Management of patients after failed peroral endoscopic myotomy: a multicenter study.

BACKGROUND: Although peroral endoscopic myotomy (POEM) is highly effective for the management of achalasia, clinical failures may occur. The optimal management of patients who fail POEM is not well known. This study aimed to compare the outcomes of different management strategies in patients who had failed POEM. METHODS: This was an international multicenter retrospective study at 16 tertiary centers between January 2012 and November 2019. All patients who underwent POEM and experienced persistent or recurrent symptoms (Eckardt score > 3) were included. The primary outcome was to compare the rates of clinical success (Eckardt score ≤ 3) between different management strategies. RESULTS : 99 patients (50 men [50.5 %]; mean age 51.4 [standard deviation (SD) 16.2]) experienced clinical failure during the study period, with a mean (SD) Eckardt score of 5.4 (0.3). A total of 29 patients (32.2 %) were managed conservatively and 70 (71 %) underwent retreatment (repeat POEM 33 [33 %], pneumatic dilation 30 [30 %], and laparoscopic Heller myotomy (LHM) 7 [7.1 %]). During a median follow-up of 10 (interquartile range 3 - 20) months, clinical success was highest in patients who underwent repeat POEM (25 /33 [76 %]; mean [SD] Eckardt score 2.1 [2.1]), followed by pneumatic dilation (18/30 [60 %]; Eckardt score 2.8 [2.3]), and LHM (2/7 [29 %]; Eckardt score 4 [1.8]; P = 0.12). A total of 11 patients in the conservative group (37.9 %; mean Eckardt score 4 [1.8]) achieved clinical success. CONCLUSION : This study comprehensively assessed an international cohort of patients who underwent management of failed POEM. Repeat POEM and pneumatic dilation achieved acceptable clinical success, with excellent safety profiles.

Treatment experience with a novel 30-mm hydrostatic balloon in esophageal dysmotility: a multicenter retrospective analysis.

BACKGROUND AND AIMS: The newest addition in the management of achalasia and esophagogastric junction outflow obstruction (EGJOO) is a 30-mm hydrostatic balloon dilator that uses impedance planimetry technology. It allows for the measurement of the diameter and cross-sectional area to determine effective dilation. We aimed to (1) determine the clinical success (defined as a decrease in Eckardt score to ≤3) in the treatment of esophageal motility disorders and (2) report the safety (rate/severity of adverse events). METHODS: This retrospective multicenter study involved 4 centers. Patients with esophageal motility disorders who underwent hydrostatic balloon dilation between January 2015 and October 2018 were included. RESULTS: Fifty-one patients (mean age, 54.1 years; women, 49%) underwent hydrostatic dilation for achalasia (n = 37) or EGJOO (n = 14) during the study period. Forty-seven patients had a median baseline Eckardt score of 5 (range, 3-8; achalasia, n = 35, 6 [range, 3-8]; EGJOO, n = 12, 4 [range, 3.25-6.5]). Clinical success was achieved in 60% of cases (achalasia vs EGJOO: 68.4% vs 33.3%, P = .18). Dilation resulted in a significant decrease in the median Eckardt score from 5 (range, 3-8) to 1.5 (range, 1-4.75; P < .001). Patients with achalasia had a decrease in Eckardt score from 6 (range, 3-8) to 1 (range, 1-4; P < .001), whereas those with EGJOO experienced no significant change. One patient had mild postprocedure chest pain. CONCLUSIONS: The hydrostatic balloon dilator is a new tool in our armamentarium to treat esophageal motility disorders. This is the first multicenter study showing the device to be safe and moderately efficacious.

Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) has become the mainstay for the treatment of achalasia at many institutions around the world since its inception in 2008. POEM can be performed using either the anterior or posterior approach. The primary aim of this study was to compare the efficacy of the anterior and posterior approaches at 1 year after POEM. METHODS: This is a single-blinded, randomized, noninferiority international clinical trial. Eligible participants were adult patients with a confirmed diagnosis of achalasia via high-resolution esophageal manometry. Patients were randomly allocated with a 1:1 ratio to receive POEM with anterior or posterior approach. The primary aim was to compare the rate of clinical success (Eckardt score <3) of anterior and posterior approaches at 1 year. RESULTS: One hundred fifty patients were randomized to receive either anterior (n = 73) or posterior (n = 77) POEM. One hundred forty-eight patients received the POEM treatment, and 138 patients completed the 1-year follow-up and were included in the primary efficacy analysis. Technical success was achieved in 71 patients (97.3%) in the anterior group versus 77 patients (100%) in the posterior group (P = .23). The median (interquartile range) length of hospital stay after the procedure was 2 (1-3) days for both groups. Adverse events occurred in 15 patients (10%), 8 patients (11%) in the anterior group and 7 patients (9%) in the posterior group (P = .703). Clinical success was achieved in 90% of patients in the anterior group and 89% of patients in the posterior group. Abnormal esophageal acid exposure was detected in 29 of 59 patients (49%) and 25 of 60 patients (42%) in the anterior and posterior groups, respectively (P = .67). GERD questionnaire scores were also not significantly different between the study groups. In both groups, quality of life improved after POEM for all 36-Item Short-Form Health Survey measures and was similar between both groups. CONCLUSIONS: Posterior myotomy during POEM was not inferior to anterior myotomy in terms of efficacy and safety in the treatment of patients with achalasia. (Clinical trial registration number: NCT02454335.).

Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss.

BACKGROUND & AIMS: Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon. METHODS: We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB was removed after 6 months. We collected data (demographic, medical, and laboratory) from 202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8 + 8.4 kg/m2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure. RESULTS: Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal. CONCLUSION: In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months.

Cost-effectiveness analysis comparing lumen-apposing metal stents with plastic stents in the management of pancreatic walled-off necrosis.

BACKGROUND AND AIMS: EUS-guided transmural drainage is effective in the management of pancreatic walled-off necrosis (WON). A lumen-apposing metal stent (LAMS) has recently been developed specifically for the drainage of pancreatic fluid collections that shows promising results. However, no cost-effectiveness data have been published in comparison with endoscopic drainage with traditional plastic stents (PSs). Our aim here was to compare the cost-effectiveness of LAMSs to PSs in the management of WON. METHODS: A decision tree was developed to assess both LAMSs and PSs over a 6-month time horizon. For each strategy, after the insertion of the respective stents, patients were followed for subsequent need for direct endoscopic necrosectomy, adverse events requiring unplanned endoscopy, percutaneous drainage (PCD), or surgery using probabilities obtained from the literature. The unit of effectiveness was defined as successful endoscopic drainage without the need for PCD or surgery. Costs in 2016 U.S.$ were based on inpatient institutional costs. Sensitivity analyses were performed. An a priori willingness-to-pay threshold of U.S.$50,000 was established. RESULTS: LAMSs were found to be more efficacious than PSs, with 92% and 84%, respectively, of the patients achieving successful endoscopic drainage of WON. LAMSs, however, were more costly: the average cost per patient of U.S.$20,029 compared with U.S.$15,941 for PSs. The incremental cost-effectiveness ratio favored LAMSs at U.S.$49,214 per additional patient successfully treated. Sensitivity analyses confirmed the robustness of the results. CONCLUSION: LAMSs are more effective but also more costly than PSs in managing WON. Data from high-quality, adequately controlled, prospective, randomized trials are needed to confirm our findings.

Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial.

BACKGROUND AND STUDY AIM: Standard endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) procedures involve use of no-suction or suction aspiration techniques. A new aspiration method, the stylet slow-pull technique, involves slow withdrawal of the needle stylet to create minimum negative pressure. The aim of this study was to compare the sensitivity of EUS-FNA using stylet slow-pull or suction techniques for malignant solid pancreatic lesions using a standard 22-gauge needle. PATIENTS AND METHODS: Consecutive patients presenting for EUS-FNA of pancreatic mass lesions were randomized to the stylet slow-pull or suction techniques using a 22-gauge needle. Both techniques were standardized for each pass until an adequate specimen was obtained, as determined by rapid on-site cytology examination. Patients were crossed over to the alternative technique after four nondiagnostic passes. RESULTS: Of 147 patients screened, 121 (mean age 64 ±â€Š13.8 years) met inclusion criteria and were randomized to the stylet slow-pull technique (n = 61) or the suction technique (n = 60). Technical success rates were 96.7 % and 98.3 % in the slow-pull and suction groups, respectively (P > 0.99). The sensitivity for malignancy of EUS-FNA was 82 % in the slow-pull group and 69 % in the suction group (P = 0.10). The first-pass diagnostic rate (42.6 % vs. 38.3 %; P = 0.71), acquisition of core tissue (60.6 % vs. 46.7 %; P = 0.14), and the median (range) number of passes to diagnosis (2 1 2 3 vs. 1 1 2; P = 0.71) were similar in the slow-pull and suction groups, respectively. CONCLUSIONS: The stylet slow-pull and suction techniques both offered high and comparable diagnostic sensitivity with a mean of 2 passes required for diagnosis of solid pancreatic lesions. The endosonographer may choose either technique during FNA.

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.

Gastroesophageal reflux after peroral endoscopic myotomy: a multicenter case-control study.

Background and study aims The variables associated with gastroesophageal reflux (GER) after peroral endoscopic myotomy (POEM) are largely unknown. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GER in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GER. Patients and methods All patients who underwent POEM and subsequent objective testing for GER (pH study with or without upper gastrointestinal [GI] endoscopy) at seven tertiary academic centers (one Asian, two US, four European) were included. Patients were divided into two groups: 1) DeMeester score ≥ 14.72 (cases) and 2) DeMeester score of < 14.72 (controls). Asymptomatic GER was defined as a patient with a DeMeester score ≥ 14.72 who was not consuming proton pump inhibitor (PPI). Results A total of 282 patients (female 48.2 %, Caucasian 84.8 %; mean body mass index 24.1 kg/m2) were included. Clinical success was achieved in 94.3 % of patients. GER evaluation was completed after a median follow-up of 12 months (interquartile range 10 - 24 months). A DeMeester score of ≥ 14.72 was seen in 57.8 % of patients. Multivariable analysis revealed female sex to be the only independent association (odds ratio 1.69, 95 % confidence interval 1.04 - 2.74) with post-POEM GER. No intraprocedural variables were associated with GER. Upper GI endoscopy was available in 233 patients, 54 (23.2 %) of whom were noted to have reflux esophagitis (majority Los Angeles Grade A or B). GER was asymptomatic in 60.1 %. Conclusion Post-POEM GER was seen in the majority of patients. No intraprocedural variables were identified to allow for potential alteration in procedural technique.

A multicenter experience of through-the-scope balloon-assisted enteroscopy in surgically altered gastrointestinal anatomy.

BACKGROUND: Surgically altered gastrointestinal anatomy poses challenges for deep enteroscopy. Current overtube-assisted methods have long procedure times and utilize endoscopes with smaller working channels that preclude use of standard accessories. A through-the-scope balloon-assisted enteroscopy (TTS-BAE) device uses standard endoscopes with a large working channel to allow metallic and plastic stent insertion. We aim to determine the efficacy and safety of TTS-BAE in patients with altered surgical anatomy. METHODS: A retrospective, multicenter study of TTS-BAE in altered anatomy patients at two USA and one German institution was performed between January 2013 and December 2014. Type of anatomy, procedure indication and duration, adverse events, and target, technical, and clinical success were recorded. RESULTS: A total of 32 patients (mean age 54 years, Caucasian 81.6%, female 42.1%, mean BMI 25.4 kg/m2) underwent 38 TTS-BAE procedures. Thirty-two percent of cases had a prior attempt at conventional enteroscopy which failed to reach the target site. The target was successfully reached in 23 (60.5%) cases. Of the 23 cases that reached the intended target, 22 (95.7%) achieved technical success and 21 (91.3%) achieved clinical success. The median procedure time was 43 min. Target, technical, and clinical success rates for TTS-BAE-assisted ERCP (n = 31) were 58.1, 54.8 and 54.8%. Seven self-expandable metallic stents (five biliary, two jejunal) were attempted, and all successfully deployed. Adverse events occurred in 4 (10.4%) cases, including one luminal perforation. CONCLUSION: TTS-BAE is an alternative to overtube-assisted enteroscopy that is comparable in safety in patients with surgically altered anatomies. Technical success in the instances where the target had been reached was excellent. TTS-BAE confers an advantage over overtube-assisted enteroscopy as it can facilitate the deployment of self-expandable metallic stents in the biliary tree and deep small bowel.

Comprehensive analysis of efficacy and safety of peroral endoscopic myotomy performed by a gastroenterologist in the endoscopy unit: a single-center experience.

BACKGROUND AND AIMS: The safety and efficacy of peroral endoscopic myotomy (POEM) when performed by gastroenterologists in the endoscopy unit are currently unknown. The aims of this study were to assess (1) the safety and efficacy of POEM in which all procedures were performed by 1 gastroenterologist in the endoscopy unit, and (2) the predictors of adverse events and nonresponse. METHODS: All consecutive patients who underwent POEM at 1 tertiary center were included. Clinical response was defined by a decrease in the Eckardt score to 3 or lower. Adverse events were graded according to the American Society for Gastrointestinal Endoscopy lexicon's severity grading system. RESULTS: A total of 60 consecutive patients underwent POEM in the endoscopy suite with a mean procedure length of 99 minutes. The mean length of submucosal tunnel was 14 cm and the mean myotomy length was 11 cm. The median length of hospital stay was 1 day. Among 52 patients with a mean follow-up period of 118 days (range 30-750), clinical response was observed in 48 patients (92.3%). There was a significant decrease in Eckardt score after POEM (8 vs 1.19, P < .0001). The mean lower esophageal sphincter pressure decreased significantly after POEM (29 mm Hg vs 11 mm Hg, P < .0001). A total of 10 adverse events occurred in 10 patients (16.7%): 7 rated as mild, 3 as moderate, and none as severe. Procedure length was the only predictor of adverse events (P = .01). pH impedance testing was completed in 25 patients, and 22 (88%) had abnormal acid exposure, but positive symptom correlation was present in only 6 patients. All patients with symptomatic reflux were successfully treated with proton pump inhibitors. CONCLUSIONS: POEM can be effectively and safely performed by experienced gastroenterologists at a tertiary care endoscopy unit. Adverse events are infrequent, and most can be managed intraprocedurally. Post-POEM reflux is frequent but can be successfully managed medically.

Transpapillary drainage has no added benefit on treatment outcomes in patients undergoing EUS-guided transmural drainage of pancreatic pseudocysts: a large multicenter study.

BACKGROUND AND AIMS: The need for transpapillary drainage (TPD) in patients undergoing transmural drainage (TMD) of pancreatic fluid collections (PFCs) remains unclear. The aims of this study were to compare treatment outcomes between patients with pancreatic pseudocysts undergoing TMD versus combined (TMD and TPD) drainage (CD) and to identify predictors of symptomatic and radiologic resolution. METHODS: This is a retrospective review of 375 consecutive patients with PFCs who underwent EUS-guided TMD from 2008 to 2014 at 15 academic centers in the United States. Main outcome measures included TMD and CD technical success, treatment outcomes (symptomatic and radiologic resolution) at follow-up, and predictors of treatment outcomes on logistic regression. RESULTS: A total of 375 patients underwent EUS-guided TMD of PFCs, of which 174 were pseudocysts. TMD alone was performed in 95 (55%) and CD in 79 (45%) pseudocysts. Technical success was as follows: TMD, 92 (97%) versus CD, 35 (44%) (P = .0001). There was no difference in adverse events between the TMD (15%) and CD (14%) cohorts (P = .23). Median long-term (LT) follow-up after transmural stent removal was 324 days (interquartile range, 72-493 days) for TMD and 201 days (interquartile range, 150-493 days) (P = .37). There was no difference in LT symptomatic resolution (TMD, 69% vs CD, 62%; P = .61) or LT radiologic resolution (TMD, 71% vs CD, 67%; P = .79). TPD attempt was negatively associated with LT radiologic resolution of pseudocyst (odds ratio, 0.11; 95% confidence interval, 0.02-0.8; P = .03). CONCLUSIONS: TPD has no benefit on treatment outcomes in patients undergoing EUS-guided TMD of pancreatic pseudocysts and negatively affects LT resolution of PFCs.

Endoscopic suturing for the prevention of stent migration in benign upper gastrointestinal conditions: a comparative multicenter study.

BACKGROUND AND STUDY AIMS: Fully covered self-expandable metal stents (FCSEMSs) have increasingly been used in benign upper gastrointestinal (UGI) conditions; however, stent migration remains a major limitation. Endoscopic suture fixation (ESF) may prevent stent migration. The aims of this study were to compare the frequency of stent migration in patients who received endoscopic suturing for stent fixation (ESF group) compared with those who did not (NSF group) and to assess the impact of ESF on clinical outcome. PATIENTS AND METHODS: This was a retrospective study of patients who underwent FCSEMS placement for benign UGI diseases. Patients were divided into either the NSF or ESF group. Outcome variables, including stent migration, clinical success (resolution of underlying pathology), and adverse events, were compared. RESULTS: A total of 125 patients (44 in ESF group, 81 in NSF group; 56 benign strictures, 69 leaks/fistulas/perforations) underwent 224 stenting procedures. Stent migration was significantly more common in the NSF group (33 % vs. 16 %; P = 0.03). Time to stent migration was longer in the ESF group (P = 0.02). ESF appeared to protect against stent migration in patients with a history of stent migration (adjusted odds ratio [OR] 0.09; P = 0.002). ESF was also significantly associated with a higher rate of clinical success (60 % vs. 38 %; P = 0.03). Rates of adverse events were similar between the two groups. CONCLUSIONS: Endoscopic suturing for stent fixation is safe and associated with a decreased migration rate, particularly in patients with a prior history of stent migration. It may also improve clinical response, likely because of the reduction in stent migration.

Intraoperative measurement of esophagogastric junction cross-sectional area by impedance planimetry correlates with clinical outcomes of peroral endoscopic myotomy for achalasia: a multicenter study.

BACKGROUND: Peroral endoscopic myotomy (POEM) has been introduced as an endoscopic alternative to surgical myotomy. The endoluminal functional lumen imaging probe (endoFLIP) evaluates esophagogastric junction (EGJ) distensibility based on cross-sectional area and pressure in response to volume distension. The aim of this study was to evaluate whether there is a correlation between endoFLIP measurements during POEM and postoperative clinical outcomes in terms of symptom relief and development of post-procedure reflux. METHODS: We conducted a retrospective review of achalasia patients who underwent POEM and intraoperative endoFLIP at three tertiary centers. Patients were divided into two groups based on clinical response measured by Eckardt score (ES): good response (ES < 3) or poor response (ES ≥ 3). Post-procedure reflux was defined as the presence of esophagitis and/or abnormal pH study. EGJ diameter, cross-sectional area, and distensibility measured by endoFLIP were compared. RESULTS: Of the 63 treated patients, 50 had good and 13 had poor clinical response. The intraoperative final EGJ cross-sectional area was significantly higher in the good-response group versus poor-response group; median (interquartile range): 89.0 (78.5-106.7) versus 72.4 (48.8-80.0) mm(2) [p = 0.01]. The final EGJ cross-sectional area was also significantly higher in patients who had reflux esophagitis after POEM: 99.5 (91.2-103.7) versus 79.3 (57.1-94.2) mm(2) [p = 0.02]. CONCLUSION: Intraoperative EGJ cross-sectional area during POEM for achalasia correlated with clinical response and post-procedure reflux. Impedance planimetry is a potentially important tool to guide the extent and adequacy of myotomy during POEM.

Interventional EUS Using a Flexible 19-Gauge Needle: An International Multicenter Experience in 162 Patients.

BACKGROUND AND AIMS: To facilitate access for interventional EUS, flexible (nitinol) 19-G needles have been introduced to permit needle puncture even when the echoendoscope is in an angulated position, such as in the second part of the duodenum. The aims of the study were to evaluate the performance of a flexible 19-G needle during interventional EUS procedures and compare outcomes when the echoendoscope was in the straight versus angulated position. METHODS: A retrospective review was undertaken of 162 consecutive patients that underwent a variety of interventional EUS procedures with a flexible 19-G needle across five centers. Patients were subdivided into categories (straight or angulated) depending on the echoendoscope position used for obtaining access to the area of interest (Fig. 1). Fig. 1 Flexible 19-G needle design. a The needle is able to exit the sheath despite the rotated position. b The needle beveled needle tip RESULTS: In the entire cohort, needle-specific technical success was achieved in 93.2 %, procedural success in 85.2 %, and overall clinical success in 76.5 % of cases at a mean follow-up of 3.1 months. Needle-specific technical success was similar between the straight and angulated cohorts (94.0 vs. 91.2 %, p = 0.74). Procedural success (86.7 vs. 77.2 %, p = 0.05), and rate of clinical success was similar between the cohorts (83.3 vs. 86.4 %, p = 0.79), respectively. Overall adverse events were noted in 14.2 % of patients with no difference between the straight and angulated cohorts (p = 0.48). CONCLUSIONS: This study demonstrates equivalent technical success, clinical success and safety of using a flexible 19-G needle in straight and angulated endoscope positions for interventional EUS. Therefore, a flexible needle may be considered where an angulated echoendoscope position is encountered.

EUS-guided gastroenterostomy: the first U.S. clinical experience (with video).

BACKGROUND AND AIMS: There are limitations to enteral self-expandable metal stents and surgical gastrojejunostomy in the treatment of patients with gastric outlet obstruction (GOO). EUS-guided gastroenterostomy (EUS-GE) is a novel procedure that potentially offers long-lasting luminal patency without the risk of tumor ingrowth and/or overgrowth, while avoiding the morbidity of a surgical procedure. The aims of this study were to report the first U.S. clinical experience with EUS-GE in terms of technical success, clinical success, and adverse events and to detail the technical aspects of performing EUS-GE. METHODS: This was a retrospective study from two tertiary-care centers. EUS-GE was performed by using either the direct EUS-GE or balloon-assisted EUS-GE technique. Technical success was defined as adequate positioning and deployment of the stent as determined endoscopically and radiologically. Clinical success was defined as the patient's ability to tolerate oral intake without vomiting. RESULTS: A total of 10 patients underwent attempted EUS-GE. Malignant GOO was present in 3 patients, whereas benign obstruction was found in the remaining 7. One patient had complete GOO and underwent successful direct EUS-GE. In the remaining 9 patients, balloon-assisted EUS-GE was attempted and was successful in 8. Thus, technical success occurred in 9 patients (90%). There were no procedure-related adverse events. Mean procedure time was 96 minutes (range 45-152 minutes), and mean length of hospital stay was 2.2 days. Clinical success with resumption of solid oral intake was achieved in all 9 patients (100%) who underwent successful EUS-GE. A total of 8 patients were able to tolerate almost a normal diet and/or full diet, and 1 patient tolerated a soft diet. There was no symptom recurrence during a mean follow-up period of 150 days. CONCLUSIONS: EUS-GE is a promising new technique for the treatment of symptoms of benign and malignant GOO. Prospective, multicenter trials are needed to confirm these results.

Refractory gastroparesis can be successfully managed with endoscopic transpyloric stent placement and fixation (with video).

BACKGROUND AND AIMS: Medical treatment options for gastroparesis are limited. Data from studies of botulinum toxin and surgical pyloroplasty suggest that disruption of the pylorus can result in symptomatic improvement in some patients with refractory gastroparetic symptoms. The aim of this study was to determine the clinical response to transpyloric stent (TPS) placement in patients with gastroparetic symptoms refractory to standard therapy. METHODS: Patients with gastroparesis refractory to medical treatment were referred for TPS placement for salvage therapy. Self-reported symptom improvement, stent migration rate, and pre- and post-stent gastric-emptying study results were collected. RESULTS: A total of 30 patients with refractory gastroparesis underwent 48 TPS procedures. Of these, 25 of 48 (52.1%) were performed in patients admitted to the hospital with intractable gastroparetic symptoms. Successful stent placement in the desired location across the pylorus (technical success) was achieved during 47 procedures (98%). Most (n = 24) stents were anchored to the gastric wall by using endoscopic suturing with a mean number of sutures of 2 (range 1-3) per procedure. Clinical response was observed in 75% of patients, and all inpatients were successfully discharged. Clinical success in patients with the predominant symptoms of nausea and vomiting was higher than in those patients with a predominant symptom of pain (79% vs 21%, P = .12). A repeat gastric-emptying study was performed in 16 patients, and the mean 4-hour gastric emptying normalized in 6 patients and significantly improved in 5 patients. Stent migration was least common (48%) when stents were sutured. CONCLUSION: TPS placement is a feasible novel endoscopic treatment modality for gastroparesis and improves both symptoms and gastric emptying in patients who are refractory to medical treatment, especially those with nausea and vomiting. TPS placement may be considered as salvage therapy for inpatients with intractable symptoms or potentially as a method to select patients who may respond to more permanent therapies directed at the pylorus.

International multicenter experience with peroral endoscopic myotomy for the treatment of spastic esophageal disorders refractory to medical therapy (with video).

BACKGROUND: Limited data exist on the use of peroral endoscopic myotomy (POEM) for therapy of spastic esophageal disorders (SEDs). OBJECTIVE: To study the efficacy and safety of POEM for the treatment of patients with diffuse esophageal spasm, jackhammer esophagus, or type III (spastic) achalasia. DESIGN: Retrospective study. SETTING: International, multicenter, academic institutions. PATIENTS: All patients who underwent POEM for treatment of SEDs refractory to medical therapy at 11 centers were included. INTERVENTIONS: POEM. MAIN OUTCOME MEASUREMENTS: Eckardt score and adverse events. RESULTS: A total of 73 patients underwent POEM for treatment of SEDs (diffuse esophageal spasm 9, jackhammer esophagus 10, spastic achalasia 54). POEM was successfully completed in all patients, with a mean procedural time of 118 minutes. The mean length of the submucosal tunnel was 19 cm, and the mean myotomy length was 16 cm. A total of 8 adverse events (11%) occurred, with 5 rated as mild, 3 moderate, and 0 severe. The mean length of hospital stay was 3.4 days. There was a significant decrease in Eckardt scores after POEM (6.71 vs 1.13; P = .0001). Overall, clinical response was observed in 93% of patients during a mean follow-up of 234 days. Chest pain significantly improved in 87% of patients who reported chest pain before POEM. Repeat manometry after POEM was available in 44 patients and showed resolution of initial manometric abnormalities in all cases. LIMITATIONS: Retrospective design and selection bias. CONCLUSION: POEM offers a logical therapeutic modality for patients with SEDs refractory to medical therapy. Results from this international study suggest POEM as an effective and safe platform for these patients.

Iatrogenic pharyngoesophageal perforations treated with fully covered self-expandable metallic stents (with video).

BACKGROUND: Iatrogenic pharyngoesophageal perforations are a rare but serious complication of endoscopy. Surgical and non-surgical approaches have been reported but result in a significant morbidity and extended hospital stay. Therefore, an unmet need exists for an alternative management technique. We demonstrate a new endoscopic approach for the management of iatrogenic pharyngoesophageal perforations through the use of esophageal fully covered self-expandable metallic stents (FCSEMS). PATIENTS AND METHODS: Two patients who underwent flexible endoscopy each suffered a large iatrogenic perforation detected intraprocedurally. After emergency intubation, an esophageal FCSEMS was deployed in the hypopharynx and the patient admitted to the intensive care unit. On day 3, the patients underwent an esophagogastroduodenoscopy with stent removal. RESULTS: There was complete closure of the perforations on day 3. The patients were extubated and subsequently tolerated a soft diet. The patients were discharged home on day 4. CONCLUSIONS: The placement of a removable FCSEMS in the setting of an acutely diagnosed perforation may be a suitable minimally invasive approach for the management of iatrogenic pharyngoesophageal perforations.

A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP.

BACKGROUND AND AIM: Endoscopic ultrasound-guided biliary drainage (EGBD) may be a safe, alternative technique to percutaneous transhepatic biliary drainage (PTBD) in patients who fail ERCP. However, it is currently unknown how both techniques compare in terms of efficacy, safety, and cost. The aims of this study were to compare efficacy, safety, and cost of EGBD to that of PTBD. METHODS: Jaundiced patients with distal malignant biliary obstruction who underwent EGBD or PTBD after failed ERCP were included. Technical success, clinical success, and adverse events between the two groups were compared. RESULTS: A total of 73 patients with failed ERCP subsequently underwent EGBD (n = 22) or PTBD (n = 51). Although technical success was higher in the PTBD group (100 vs. 86.4 %, p = 0.007), clinical success was equivalent (92.2 vs. 86.4 %, p = 0.40). PTBD was associated with higher adverse event rate (index procedure: 39.2 vs. 18.2 %; all procedures including reinterventions: 80.4 vs. 15.7 %). Stent patency and survival were equivalent between both groups. Total charges were more than two times higher in the PTBD group (p = 0.004) mainly due to significantly higher rate of reinterventions (80.4 vs. 15.7 %, p < 0.001). CONCLUSION: EGBD and PTBD are comparably effective techniques for treatment of distal malignant biliary obstruction after failed ERCP. However, EGBD is associated with decreased adverse events rate and is significantly less costly due to the need for fewer reinterventions. Our results suggest that EGBD should be the technique of choice for treatment of these patients at institutions with experienced interventional endosonographers.

The role of ultrasound in the follow-up of children with differentiated thyroid cancer.

BACKGROUND: Thyroid cancer is the most common endocrine malignancy with relatively good prognosis in children. However, unlike adults, children usually present with more advanced disease and have a higher local recurrence and distant metastases. Thus surveillance for recurrence is a major goal of long-term follow-up. OBJECTIVE: This retrospective study evaluates the diagnostic value of ultrasound (US) imaging in the post-therapy surveillance of children with differentiated thyroid cancer. MATERIALS AND METHODS: We reviewed the charts of 54 children (40 girls; mean age 14.3 ± 3.6 years) with differentiated thyroid cancer treated with total or near-total thyroidectomy. Forty children (29 girls and 11 boys) who had routine follow-up US examinations (112 studies) were included for the evaluation of US accuracy in the follow-up of pediatric differentiated thyroid cancer. Histopathology, stimulated thyroglobulin determination, post-therapy whole-body iodine scan and clinical follow-up were used as the standards of reference. RESULTS: Mean period of follow-up was 34 months. The frequency of recurrence was 42% (17/40). Seventeen percent of the children had lung metastases either at presentation or on follow-up. In all cases of lung metastases, stimulated thyroglobulin level was greater than 10 ng/ml. The sensitivity was 85.7%, specificity 89.4%, negative predictive value 94.4% and positive predictive value 75% for US in detecting loco-regional recurrence in follow-up studies of pediatric differentiated thyroid cancer. In 17.3% (18/104) of studies, the results of stimulated thyroglobulin and US were discordant. CONCLUSION: US showed very good sensitivity and specificity and a high negative predictive value for evaluation of loco-regional involvement in follow-up of pediatric differentiated thyroid cancer. Diagnostic whole-body iodine scan is indicated when serum anti-thyroglobulin Ab is high, or in cases of discordant findings between US and stimulated thyroglobulin levels, or when stimulated thyroglobulin levels are >10 ng/ml (to evaluate for lung metastasis).