Intravenous Hemin, a potential heme oxygenase-1 activator, does not protect from post-ERCP acute pancreatitis in humans: Results of a randomized multicentric multinational placebo-controlled trial.

OBJECTIVE: Hemin, a heme oxygenase 1 activator has shown efficacy in the prevention and treatment of acute pancreatitis in mouse models. We conducted a randomized controlled trial (RCT) to assess the protective effect of Hemin administration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in patients at risk. METHODS: In this multicenter, multinational, placebo-controlled, double-blind RCT, we assigned patients at risk for PEP to receive a single intravenous dose of Hemin (4 mg/kg) or placebo immediately after ERCP. Patients were considered to be at risk on the basis of validated patient- and/or procedure-related risk factors. Neither rectal NSAIDs nor pancreatic stent insertion were allowed in randomized patients. The primary outcome was the incidence of PEP. Secondary outcomes included lipase elevation, mortality, safety, and length of stay. RESULTS: A total of 282 of the 294 randomized patients had complete follow-up. Groups were similar in terms of clinical, laboratory, and technical risk factors for PEP. PEP occurred in 16 of 142 patients (11.3%) in the Hemin group and in 20 of 140 patients (14.3%) in the placebo group (p = 0.48). Incidence of severe PEP reached 0.7% and 4.3% in the Hemin and placebo groups, respectively (p = 0.07). Significant lipase elevation after ERCP did not differ between groups. Length of hospital stay, mortality and severe adverse events rates were similar between groups. CONCLUSION: We failed to detect large improvements in PEP rate among participants at risk for PEP who received IV hemin immediately after the procedure compared to placebo. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number, NCT01855841).

Endoscopic Treatment of Large Bile Duct Stones: A Systematic Review and Network Meta-Analysis.

BACKGROUND & AIMS: Several endoscopic methods have been proposed for the treatment of large biliary stones. We assessed the comparative efficacy of these treatments through a network meta-analysis. METHODS: Nineteen randomized controlled trials (2752 patients) comparing different treatments for management of large bile stones (>10 mm) (endoscopic sphincterotomy, balloon sphincteroplasty, sphincterotomy followed by endoscopic papillary large balloon dilation [S+EPLBD], mechanical lithotripsy, single-operator cholangioscopy [SOC]) with each other were identified. Study outcomes were the success rate of stone removal and the incidence of adverse events. We performed pairwise and network meta-analysis for all treatments, and used Grading of Recommendations, Assessment, Development, and Evaluation criteria to appraise the quality of evidence. RESULTS: All treatments except mechanical lithotripsy significantly outperformed sphincterotomy in terms of stone removal rate (risk ratio [RR], 1.03-1.29). SOC was superior to other adjunctive interventions (vs balloon sphincteroplasty [RR, 1.24; 95% CIs, 1.07-1.45], vs S+EPLBD [RR, 1.23; range, 1.06-1.42] and vs mechanical lithotripsy [RR, 1.34; range, 1.14-1.58]). Cholangioscopy ranked the highest in increasing the success rate of stone removal (surface under the cumulative ranking [SUCRA] score, 0.99) followed by S+EPLBD (SUCRA score, 0.68). SOC and S+EPLBD outperformed the other modalities when only studies reporting on stones greater than 15 mm were taken into consideration (SUCRA scores, 0.97 and 0.71, respectively). None of the assessed interventions was significantly different in terms of adverse event rate compared with endoscopic sphincterotomy or with other treatments. Post-ERCP pancreatitis and bleeding were the most frequent adverse events. CONCLUSIONS: Among patients with large bile stones, cholangioscopy represents the most effective method, in particular in patients with larger (>15 mm) stones, whereas S+EPLBD could represent a less expensive and more widely available alternative.

Magnet and wire remodeling for the treatment of candy cane syndrome: first case series of a new approach (with video).

BACKGROUND AND AIMS: Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. Preferential passage of food to the blind loop induces early satiety, pain, and regurgitation. An endoscopic device that combines 2 magnets and a self-retractable wire was designed to perform progressive septotomy with marsupialization. We evaluated the clinical safety and efficacy of this treatment in CCS. METHODS: Consecutive patients presenting with symptoms associated with CCS after gastrectomy or Roux-en-Y gastric bypass were treated with the MAGUS (Magnetic Gastrointestinal Universal Septotome) system. Weight, dysphagia, pain scores, 12-item Short Form Survey quality of life physical and mental scores, GERD Health-Related Quality of Life, and Eckardt score were measured at baseline and 1 and 3 months postprocedure. Satisfaction with therapy and AEs were monitored during follow-up. RESULTS: Fourteen consecutive patients with CCS were enrolled in the study. Thirteen MAGUS systems migrated within 28 days after achieving uneventful complete septotomy. In 1 patient the magnet had to be collected from the right-sided colon after 1 month. Treatment was completed in a single endoscopy session. Dysphagia score (2 [1-3] vs 1 [1-1], P = .02), pain score (7 [6-8] vs 1 [0-1], P = .002), Eckardt score (5 [3-8] vs 1 [0-2], P = .002), GERD Health-Related Quality of Life score (37 [29-45] vs 8 [6-23], P = .002), and quality of life physical and mental scores were all significantly improved at 3 months. No device or procedure-related serious AEs were observed. One patient died during follow-up from evolution of oncologic disease. CONCLUSIONS: Endoluminal septotomy using a retractable wire and magnet system in CCS is feasible and safe, with rapid improvement of symptoms. (Clinical trial registration number: NCT04480216.).

Endoscopic internal drainage of complex bilomas and biliary leaks by transmural or transpapillary/transfistulary access.

BACKGROUND AND AIMS: Bilomas most frequently result from postoperative bile leaks. The endoscopic conventional treatment is sphincterotomy ± stent placement. In complex cases, such as altered anatomy or failure of conventional treatment, transpapillary/transfistulary (TP/TF) drainage or EUS-guided transmural drainage (EUS-TD) may obviate additional biliary surgery. This study reports our experience with treating biloma secondary to refractory biliary leak with TP/TF drainage or EUS-TD and evaluates the safety and outcomes associated with this approach. METHODS: This observational study focused on consecutive patients managed for biliary leakage (diagnosis based on imaging and/or bile outflow from a surgical drain) at a tertiary care hospital (2007-2017). TP/TF drainage was performed by double-pigtail stent(s) placement to drain the biloma through the leak during ERCP. For EUS-TD, plastic stent(s) were placed under EUS control. Primary outcomes were a composite of clinical success (patient free of sepsis after percutaneous drain removal and, in patients with benign disease, removal of all endoscopically placed stents, without need for reintervention) and biloma regression (<3 cm) at last follow-up. RESULTS: Thirty patients (men, 57%; median age, 55 years) were included. Most biliary leaks resulted from cholecystectomy (27%) and hepatectomy (50%). Initial EUS-TD and TP/TF drainage were performed in 14 (47%) and 16 (53%) patients, respectively. At last follow-up (median, 33.2 months), clinical success and primary outcome were achieved in 70.4% of patients (EUS-TD, 75%; TP/TF, 67%). Additional surgery was necessary in 1 patient. Rate of serious adverse events was 23% (7/30), of which 13% (4/30) were procedure related. There were 4 deaths during the course of treatment, 2 of which were related to endoscopic interventions (hemorrhage and fibrillation). CONCLUSIONS: TP/TF drainage or EUS-TD is technically feasible with high clinical success and may avoid the need for additional surgery in complex cases or in patients with altered anatomy.

Magnets and a self-retractable wire for endoscopic septotomies: from concept to first-in-human use.

BACKGROUND: A medical device that allows simple and safe performance of an endoscopic septotomy could have several applications in the gastrointestinal (GI) tract. We have developed such a device by combining two magnets and a self-retractable wire to perform a progressive septotomy by compression of the tissues. We describe here the concept, preclinical studies, and first clinical use of the device for the treatment of symptomatic epiphrenic esophageal diverticulum (EED). METHODS: The MAGUS (MAgnetic Gastrointestinal Universal Septotome) device was designed based on previous knowledge of compression anastomosis and currently unmet needs. After initial design, the feasibility of the technique was tested on artificial septa in pigs. A clinical trial was then initiated to assess the feasibility and safety of the technique. RESULTS: Animal studies showed that the MAGUS can perform a complete septotomy at various levels of the GI tract. In two patients with a symptomatic EED, uneventful complete septotomy was observed within 28 and 39 days after the endoscopic procedure. CONCLUSIONS: This new system provides a way of performing endoluminal septotomy in a single procedure. It appears to be effective and safe for managing symptomatic EED. Further clinical applications where this type of remodeling of the GI tract could be beneficial are under investigation.

Indwelling double-pigtail plastic stents for treating disconnected pancreatic duct syndrome-associated peripancreatic fluid collections: long-term safety and efficacy.

BACKGROUND: Long-term transmural double-pigtail stent (DPS) placement is recommended for patients with disconnected pancreatic duct syndrome (DPDS) and peripancreatic fluid collections (peri-PFCs). The long-term safety and efficacy of indwelling DPSs were evaluated. METHODS: Medical files of patients treated with DPS for DPDS-associated peri-PFC and with a follow-up ≥ 48 months were reviewed. Early ( < 30 days) and late complications of DPS placement were evaluated and the primary endpoint, i. e., incidence of late complications per 100 patient-years of follow-up, was calculated. Short- and long-term success rates of endoscopic treatment and rate of peri-PFC recurrence were among secondary endpoints. RESULTS: From 2002 to 2014 we identified 116 patients, with mean (SD) follow-up of 80.6 (34.4) months. Among early complications (n = 20), 6 occurred peri-interventionally. Late complications (n = 17) were mainly pain due to DPS-induced ulcer or erosion (n = 10) and 14 of these were treated conservatively or by stent removal; 2 gastro-pancreatico-colo-cutaneous fistulas and 1 persisting bleed required surgical intervention. No DPS-related deaths were recorded. The incidence rate (95 %CI) of late complications was 2.18 (1.27-3.49) per 100 patient-years of follow-up. Short- and long-term success rates (with 95 %CI) of endoscopic treatment were 97.4 % (94.5 %-100 %) and 94 % (89.6 %-98.3 %), respectively. The peri-PFC recurrence rate was 28 % (20.1 %-35.9 %), and 92.3 % of these occurred within the first 2 years. Stent migration, chronic pancreatitis, and length of stent (> 6 cm) were independently associated with higher rates of peri-PFC recurrence. CONCLUSIONS: Long-term transmural drainage with DPS is a safe and effective treatment for DPDS-associated peri-PFCs. However, about one quarter of peri-PFCs will recur.

Esophageal stenting for benign and malignant disease: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021.

MALIGNANT DISEASE: 1: ESGE recommends placement of partially or fully covered self-expandable metal stents (SEMSs) for palliation of malignant dysphagia over laser therapy, photodynamic therapy, and esophageal bypass.Strong recommendation, high quality evidence. 2 : ESGE recommends brachytherapy as a valid alternative, alone or in addition to stenting, in esophageal cancer patients with malignant dysphagia and expected longer life expectancy.Strong recommendation, high quality evidence. 3: ESGE recommends esophageal SEMS placement for sealing malignant tracheoesophageal or bronchoesophageal fistulas. Strong recommendation, low quality evidence. 4 : ESGE does not recommend SEMS placement as a bridge to surgery or before preoperative chemoradiotherapy because it is associated with a high incidence of adverse events. Other options such as feeding tube placement are preferable. Strong recommendation, low quality evidence. BENIGN DISEASE: 5: ESGE recommends against the use of SEMSs as first-line therapy for the management of benign esophageal strictures because of the potential for adverse events, the availability of alternative therapies, and their cost. Strong recommendation, low quality evidence. 6: ESGE suggests consideration of temporary placement of self-expandable stents for refractory benign esophageal strictures. Weak recommendation, moderate quality evidence. 7: ESGE suggests that fully covered SEMSs be preferred over partially covered SEMSs for the treatment of refractory benign esophageal strictures because of their very low risk of embedment and ease of removability. Weak recommendation, low quality evidence. 8: ESGE recommends the stent-in-stent technique to remove partially covered SEMSs that are embedded in the esophageal wall. Strong recommendation, low quality evidence. 9: ESGE recommends that temporary stent placement can be considered for the treatment of leaks, fistulas, and perforations. No specific type of stent can be recommended, and the duration of stenting should be individualized. Strong recommendation, low quality of evidence. 10 : ESGE recommends considering placement of a fully covered large-diameter SEMS for the treatment of esophageal variceal bleeding refractory to medical, endoscopic, and/or radiological therapy, or as initial therapy for patients with massive bleeding. Strong recommendation, moderate quality evidence.

Biliary cast syndrome after liver transplantation: A cholangiographic evolution study.

BACKGROUND AND AIM: The aim of this study is to describe the cholangiographic features and endoscopic management of biliary cast syndrome (BCS), a rare specific ischemic cholangiopathy following liver transplantation. METHODS: Patients with biliary complications were identified from prospectively collected database records of patients who underwent liver transplantation at the Erasme Hospital from January 2005 to December 2014. After excluding patients with hepatico-jejunostomy or no suspicion of stricture, cholangiograms obtained during endoscopic retrograde cholangiopancreatography (ERCP) and magnetic resonance imaging were systematically reviewed. Biliary complications were categorized as anastomotic (AS) and non-AS strictures, and patients with BCS were identified. Clinical, radiological, and endoscopic data were reviewed. RESULTS: Out of 311 liver transplantations, 14 cases were identified with BCS (4.5%) and treated with ERCP. Intraductal hyperintense signal on T1-weighted magnetic resonance and a "duct-in-a-duct" image were the most frequent features of BCS on magnetic resonance imaging. On initial ERCP, 57% of patients had no stricture. Complete cast extraction was achieved in 12/14, and one of these had cast recurrence. On follow-up, 85% of the patients developed biliary strictures that were treated with multiple plastic stents reaching 60% complete stricture resolution, but 40% of them had recurrence. After a median follow-up of 58 months, BCS patients had lower overall and graft survival (42.9% and 42.9%) compared with non-AS (68.8% and 56.3%) and AS (83.3% and 80.6%), respectively. CONCLUSIONS: Particular magnetic resonance-cholangiographic and ERCP-cholangiographic features of BCS have been identified. Outcomes for BCS are characterized by high complete cast extraction rates, high incidence of secondary strictures, and poorer prognosis.

Fully covered self-expanding metal stents for benign biliary stricture after orthotopic liver transplant: 5-year outcomes.

BACKGROUND AND AIMS: Minimally invasive treatments of anastomotic benign biliary stricture (BBS) after orthotopic liver transplantation (OLT) include endoscopic placement of multiple plastic stents or fully covered self-expandable metal stents (FCSEMSs). No multiyear efficacy data are available on FCSEMS treatment after OLT. METHODS: We prospectively studied long-term efficacy and safety of FCSEMS treatment in adults aged ≥18 years with past OLT, cholangiographically confirmed BBS, and an indication for ERCP with stent placement. Stent removal was planned after 4 to 6 months, with subsequent follow-up until 5 years or stricture recurrence. Long-term outcomes were freedom from stricture recurrence, freedom from recurrent stent placement, and stent-related serious adverse events (SAEs). RESULTS: In 41 patients, long-term follow-up began after FCSEMS removal (n = 33) or observation of complete distal migration (CDM) (n = 8). On an intention-to-treat basis, the 5-year probability of remaining stent-free after FCSEMS removal or observation of CDM was 48.9% (95% confidence interval [CI], 33.2%-64.7%) among all patients and 60.9% (95% CI, 43.6%-78.2%) among 31 patients with over 4 months of FCSEMS indwell time. In 28 patients with stricture resolution at FCSEMS removal or observed CDM (median, 5.0 months indwell time), the 5-year probability of no stricture recurrence was 72.6% (95% CI, 55.3%-90%). Sixteen patients (39%) had at least 1 related SAE, most commonly cholangitis (n = 10). CONCLUSIONS: By 5 years after temporary FCSEMS treatment of post-OLT BBS, approximately half of all patients remained stent-free on an intention-to-treat basis. Stent-related SAEs (especially cholangitis) were common. FCSEMS placement is a viable long-term treatment option for patients with post-OLT BBS. (Clinical trial registration number: NCT01014390.).

Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017.

ESGE recommends against routine preoperative biliary drainage in patients with malignant extrahepatic biliary obstruction; preoperative biliary drainage should be reserved for patients with cholangitis, severe symptomatic jaundice (e. g., intense pruritus), or delayed surgery, or for before neoadjuvant chemotherapy in jaundiced patients. Strong recommendation, moderate quality evidence. ESGE recommends the endoscopic placement of a 10-mm diameter self-expandable metal stent (SEMS) for preoperative biliary drainage of malignant extrahepatic biliary obstruction. Strong recommendation, moderate quality evidence.ESGE recommends SEMS insertion for palliative drainage of of extrahepatic malignant biliary obstruction. Strong recommendation, high quality evidence. ESGE recommends against the insertion of uncovered SEMS for the drainage of extrahepatic biliary obstruction of unconfirmed etiology. Strong recommendation, low quality evidence. ESGE suggests against routine preoperative biliary drainage in patients with malignant hilar obstruction. Weak recommendation, low quality evidence.ESGE recommends uncovered SEMSs for palliative drainage of malignant hilar obstruction. Strong recommendation, moderate quality evidence.ESGE recommends temporary insertion of multiple plastic stents or of a fully covered SEMS for treatment of benign biliary strictures. Strong recommendation, moderate quality evidence.ESGE recommends endoscopic placement of plastic stent(s) to treat bile duct leaks that are not due to transection of the common bile duct or common hepatic duct. Strong recommendation, moderate quality evidence.

Endoscopic Full-Thickness Resection of a Colonic Lateral Spreading Tumor.

The Full-Thickness Resection Device (FTRD; Ovesco Endoscopy, Tübingen, Germany) combines endoscopic full-thickness resection (EFTR) of gastrointestinal lesions with closure and cutting of the tissue in one integrated procedure. It provides en-bloc resection with an integral wall specimen for histopathological evaluation. This resection technique is partially filling of the gaps between the current procedures of choice in endoscopy (endoscopic mucosal resection and endoscopic submucosal dissection) and surgery. We present the case of an EFTR procedure performed for a periappendicular lateral spreading tumor.

Successful management of benign biliary strictures with fully covered self-expanding metal stents.

BACKGROUND & AIMS: Fully covered self-expanding metal stents (FCSEMS) are gaining acceptance for the treatment of benign biliary strictures. We performed a large prospective multinational study to study the ability to remove these stents after extended indwell and the frequency and durability of stricture resolution. METHODS: In a nonrandomized study at 13 centers in 11 countries, 187 patients with benign biliary strictures received FCSEMS. Removal was scheduled at 10-12 months for patients with chronic pancreatitis or cholecystectomy and at 4-6 months for patients who received liver transplants. The primary outcome measure was removal success, defined as either scheduled endoscopic removal of the stent with no removal-related serious adverse events or spontaneous stent passage without the need for immediate restenting. RESULTS: Endoscopic removal of FCSEMS was not performed for 10 patients because of death (from unrelated causes), withdrawal of consent, or switch to palliative treatment. For the remaining 177 patients, removal success was accomplished in 74.6% (95% confidence interval [CI], 67.5%-80.8%). Removal success was more frequent in the chronic pancreatitis group (80.5%) than in the liver transplantation (63.4%) or cholecystectomy (61.1%) groups (P = .017). FCSEMS were removed by endoscopy from all patients in whom this procedure was attempted. Stricture resolution without restenting upon FCSEMS removal occurred in 76.3% of patients (95% CI, 69.3%-82.3%). The rate of resolution was lower in patients with FCSEMS migration (odds ratio, 0.22; 95% CI, 0.11-0.46). Over a median follow-up period of 20.3 months (interquartile range, 12.9-24.3 mo), the rate of stricture recurrence was 14.8% (95% CI, 8.2%-20.9%). Stent- or removal-related serious adverse events, most often cholangitis, occurred in 27.3% of patients. There was no stent- or removal-related mortality. CONCLUSIONS: In a large prospective multinational study, removal success of FCSEMS after extended indwell and stricture resolution were achieved for approximately 75% of patients. ClincialTrials.gov number, NCT01014390.

Endoscopic treatment for Zenker's diverticulum: long-term results (with video).

BACKGROUND: Diverticulotomy is a standard treatment for Zenker's diverticulum (ZD). This technique was adapted to flexible endoscopy. OBJECTIVE: We report our long-term results of ZD treatment by using flexible endoscopy assisted by a soft diverticuloscope. DESIGN: Follow-up study. SETTING: Academic hospital. Tertiary-care referral center. PATIENTS: A total of 150 patients with ZD were treated with the same technique from July 2002 to June 2011. INTERVENTION: The procedure was performed by using a soft diverticuloscope to expose the septum, which was then cut with a needle-knife, and the procedure was completed by use of endoclip placement at the bottom of the section. MAIN OUTCOME MEASUREMENTS: Symptoms were compared before and after the procedure, 1 month later, and at the end of follow-up. RESULTS: The median size of the ZD was 3 cm (range 1-8 cm). The endoscopic incision was performed in one session (range 1-3 sessions). Clinical success at 1 month was 90.3%. Four adverse events (2.2%) occurred and were managed conservatively. Symptom evaluation at 1 month and at the end of follow-up was obtained in 103 and 134 patients, respectively. The dysphagia score dropped from 1.88 to 0.29 (P < .01) and 0.34 (P < .05) at 1 month and at the end of follow-up, respectively (median 43 months, range 13-121 months). Regurgitations and chronic cough dropped from 73% and 27% to 11% and 2% at the end of follow-up, respectively. Symptom recurrence occurred in 31 patients (23.1%); among them 23 had a second treatment, and only 5 required a third one. LIMITATIONS: Retrospective study, single center. CONCLUSION: Endoscopic incision of ZD by using a soft diverticuloscope and completed by endoclips is safe and efficient at short term and long term.

Portal cavernography during endoscopic retrograde cholangiopancreatography: from bilhemia to hemobilia.

Portobiliary fistulas are rare but may lead to life-threatening complications. Biliary plastic stent-induced portobiliary fistulas during endoscopic retrograde cholangiopancreatography have been described. Herein, we present a case of portal cavernography and recurrent hemobilia after endoscopic retrograde cholangiopancreatography in which a portobiliary fistula was detected in a patient with portal biliopathy. This likely indicates a change in clinical presentation (from bilhemia to hemobilia) after biliary drainage that was successfully treated by placement of a fully covered, self-expandable metallic stent.

Guidewire-assisted placement of water-perfused esophageal high-resolution manometry probe when gastric insertion fails: A single-center experience.

BACKGROUND: Blind positioning of a high-resolution manometry (HRM) probe across the esophagogastric junction (EGJ) is not always possible. We report our experience using guidewire-assisted water-perfused HRM probe insertion when the EGJ could not be traversed. METHODS: Retrospective study analyzing the failure rate of EGJ insertion during HRM, and reporting a series of guidewire-assisted procedures. KEY RESULTS: Among 2727 HRM procedures, the failure rate for traversing the EGJ was 2.7% (73 patients). The technique of guidewire-assisted placement of the HRM probe was used in 25 patients; it was well-tolerated and successful in all patients. No motility disorder was found in 6 patients. In four patients with previously diagnosed achalasia, achalasia subtype changed to type III in one patient. While a suspected motility disorder at barium esophagram and/or initial imperfect HRM tracing was confirmed in 10 patients, a new motility disorder was diagnosed in five patients using guidewire-assisted placement of the HRM probe. CONCLUSIONS AND INFERENCES: In cases of inability to traverse the EGJ, insertion of a water-perfused HRM probe using an endoscopically-placed nasogastric guidewire allows successful EGJ and esophageal peristalsis assessment. Although motility disorders are often suspected using alternative diagnostic modalities, guidewire-assisted placement of HRM may be helpful for revealing them in patients where alternative diagnostic modalities are either unavailable or inconclusive.

A Gastrobronchial Fistula Secondary to Endoscopic Internal Drainage of a Post-Sleeve Gastrectomy Fluid Collection.

A 44-year-old woman underwent sleeve gastrectomy, which was complicated by a leak. She was treated with two sessions of endoscopic internal drainage using plastic double-pigtail stents. Her clinical evolution was favorable, but four months after the initial stent placement, she became symptomatic, and a gastrobronchial fistula with the proximal end of the stents invading the diaphragm was diagnosed. She was treated with antibiotics, plastic stents were removed, and a partially covered metallic esophageal stent was placed. Eleven weeks later, the esophageal stent was removed with no evidence of fistula. Inappropriate stent size, position, stenting duration, and persistence of low-grade inflammation could explain the patient's symptoms and provide a mechanism for gradual muscle rupture and fistula formation. Although endoscopic internal drainage is usually safe and effective for the management of post-laparoscopic sleeve gastrectomy leaks, close clinical and radiological follow-up is mandatory.

Pneumatic dilation for the treatment of persistent post-laparoscopic fundoplication dysphagia: long-term efficacy and safety.

BACKGROUND: Post-laparoscopic fundoplication (LF) dysphagia occurs in 5%-17% of patients and optimal management remains a topic of expert discussion. We assessed the efficacy and safety of pneumatic dilation (PD) in patients with persistent post-lLF dysphagia. METHODS: Medical files of patients treated with PD for persistent post-fundoplication-associated dysphagia were reviewed. The primary outcome was long-term clinical success. Secondary endpoints were initial clinical success, dysphagia recurrence rate, and PD-related complication incidence. RESULTS: Overall, 46 patients (74% women, 57.9±11.9 years) underwent 74 PD (mean: 1.6±0.8). A 30 mm, 35 mm, and 40 mm balloon was used in 45.9%, 43.2%, and 10.8%, respectively, of dilations. Among 45 patients with available follow-up, the overall long-term success rate of PD was 31/45 (68.9% [55.4-82.4]). Initial clinical success was 36/45 (80% [68.3-91.7]). Dysphagia recurred in 9 patients (25%; 95%CI 10.9-39.1) and 4 of these were effectively treated with a new dilation. Among 14 non-responders to PD, 11 underwent surgery. Four complications (2 perforations, 1 muscularis dilaceration, and 1 peri-procedural bleeding) occurred in 4 patients (incidence: 5.4% [95%CI; 0.3-10.6]) and were treated with partially covered self-expandable esophageal stents andhemostatic clips. CONCLUSIONS: Pneumatic balloon dilation for post-fundoplication-associated symptoms is associated with a satisfactory long-term success rate and acceptable safety profile.

Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome.

BACKGROUND: Bariatric surgery is associated with specific complications and mortality. Transoral gastroplasty (TOGA) is a transoral restrictive bariatric procedure that might offer the benefits of surgery with a reduced complication rate. OBJECTIVE: To evaluate the safety and efficacy of TOGA at 12-month follow-up. DESIGN: Prospective, multicenter, single-arm trial. SETTING: Two tertiary-care referral medical centers. PATIENTS: This study involved 67 patients (average age 41.0 years, 47 women, baseline body mass index [BMI] 41.5 kg/m(2); 20 patients with BMI <40). INTERVENTION: The TOGA procedures were performed by using 2 stapling devices that were used to create a small, restrictive pouch along the lesser gastric curvature. The pouch is designed to give the patient a sustained feeling of satiety after small meals. MAIN OUTCOME MEASUREMENTS: Excess weight loss, excess BMI loss, safety, and improvements in quality of life, obesity-related comorbidities, and medication use. RESULTS: Fifty-three patients were available at the 12-month follow-up. Excess BMI loss was 33.9%, 42.6%, and 44.8% at 3, 6, and 12 months, respectively. At 12 months, excess BMI loss was 52.2% for patients with a baseline BMI of <40.0 and 41.3% for patients with a baseline BMI of ≥ 40.0 (P < .05). At 12 months, hemoglobin A(1c) levels decreased from 7.0% at baseline to 5.7% (P = .01); triglyceride levels decreased from 142.9 mg/dL to 98 mg/dL (P < .0001); high-density lipoprotein levels increased from 47.0 mg/dL to 57.5 mg/dL (P < .0001). Two complications occurred: a case of respiratory insufficiency and an asymptomatic pneumoperitoneum treated conservatively. LIMITATIONS: Small number of patients. Short-term follow-up. Twenty-one percent of patients were not available for the 12-month follow-up. CONCLUSION: The TOGA procedure allowed a substantial weight loss 1 year after the operation without severe complications. A long-term evaluation is needed before definitive conclusions can be drawn.