Peroral endoscopic myotomy: 10-year outcomes from a large, single-center U.S. series with high follow-up completion and comprehensive analysis of long-term efficacy, safety, objective GERD, and endoscopic functional luminal assessment.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) is becoming the treatment of choice for achalasia. Data beyond 3 years are emerging but are limited. We herein report our 10-year experience, focusing on long-term efficacy and safety including the prevalence, management, and sequelae of postoperative reflux. METHODS: This was a single-center prospective cohort study. RESULTS: Six hundred ten consecutive patients received POEM from October 2009 to October 2019, 160 for type 1 achalasia (26.2%), 307 for type II (50.3%), 93 for type III (15.6%), 25 for untyped achalasia (4.1%), and 23 for nonachalasia disorders (3.8%). Two hundred ninety-two patients (47.9%) had prior treatment(s). There was no aborted POEM. Median operation time was 54 minutes. Accidental mucosotomies occurred in 64 patients (10.5%) and clinically significant adverse events in 21 patients (3.4%). No adverse events led to death, surgery, interventional radiology interventions/drains, or altered functional status. At a median follow-up of 30 months, 29 failures occurred, defined as postoperative Eckardt score >3 or need for additional treatment. The Kaplan-Meier clinical success estimates at years 1, 2, 3, 4, 5, 6, and 7 were 98%, 96%, 96%, 94%, 92%, 91%, and 91%, respectively. These are highly accurate estimates because only 13 patients (2%) were missing follow-up assessments. One hundred twenty-five patients (20.5%) had reflux symptoms more than once per week. At a median of 4 months, the pH study was completed in 406 patients (66.6%) and was positive in 232 (57.1%), and endoscopy was completed in 438 patients (71.8%) and showed reflux esophagitis in 218 (49.8%), mostly mild. CONCLUSIONS: POEM is exceptionally safe and highly effective on long-term follow-up, with >90% clinical success at ≥5 years.

Per-oral endoscopic myotomy in patients with or without prior Heller's myotomy: comparing long-term outcomes in a large U.S. single-center cohort (with videos).

BACKGROUND AND AIMS: Heller's myotomy (HM) is one of the most effective treatments for esophageal achalasia. However, failures do exist, and the success rate tends to decrease with time. The efficacy of rescue treatments for patients with failed HM is limited. A few small-scale studies have reported outcomes of per-oral endoscopic myotomy (POEM) in these patients. We conducted this study to systematically assess feasibility, safety, and efficacy of POEM on patients who have had HM. METHODS: Patients at least 3 months out from POEM were selected from our prospective database: 318 consecutive POEMs performed from October 2009 to October 2016. The efficacy and safety of POEM were compared between the 46 patients with prior HM and the remaining 272 patients. RESULTS: Patients with prior HM had longer disease history, more advanced disease, more type I and less type II achalasia, lower before-POEM Eckardt scores, and lower before-POEM lower esophageal sphincter (LES) pressure (all P < .01). Procedure parameters and follow-up results (clinical success rate, Eckardt score, LES pressure, GERD score, esophagitis, and pH testing) showed no significant difference between the 2 groups. For the 46 HM-POEM patients, no clinically significant perioperative adverse events occurred. Their overall clinical success rate (Eckardt score ≤3 and no other treatment needed) was 95.7% at a median follow-up of 28 months. CONCLUSION: POEM as a rescue treatment for patients with achalasia who failed HM is feasible, safe, and highly effective. It should be the treatment of choice in managing these challenging cases at centers with a high level of experience with POEM.

Effectiveness of endoclips for the treatment of stigmata of recent hemorrhage in the colon of patients with acute lower gastrointestinal tract bleeding.

AIMS AND METHODS: Coaptive thermo coagulation (CTC) for the treatment of stigmata of recent hemorrhage (SRH) in the colon is risky. We evaluated the safety and effectiveness of endoclips in 13 patients with acute lower gastrointestinal bleeding (GIB). Thirty-day re-bleeding and complication rates were comparable to a historical cohort of 41 patients (group 2) who underwent CTC/IE (injection epinephrine) for the management of acute lower GIB. RESULTS: There was no difference in the 30-day re-bleeding rates in the two groups. In group I, immediate hemostasis was successful in all patients. Three of 13 patients (23.1%) developed re-bleeding. In group II, 41 patients from six prior studies underwent CTC and/or IE for the treatment of HRS where 12 (29.3%) developed re-bleeding. There were no immediate complications. CONCLUSIONS: Endoclip deployment is as effective as CTC and/or IE for treatment of SRH in the colon.

Submucosal injection of 0.4% hydroxypropyl methylcellulose facilitates endoscopic mucosal resection of early gastrointestinal tumors.

BACKGROUND AND AIMS: Submucosal injection of a viscoelastic solution prolongs submucosal lift, thus, facilitating endoscopic mucosal resection. Our objective was to assess the safety and clinical effectiveness of 0.4% hydroxypropyl methylcellulose (HPMC) as a submucosal injectant for endoscopic mucosal resection. PATIENTS AND METHODS: A prospective, open-label, multicenter, phase 2 study was conducted at 2 academic institutions in Brazil. Eligible participants included patients with early gastrointestinal tumors larger than 10 mm. Outcomes evaluated included complete resection rates, volume of HPMC injected, duration of the submucosal cushion as assessed visually, histology of the resected leisons, and complication rates. RESULTS: Over a 12-month period, 36 eligible patients with superficial neoplastic lesions (stomach 14, colon 11, rectum 5, esophagus 3, duodenum 3) were prospectively enrolled in the study. The mean size of the resected specimen was 20.4 mm (10 to 60 mm). The mean volume of 0.4% HPMC injected was 10.7 mL (range 4 to 35 mL). The mean duration of the submucosal fluid cushion was 27 minutes (range 9 to 70 min). Complete resection was successfully completed in 89%. Five patients (14%) developed immediate bleeding requiring endoclip and APC application. Esophageal perforation occurred in 1 patient requiring surgical intervention. There were no local or systemic adverse events related to HPMC use over the follow-up period (mean 2.2 mo). CONCLUSION: HPMC solution (0.4%) provides an effective submucosal fluid cushion and is safe for endoscopic resection of early gastrointestinal neoplastic lesions.

Prospective randomized trial of EUS versus ERCP-guided common bile duct stone removal: an interim report (with video).

BACKGROUND: EUS is being increasingly utilized for the diagnosis of choledocholithiasis and microlithiasis, especially in patients with biliary colic. Simultaneously, there is also a rising interest in the use of EUS for therapeutic interventions. OBJECTIVES: Our goal was to assess the effectiveness of EUS-directed common bile duct (CBD) stone removal to compare its safety and effectiveness with ERCP-directed intervention. DESIGN: Interim results of a prospective, randomized, single-center blinded clinical trial. SETTING: A single tertiary care referral center. PATIENTS: Fifty-two patients with uncomplicated CBD stones were prospectively randomized to CBD cannulation and stone removal under EUS or ERCP guidance. MAIN OUTCOME MEASUREMENTS AND INTERVENTIONS: Primary outcome measure was the rate of successful cannulation of the CBD. Secondary outcome measures included successful removal of stones and overall complication rates. RESULTS: CBD cannulation followed by stone extraction was successful in 23 of 26 patients (88.5%) in the EUS group (I) versus 25 of 26 patients (96.2%) in the ERCP group (II) (95% CI, -27.65%, 9.88%). Overall, there were 3 complications in the EUS group and 4 complications in the ERCP group. LIMITATION: The current study is an interim report from a single center report and performed by a single operator. CONCLUSIONS: Our preliminary analysis indicates that outcomes following EUS-guided CBD stone retrieval are equivalent to those following ERCP. EUS-related adverse events are similar to those following ERCP. ERCP and EUS-guided stone retrieval appears to be equally effective for therapeutic interventions of the bile duct. Additional studies are required to validate these preliminary results and to determine predictors of success of EUS-guided stone removal.

Endoscopic treatment of Roux-en-Y gastric bypass-related gastrocutaneous fistulas using a novel biomaterial.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is amongst the commonest surgical intervention for weight loss in obese patients. Gastrocutaneous fistula, which usually occurs along the vertical staple line of the pouch, is amongst its most alarming complications. Medical management comprised of wound drainage, nutritional support, acid suppression, and antibiotics may be ineffective in as many as a third of patients with this complication. We present outcomes after endoscopic application of SurgiSIS, which is a novel biomaterial for the treatment of this complication. DESIGN: A case series of 25 patients. METHODS: Twenty-five patients who had failed conservative medical management of gastrocutaneous fistula after RYGB underwent endoscopic application of SurgiSIS--an acellular fibrogenic matrix biomaterial to help fistula healing. MAIN OUTCOME MEASURES: Fistula closure as assessed by upper gastrointestinal imaging and endoscopic examination. RESULTS: In patients who had failed medical management lasting 4-25 (median, 7) weeks, closure of the fistulous tract was successful after one application in six patients (30%), two applications in 11 patients (55%), and three applications in three patients (15%). There were no procedure-related complications. CONCLUSIONS: Endoscopic application of SurgiSIS-an acellular fibrogenic matrix--is safe and effective for the treatment of gastrocutaneous fistula after RYGB.

EUS-guided percutaneous endoscopic gastrostomy for enteral feeding tube placement.

BACKGROUND: Patients without adequate abdominal-wall transillumination are at a high risk of developing complications after PEG. OBJECTIVE: We evaluated the feasibility and utility of EUS to guide PEG in patients lacking abdominal-wall transillumination. DESIGN: Single-center case series. SETTING: Tertiary-referral center. PATIENTS: Six patients who lacked adequate abdominal-wall transillumination and 2 patients with a large laparotomy scar deemed to be at high risk of developing complications after PEG. INTERVENTIONS: Patients underwent EUS-guided PEG and deployment of a standard enteral feeding tube. MAIN OUTCOME MEASUREMENTS: Technical success and complication rates. RESULTS: PEG was successful under EUS guidance in 5 of 8 patients. Causes of failure included an inadequate EUS window because of a prior Billroth 1 gastrectomy in one and suspected bowel interposition in 2 patients. There were no complications. LIMITATIONS: A small number of patients, uncontrolled study, and short follow-up period. CONCLUSIONS: This technique may facilitate deployment of PEG in patients who lack adequate abdominal-wall transillumination.

A decision support system to facilitate management of patients with acute gastrointestinal bleeding.

OBJECTIVE: To develop a model to predict the bleeding source and identify the cohort amongst patients with acute gastrointestinal bleeding (GIB) who require urgent intervention, including endoscopy. Patients with acute GIB, an unpredictable event, are most commonly evaluated and managed by non-gastroenterologists. Rapid and consistently reliable risk stratification of patients with acute GIB for urgent endoscopy may potentially improve outcomes amongst such patients by targeting scarce healthcare resources to those who need it the most. DESIGN AND METHODS: Using ICD-9 codes for acute GIB, 189 patients with acute GIB and all available data variables required to develop and test models were identified from a hospital medical records database. Data on 122 patients was utilized for development of the model and on 67 patients utilized to perform comparative analysis of the models. Clinical data such as presenting signs and symptoms, demographic data, presence of co-morbidities, laboratory data and corresponding endoscopic diagnosis and outcomes were collected. Clinical data and endoscopic diagnosis collected for each patient was utilized to retrospectively ascertain optimal management for each patient. Clinical presentations and corresponding treatment was utilized as training examples. Eight mathematical models including artificial neural network (ANN), support vector machine (SVM), k-nearest neighbor, linear discriminant analysis (LDA), shrunken centroid (SC), random forest (RF), logistic regression, and boosting were trained and tested. The performance of these models was compared using standard statistical analysis and ROC curves. RESULTS: Overall the random forest model best predicted the source, need for resuscitation, and disposition with accuracies of approximately 80% or higher (accuracy for endoscopy was greater than 75%). The area under ROC curve for RF was greater than 0.85, indicating excellent performance by the random forest model. CONCLUSION: While most mathematical models are effective as a decision support system for evaluation and management of patients with acute GIB, in our testing, the RF model consistently demonstrated the best performance. Amongst patients presenting with acute GIB, mathematical models may facilitate the identification of the source of GIB, need for intervention and allow optimization of care and healthcare resource allocation; these however require further validation.

Cholesterol Crystal Embolization to the Kidney and to a Duodenal Leiomyoma.

Cholesterol crystal embolism can be spontaneous or iatrogenic, and it can involve any organ of the gastrointestinal tract, presenting with common gastrointestinal symptoms such as bleeding, perforation, obstruction, and inflammation. It is therefore considered the "great masquerader," requiring a high level of suspicion because the condition is associated with increased morbidity and mortality. We present a 69-year-old man who presented with gastrointestinal bleeding and azotemia. He was found to have cholesterol crystal embolization in the kidney and a duodenal leiomyoma, the latter being an uncommon site to embolize.

Laparoscopic deployment of biliary self-expandable metal stent (SEMS) for one-step palliation in 23 patients with advanced pancreatico-biliary tumors--a pilot trial.

BACKGROUND: Exploratory laparoscopy is commonly undertaken in patients with highly suspicious biliary and pancreatic lesions to facilitate diagnosis and staging cancer is present. If an unresectable tumor is identified, a second endoscopic procedure may be required do deploy a self-expandable metal stent (SEMS) for palliation. As endoscopic retrograde cholangio pancreatography (ERCP) may be unsuccessful in up to 20% of patients, we evaluated the feasibility and safety of deployment of self-expandable metal stents at the same time as the initial laparoscopy. PATIENTS AND METHODS: A total of 23 eligible patients (8 male and 15 female) with malignant obstruction of the common bile duct underwent deployment of SEMS at laparoscopy. Primary outcome measure was the successful laparoscopic deployment of stent and secondary outcome measure was complications rates. RESULTS: Indications for stent deployment were unresectable pancreatic cancer in 18, cholangiocarcinoma in two, neuroendocrine tumor in one and ampullary adenocarcinoma in two patients. The median age was 73 years (range 49-93). Twenty-two of 23 stents were deployed successfully: 17 stents were deployed transcystically and five via a choledochotomy. Median times for laparoscopic exploration and SEMS deployment were 165 min (range 105-230) and 20 min (range 10-50), respectively. Pre- and post-procedures median total bilirubin were 9.4 mg/dl (range 5.4-17.5) and 4.0 (range 2.6-7.1). The median size of the pancreatic mass was 3 cm (range 2-5 cm) and that of the common bile duct (CBD) from 9.2 mm (range 7.2-17.4). The mean duration of laparoscopy was 170 min (range 120-230 min) and that for stent deployment 23 min (range 10-50 min). Complications included bleeding, obstruction, and wound infection. Bleeding occurred on day 7 in two patients and on day 30 in one patient; bleeding occurred at the gastrojejunal anastomosis site and was successfully treated with endoscopic hemostasis. A total of three stent obstructions were identified: one each at 60, 90, and 120 days follow-up. All complications were successfully managed endoscopically. There were a total of seven deaths, six as a result of progressive cancer and one of surgical wound infection and ensuing complications. CONCLUSION: This study demonstrates that laparoscopic deployment of self-expandable metal bile duct stents is feasible and safe. This option appears to be a reasonable option in patients with inoperable malignant obstruction of the distal common bile duct.

Rotatable sphincterotome facilitates bile duct cannulation in patients with altered ampullary anatomy.

In patients who have undergone prior Billroth-II (B-II) anastomosis, endoscopic retrograde cholangiopancreatography (ERCP) is challenging due to altered duodenal anatomy, which requires use of customized sphincterotomes. We report the use of a standard rotat-able sphincterotome for successful cannulation in 5 patients with prior B-II gastrojejunostomy and 1 patient with choledochoduodenostomy. In our experience, cannulation and endoscopic intervention were successfully accomplished in all patients without any complications. Although retrospective case series analysis limits the conclusiveness of our findings, we believe that a rotatable sphincterotome can be successfully utilized to cannulate the common bile duct in patients with prior B-II anastomosis, thereby eliminating the need to maintain an inventory of specialized accessories.

Guidewire cannulation reduces risk of post-ERCP pancreatitis and facilitates bile duct cannulation.

OBJECTIVE: To evaluate if using a soft-tipped guidewire to cannulate the common bile duct may ameliorate development of post-ERCP pancreatitis and facilitate cannulation of the CBD. DESIGN AND SETTING: A single-center, blinded, randomized trial of conventional cannulation technique using sphinctertome and contrast injection versus guidewire cannulation technique. METHODS: We prospectively randomized 300 patients to conventional cannulation (group I) or guidewire cannulation (group II) technique. OUTCOME MEASURES: Primary outcome measure was incidence of acute pancreatitis and secondary outcome measures were ease of cannulation of common bile duct (assessed by attempts required for common bile duct cannulation & rates of precut sphincterotomy) and overall complication rates. RESULTS: Guidewire cannulation was associated with significantly lower likelihood of post-ERCP pancreatitis (adjusted OR 0.43, 95% CI 0.21-0.89, P= 0.02). Twenty-five patients (16.6%) in group I and thirteen patients (8.6%) in group II developed acute pancreatitis, P= 0.037. All instances of pancreatitis were mild. There were more women in group II; 41 in group I and 59 in group II, P= 0.028. Otherwise the two groups were comparable for age, age under 35 yr, indication for ERCP, diagnosis, and number of patients with SOD. The number of patients requiring 0-3, 4-6, and 7-10 attempts for successful cannulation of the common bile duct were 87, 48, and 15 in group I and 117, 24, and 9 in group II, respectively, P= 0.001. A total of 33 patients in group I and 13 patients in group II required precut sphincterotomy, P= 0.007. Rates of accidental pancreatic duct cannulation were 21 in group I and 27 in group II, P= 0.34. Rates of overall complication were not significantly different in the two groups. CONCLUSIONS: Guidewire technique for bile duct cannulation lowers likelihood of post-ERCP pancreatitis by facilitating cannulation and reducing need for precut sphincterotomy.