An international multicenter study evaluating the clinical efficacy and safety of per-oral endoscopic myotomy in octogenarians.

BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) for achalasia is particularly appealing in the elderly because it is minimally invasive. However, data in patients aged ≥80 years are scarce. The aim of this study was to assess the clinical outcome of POEM in octogenarians. METHODS: This was a multicenter retrospective study at 8 centers. Consecutive octogenarians with achalasia who underwent POEM between 2010 and 2016 were included. Rates of technical success (completion of myotomy), clinical response (Eckardt score ≤3), and adverse events (severity graded as per American Society for Gastrointestinal Endoscopy lexicon) were assessed. RESULTS: A total of 76 patients (47.4% female, mean age 84 years) underwent POEM for treatment of achalasia: type I, 17.1%; type II, 35.5%; type III, 17.1%; and unspecified, 30.3%. Overall, 41.1% were treatment naïve, whereas others had previous botulinum toxin injection and/or pneumatic dilation. The mean (± standard deviation [SD]) age-adjusted Charlson comorbidity index score was 6.2 ± 2.4, with the majority of patients having American Society of Anesthesiologists Physical Status Classification System (ASA) scores of II/III. Technical success was 93.4%, with a median follow-up of 256 days. Fourteen adverse events occurred in 11 patients (14.5%). There were 3 inadvertent mucosotomies, 6 cases of symptomatic capnoperitoneum and/or capnomediastinum, 2 esophageal leaks, 1 cardiac arrhythmia, and 2 other). The severities of these adverse events were mild (78.6%), moderate (14.3%), and severe (7.1%). Clinical success was achieved in 90.8% of patients, with a mean (± SD) Eckardt score reduction from 7.0 ± 2.3 to 0.8 ± 0.1 (P < .001), a median follow-up of 256 days, and interquartile range of 66 to 547. CONCLUSION: Although the rate of technical success may be somewhat lower and the rate of adverse events slightly higher than previously reported, our data suggest that POEM in octogenarians is safe and effective, supporting its role as a primary modality for achalasia in this patient population.

International multicenter comparative trial of endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for the treatment of malignant gastric outlet obstruction.

Background and study aims EUS-guided gastroenterostomy (EUS-GE) is a novel procedure that potentially offers long-lasting luminal patency without the risk of tumor ingrowth/overgrowth. This study compared the clinical success, technical success, adverse events (AEs), length of hospital stay (LOHS) and symptom recurrence in EUS-GE versus SGJ. Methods This was a multicenter international retrospective comparative study of EUS-GE and SGJ in patients with malignant gastric outlet obstruction (GOO) who underwent either EUS-GE or SGJ. EUS-GE was performed using lumen apposing metal stents. Results A total of 93 patients with malignant GOO treated with either EUS-GE (n = 30) or SGJ (n = 63) were identified. Peritoneal carcinomatosis was present in 13 (43 %) patients in the EUS-GE group and 7 (11 %) patients in the SGJ group (P < 0.001). Although the technical success rate was significantly higher in the SGJ group as compared to the EUS-GE group (100 % vs. 87 %, P = 0.009), the clinical success rate was not different (90 % vs. 87 %, P = 0.18, OR 0.8, 95 %CI 0.44 - 7.07). The rate of AEs was lower in the EUS-GE group, but the difference was not statistically significant (16 % vs 25 %, P = 0.3). The mean LOHS was similar in the EUS-GE group compared to SGJ (P = 0.35). The rate of recurrent GOO was not different between the two groups (3 % vs. 14 %, P = 0.08). Similarly, the mean time to reintervention was similar (88 days vs. 121 days, P = 0.83). Conclusions EUS-GE is associated with equivalent efficacy and safety as compared to surgical GJ. This is the first comparative trial between both techniques and suggests EUS-GE as a non-inferior but less invasive alter to surgery.

Endoscopic ultrasound-guided creation of a transgastric fistula for the management of hepatobiliary disease in patients with Roux-en-Y gastric bypass.

Background and aims Endoscopic retrograde cholangiopancreatography (ERCP) in patients who have undergone Roux-en-Y gastric bypass (RYGB) is technically challenging. We describe our multicenter experience using lumen-apposing metal stents (LAMSs) to create an endoscopic ultrasound-guided transgastric fistula (EUS-TG) to facilitate peroral ERCP in these patients. Patients and methods Thirteen patients with RYGB who underwent EUS-TG at three tertiary centers were included. EUS was used to guide puncture of the excluded stomach from the gastric pouch or jejunum; a LAMS was placed across the transgastric fistula. ERCP was performed via a duodenoscope passed through the LAMS. Results The technical success of EUS-TG was 100 % (13/13). ERCP through the LAMS was successful and clinical success was achieved in all patients. LAMS dislodgement during ERCP occurred in two patients and the stent was successfully repositioned without sequelae. After removal of the LAMS, the fistula was closed in 92 % of patients, either by endoscopic closure devices or argon plasma coagulation. None of the patients experienced procedure-related adverse events. Conclusion EUS-TG is an effective and safe method of accessing the excluded stomach and performing ERCP in patients with RYGB.

Endoscopic septotomy: an effective approach for internal drainage of sleeve gastrectomy-associated collections.

Background and study aims Staple-line leaks occur in 1 % - 7 % of patients who undergo sleeve gastrectomy, and can be challenging to treat. The success of endoscopic approaches decreases as leaks develop into chronic sinus tracts. Endoscopic septotomy has been used to facilitate healing of refractory leaks by incision and enlargement of the tract to allow direct communication with the gastric lumen and internal drainage. Patients and methods We reviewed the technique and outcomes among patients who underwent endoscopic septotomy at two centers for the management of sleeve gastrectomy-associated gastric fistulas and perigastric collections refractory to occlusive endoscopic therapies. Results Nine patients underwent endoscopic septotomy at a mean of 8.6 weeks after leak diagnosis, following failure of percutaneous and conventional endoscopic modalities. Perigastric collections ranged from 3 cm to 10 cm in size. The mean procedure time for endoscopic septotomy was 87.2 minutes. Multiple endoscopic septotomy procedures (mean 2.3, range 1 - 4) were required to achieve radiological resolution. The mean follow-up period was 21.2 weeks, and all nine patients achieved symptom resolution without the need for surgery. Bleeding at the time of endoscopic septotomy occurred in three patients, and was managed with endoscopic clips and did not require transfusion. No other adverse events or delayed complications were recorded. Conclusions Endoscopic septotomy appears to be a safe and effective technique for the management of sleeve gastrectomy-associated fistulae and collections, including those refractory to other endoscopic and percutaneous methods.

Similar Efficacies of Endoscopic Ultrasound Gallbladder Drainage With a Lumen-Apposing Metal Stent Versus Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis.

BACKGROUND & AIMS: Acute cholecystitis in patients who are not candidates for surgery is often managed with percutaneous transhepatic gallbladder drainage (PT-GBD). Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with a lumen-apposing metal stent (LAMS) is an effective alternative to PT-GBD. We compared the technical success of EUS-GBD versus PT-GBD, and patient outcomes, numbers of adverse events (AEs), length of hospital stay, pain scores, and repeat interventions. METHODS: We performed a retrospective study to compare EUS-GBD versus PT-GBD at 7 centers (5 in the United States, 1 in Europe, and 1 in Asia), from 2013 through 2015, in management of acute cholecystitis in patients who are not candidates for surgery. A total of 90 patients (56 men) with acute cholecystitis (61 calculous, 29 acalculous) underwent EUS-GBD (n = 45) or PT-GBD (n = 45). Data were collected on technical success, clinical success (resolution of symptoms or laboratory and/or radiologic abnormalities within 3 days of intervention), and need for repeat intervention. Characteristics were compared using Student t tests for continuous variables and the chi-square test, or the Fisher exact test, when appropriate, for categorical variables. Adverse events were graded according to American Society for Gastrointestinal Endoscopy definitions and compared using the Fisher exact test. Postprocedure pain scores were compared using the Mann-Whitney U test. RESULTS: Baseline characteristics, type, and clinical severity of cholecystitis were comparable between groups. In the EUS-GBD group, noncautery LAMS were used in 30 patients and cautery-enhanced LAMS were used in 15. Technical success was achieved for 98% of patients in the EUS-GBD and 100% of the patients in the PT-GBD group (P = .88). Clinical success was achieved by 96% of patients in the EUS-GBD group and 91% in the PT-GBD group (P = .20). There was a nonsignificant trend toward fewer AEs in the EUS-GBD group (5 patients; 11%) than in the PT-GBD group (14 patients; 32%) (P = .065). There were no significant differences in the severity of the AEs: mild, 2 in the EUS-GBD group versus 5 in the PT-GBD group (P = .27); moderate, 4 versus 3 (P = .98); severe, 1 versus 3 (P = .62); or deaths, 1 versus 3 (P = .61). The mean postprocedure pain score was lower in the EUS-GBD group than in the PT-GBD group (2.5 vs 6.5; P < .05). The EUS-GBD group had a shorter average length of stay in the hospital (3 days) than the PT-GBD group (9 days) (P < .05) and fewer repeat interventions (11 vs 112) (P < .05). The average number of repeat interventions per patients was 0.2 ± 0.4 EUS-GBD group versus 2.5 ± 2.8 in the PT-GBD group (P < .05). Median follow-up after drainage was comparable in EUS-GBD group (215 days; range, 1-621 days) versus the PT-GBD group (265 days; range, 1-1638 days). CONCLUSIONS: EUS-GBD has similar technical and clinical success compared with PT-GBD and should be considered an alternative for patients who are not candidates for surgery. Patients who undergo EUS-GBD seem to have shorter hospital stays, lower pain scores, and fewer repeated interventions, with a trend toward fewer AEs. A prospective, comparative study is needed to confirm these results.

Gastric per-oral endoscopic myotomy for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video).

BACKGROUND AND AIMS: Gastric per-oral endoscopic myotomy (G-POEM) recently has been reported as minimally invasive therapy for gastroparesis. The aims of this study were to report on the first multicenter experience with G-POEM and to assess the efficacy and safety of this novel procedure for patients with gastroparesis with symptoms refractory to medical therapy. METHODS: All patients with gastroparesis who underwent endoscopic pyloromyotomy (G-POEM) at 5 medical centers were included. Procedures were performed following the same principles as esophageal POEM. Clinical response was defined as improvement in gastroparetic symptoms with absence of recurrent hospitalization. Adverse events were graded according to the American Society for Gastrointestinal Endoscopy lexicon. RESULTS: A total of 30 patients with refractory gastroparesis (11 diabetic, 12 postsurgical, 7 idiopathic) underwent G-POEM. Previous therapies included Botox injection in 12, transpyloric stenting in 3, and PEG with jejunal extension (PEGJ) in 1. Nausea/vomiting were the predominant symptoms in 25 patients. Weight loss was present in 27 patients with an average of 10% loss of body weight. G-POEM was completed successfully in all 30 (100%) patients with a mean procedure time of 72 minutes (range, 35-223 min). The mean myotomy length was 2.6 ± 2.3 cm. The mean length of hospital stay was 3.3 days (range, 1-12 days). Two adverse events occurred in 2 (6.7%) patients, including 1 capnoperitoneum and 1 prepyloric ulcer, rated as mild and severe, respectively. Clinical response was observed in 26 (86%) patients during a median follow-up of 5.5 months. Four patients (2 diabetic, 1 postsurgical, 1 idiopathic cause) did not respond to G-POEM. Repeat gastric emptying scan was obtained in 17 patients, normalized in 8 (47%), and improved in 6 (35%) patients. CONCLUSION: G-POEM is a technically feasible procedure. This small non-randomized study suggests the effectiveness of G-POEM for the treatment of patients with gastroparesis refractory to medical therapy. It concomitantly results in normalization of GES in a significant proportion of treated patients.

Is POEM the Answer for Management of Spastic Esophageal Disorders? A Systematic Review and Meta-Analysis.

BACKGROUND AND AIMS: Spastic esophageal disorders (SEDs) include spastic achalasia (type III), diffuse esophageal spasm (DES), and nutcracker/jackhammer esophagus (JH). Per-oral endoscopic myotomy (POEM) has demonstrated efficacy and safety in the treatment of achalasia. Recently, POEM has been indicated for the treatment of SEDs. We conducted a systematic review and meta-analysis to determine the clinical success and safety of POEM in SEDs. METHODS: We searched several databases from 01/01/2007 to 01/10/2016 to identify studies (with five or more patients) on POEM for the treatment of SEDs. Weighted pooled rates (WPRs) for clinical success and adverse events (AEs) were calculated for all SEDs. Clinical success was defined as Eckardt scores of ≤3 and/or improvement in severity of dysphagia based on achalasia disease-specific health-related quality of life questionnaire. The WPRs for clinical success and AEs were analyzed using fixed- or random-effects model based on heterogeneity. The proportionate difference in clinical success and post-procedure adverse event rates among individual types of SEDs was also calculated. RESULTS: A total of eight observational studies with 179 patients were included in the final analysis. Two studies were of good quality and six were of fair quality based on the National Institutes of Health quality assessment tool. The WPR with 95% confidence interval (CI) for cumulative clinical success of POEM in all SEDs was 87% (78, 93%), I 2 = 37%. The total number of patients for individual disorders, i.e., type III achalasia, JH, and DES, was 116, 37, and 18, respectively. The WPRs for clinical success of POEM for type III achalasia, DES, and JH were 92, 88, and 72%, respectively. Proportion difference of WPR for clinical success was significantly higher for type III achalasia in comparison with JH (20%, P = 0.01). The WPR with 95% CI for AEs of POEM in all SEDs was 14% (9, 20%), I 2 = 0%. The WPRs for post-procedure adverse events for type III achalasia, DES, and JH were 11, 14, and 16%, respectively. There was no difference in safety of POEM among individual SEDs. CONCLUSION: POEM is an effective and safe therapeutic modality for the treatment of spastic esophageal disorders.

Upper esophageal sphincter abnormalities are strongly predictive of treatment response in patients with achalasia.

AIM: To investigate the relationship between upper esophageal sphincter abnormalities achalasia treatment METHODS: We performed a retrospective study of 41 consecutive patients referred for high resolution esophageal manometry with a final manometric diagnosis of achalasia. Patients were sub-divided by presence or absence of Upper esophageal sphincter (UES) abnormality, and clinical and manometric profiles were compared. Correlation between UES abnormality and sub-type (i.e., hypertensive, hypotensive or impaired relaxation) and a number of variables, including qualitative treatment response, achalasia sub-type, co-morbid medical illness, psychiatric illness, surgical history, dominant presenting symptom, treatment type, age and gender were also evaluated. RESULTS: Among all 41 patients, 24 (58.54%) had a UES abnormality present. There were no significant differences between the groups in terms of age, gender or any other clinical or demographic profiles. Among those with UES abnormalities, the majority were either hypertensive (41.67%) or had impaired relaxation (37.5%) as compared to hypotensive (20.83%), although this did not reach statistical significance (P = 0.42). There was no specific association between treatment response and treatment type received; however, there was a significant association between UES abnormalities and treatment response. In patients with achalasia and concomitant UES abnormalities, 87.5% had poor treatment response, while only 12.5% had favorable response. In contrast, in patients with achalasia and no UES abnormalities, the majority (78.57%) had good treatment response, as compared to 21.43% with poor treatment response (P = 0.0001). After controlling for achalasia sub-type, those with UES abnormality had 26 times greater odds of poor treatment response than those with no UES abnormality (P = 0.009). Similarly, after controlling for treatment type, those with UES abnormality had 13.9 times greater odds of poor treatment response compared to those with no UES abnormality (P = 0.017). CONCLUSION: The presence of UES abnormalities in patients with achalasia significantly predicted poorer treatment response as compared to those with normal UES function.