analysed the data of patients with AC who underwent POEM at our institution from January 2013 to September 2016. All cases were performed in an endoscopy suite under supervision of an anesthesia management team. Pre-procedure endoscopic evacuation of esophagogastric contents was done in all cases. Management strategies used for gas-related adverse events and outcomes were assessed. RESULTS: Four hundred and eighty patients (median age 40 years, range 4-77 years) underwent POEM during the study period. The sub-types of AC were type I (163), type II (297), and type III (20). POEM was successfully completed in 97.5% patients. Gas-related events were noted in 30.6% cases including-capno-thorax in 1%, capno-peritoneum in 12.3%, retroperitoneal air in 16.5%, capno-mediastinum in 0.2%, and capno-pericardium in 0.4% patients. Significant rise in end tidal CO2 (> 45) and peak airway pressure were observed in 8.1% and 5.4% cases, respectively. Drainage was required in 12.3% patients. There was no occurrence of aspiration during or after POEM. CONCLUSIONS: POEM could be safely performed in an endoscopy suite under supervision of an expert anesthesia management team. Gas-related adverse events were common during POEM and could be managed with a standardized approach.

Per Oral Endoscopic Myotomy in Children with Achalasia Cardia.

BACKGROUND/AIMS: Achalasia cardia (AC) is a motility disorder, characterized by impaired lower esophageal sphincter relaxation and absence of esophageal peristalsis. AC is rare in children with unclear optimum management strategies. Per oral endoscopic myotomy (POEM) is a novel technique for management of achalasia with encouraging results in adult patients. The efficacy and safety of POEM is not known for pediatric AC. The aim of our study was to evaluate the safety and efficacy of POEM in children with achalasia cardia. METHODS: The data of all children (< 18 years) who underwent POEM at our center was retrospectively analysed. Symptoms were analysed using a validated score (Eckardt score) at regular predefined intervals. Objective parameters including high-resolution manometry, timed barium swallow and esophagogastroduodenoscopy were assessed before the procedure and at 1-year follow-up. Clinical success was defined as an Eckardt score ≤ 3. RESULTS: A total of 15 children underwent POEM during the specified period. Ten out of 15 (10/15) completed 1-year follow-up. Median operative time was 100 (38-240) minutes. Mean pre and post procedure LES pressure were 36.64 ± 11.08 mmHg and 15.65 ± 5.73 mmHg, respectively (P = 0.001). Mean Eckardt score before and after the POEM was 7.32 ± 1.42 and 1.74 ± 0.67, respectively (P = 0.001). Mean percentage improvement in barium emptying at 5 minutes was 63.70 ± 4.46%. All children had complete resolution of symptoms at 1 year. Median weight gain of children at 1 year was 0.65 kg (range, 0.0-4.6). CONCLUSIONS: POEM is safe and effective for children and adolescents with achalasia. Future trials with larger sample size are warranted to establish its efficacy in pediatric AC.

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.

Epidural anesthesia is effective for extracorporeal shock wave lithotripsy of pancreatic and biliary calculi.

AIM: To evaluate the efficacy of thoracic epidural analgesia for extracorporeal shock wave lithotripsy (ESWL). METHODS: ESWL is an effective, non-invasive technique for the treatment of difficult pancreatic and large bile duct calculi. The procedure is often painful and requires large doses of analgesics. Many different anesthetic techniques have been used. Patients with either large bile duct calculi or pancreatic duct calculi which could not be extracted by routine endoscopic methods were selected. Thoracic epidural anesthesia (TEA) was routinely used in all the subjects unless contraindicated. Bupivacaine 0.25% with or without clonidine was used to block the segments D6 to D12. The dose was calculated depending on the age, height and weight of the patient. It was usually 1-2 mL per segment blocked. RESULTS: Ninety eight percent of the 1509 patients underwent ESWL under TEA. The subjects selected were within American Society of Anesthesiologists grade I to III. ESWL using EA permitted successful elimination of bile duct or pancreatic calculi with minimal morbidity. The procedure time was shorter in patients with TEA than in those who underwent ESWL under total intravenous anesthesia. CONCLUSION: Almost all patients undergoing ESWL with EA had effective blocks with a single catheter insertion and local anesthetic injection.