Chinese expert consensus on interventional diagnosis and management of acquired digestive-respiratory tract fistulas (second edition).

Acquired digestive-respiratory tract fistulas occur with abnormal communication between the respiratory tract and digestive tract caused by a variety of benign or malignant diseases, leading to the alimentary canal contents in the respiratory tract. Although various departments have been actively exploring advanced fistula closure techniques, including surgical methods and multimodal therapy, some of which have gotten good clinical effects, there are few large-scale evidence-based medical data to guide clinical diagnosis and treatment. The guidelines update the etiology, classification, pathogenesis, diagnosis, and management of acquired digestive-respiratory tract fistulas. It has been proved that the implantation of the respiratory and digestive stent is the most important and best treatment for acquired digestive-respiratory tract fistulas. The guidelines conduct an in-depth review of the current evidence and introduce in detail the selection of stents, implantation methods, postoperative management and efficacy evaluation.

Regenerative medicine for digestive fistulae therapy: Benefits, challenges and promises of stem/stromal cells and emergent perspectives via their extracellular vesicles.

Despite current management strategies, digestive fistulae remain extremely debilitating complications associated with significant morbidity and mortality, generating a need to develop innovative therapies in these indications. A number of clinical trials and experimental studies have thus investigated the potential of stem/stromal cells (SCs) or SC-derived extracellular vesicles (EVs) administration for post-surgical and Crohn's-associated fistulae. This review summarizes the physiopathology and current standards-of-care for digestive fistulae, along with relevant evidence from animal and clinical studies regarding SC or EV treatment for post-surgical digestive fistulae. Additionally, existing preclinical models of fistulizing Crohn's disease and results of SC therapy trials in this indication will be presented. The optimal formulation and administration protocol of SC therapy products for gastrointestinal fistula treatment and the challenges for a widespread use of darvadstrocel (Alofisel) in clinical practice will be discussed. Finally, the potential advantages of EV therapy and the obstacles towards their clinical translation will be introduced.

Endoscopic management of inflammatory bowel disease-associated complications.

PURPOSE OF REVIEW: The main complications of inflammatory bowel disease (IBD) are strictures, fistulas, abscesses, and colitis-associated neoplasia. In addition to diagnosis, disease monitoring, and surveillance, endoscopy plays an important role in the management of those complications. This review is to provide up-to-date information in endoscopic treatment modalities for those complications. RECENT FINDINGS: The endoscopic therapy of IBD complication has evolved from balloon dilation of strictures to endoscopic stricturotomy, strictureplasty, stenting, fistulotomy, sinusotomy, and neoplasia ablation. These endoscopic approaches have provided minimally invasive treatment for those complications. SUMMARY: The advances in interventional IBD may be credited to our better understanding of the disease process and nature of targeted lesion, and execution of updated principles and techniques of endoscopy.

Clinical parameters and outcomes of necrotizing soft tissue infections secondary to gastrointestinal fistulas.

BACKGROUND: Necrotizing soft tissue infections (NSTIs) is severe surgical infections which can occur following trauma or abdominal surgery. NSTIs secondary to gastrointestinal (GI) fistula is a rare but severe complication. METHODS: A retrospective cohort study was performed on all subjects presenting with GI fistulas associated NSTIs were included. Clinical characteristics, microbiological profile, operations performed, and outcomes of patients were analyzed. RESULTS: Between 2014 and 2017, 39 patients were finally enrolled. The mean age were 46.9 years and male were the dominant. For the etiology of fistula, 25 (64.1%) of the patients was due to trauma. Overall, in-hospital death occurred in 15 (38.5%) patients. Microbiologic findings were obtained from 31 patients and Klebsiella pneumoniae was the most common species (41.0%). Eight patients were treated with an open abdomen; negative pressure wound therapy was used in 33 patients and only 2 patients received hyperbaric oxygen therapy. Younger age and delayed abdominal wall reconstruction repair were more common in trauma than in non-trauma. Non-survivors had higher APACHE II score, less source control< 48 h and lower platelet count on admission than survivors. Multiple organ dysfunction syndrome, multidrug-resistant organisms and source control failure were the main cause of in-hospital mortality. CONCLUSIONS: Trauma is the main cause of GI fistulas associated NSTIs. Sepsis continues to be the most important factor related to mortality. Our data may assist providing enlightenment for quality improvement in these special populations.

Endoluminal Vacuum Therapy: How I Do It.

Perforations and leaks of the gastrointestinal tract are difficult to manage and are associated with high morbidity and mortality. Recently, endoscopic approaches have been applied with varying degrees of success. Most recently, the use of endoluminal vacuum therapy has been used with high success rates in decreasing both morbidity and mortality. Under an IRB-approved prospective registry that we started in July 2013, we have been using endoluminal vacuum therapy to treat a variety of leaks throughout the GI tract. The procedure uses an endosponge connected to a nasogastric tube that is endoscopically guided into a fistula cavity in order to facilitate healing, obtain source control, and aid in reperfusion of the adjacent tissue with debridement. Endoluminal vacuum therapy has been used on all patients in the registry. Overall success rate for healing the leak or fistula is 95% in the esophagus, 83% in the stomach, 100% in the small bowel, and 60% of colorectal cases. The purpose of this report is to review the history of endoluminal wound vacuum therapy, identify appropriate patient selection criteria, and highlight "pearls" of the procedure. This article is written in the context of our own clinical experience, with a primary focus on a "How I Do It" technical description.

Endoscopic plombage with polyglycolic acid sheets and fibrin glue for gastrointestinal fistulas.

BACKGROUND AND STUDY AIMS: Gastrointestinal (GI) fistulas arise as adverse events of GI surgery and endoscopic treatment as well as secondary to underlying diseases, such as ulceration and pancreatitis. Until a decade ago, they were mainly treated surgically or conservatively. Bioabsorbable polyglycolic acid (PGA) sheets and fibrin glue, which are commonly used in surgical procedures, have also recently been used in endoscopic procedures for the closure of GI defects. However, there have only been few case reports about successful experiences with this approach. There have not been any case-series studies investigating the strengths and weaknesses of such PGA sheet-based treatment. In this study, we evaluated the clinical effectiveness of using PGA sheets to close GI fistulas. PATIENTS AND METHODS: Cases in which patients underwent endoscopic filling with PGA sheets and fibrin glue for GI fistulas at Kobe University Hospital between January 2013 and April 2018 were retrospectively reviewed. RESULTS: A total of 10 cases were enrolled. They included fistulas due to leakage after GI surgery, aortoesophageal/bronchoesophageal fistulas caused by chemoradiotherapy, or severe acute pancreatitis. The fistulas were successfully closed in 7 cases (70%). The unsuccessful cases involved a fistula due to leakage after surgical esophagectomy and bronchoesophageal fistulas due to chemoradiotherapy or severe acute pancreatitis. Unsuccessful treatment was related to fistula epithelization. CONCLUSION: Endoscopic plombage with PGA sheets and fibrin glue could be a promising therapeutic option for GI fistulas.

Over-the-scope clip system: A review of 1517 cases over 9 years.

Rescue therapy for gastrointestinal (GI) refractory bleeding, perforation, and fistula has traditionally required surgical interventions owing to the limited performance of conventional endoscopic instruments and techniques. An innovative clipping system, the over-the-scope clip (OTSC), may play an important role in rescue therapy. This innovative device is proposed as the final option in endoscopic treatment. The device presents several advantages including having a powerful sewing force for closure of GI defects using a simple mechanism and also having an innovative feature, whereby a large defect and fistula can be sealed using accessory forceps. Consequently, it is able to provide outstanding clinical effects for rescue therapy. This review clarifies the current status and limitations of OTSC according to different indications of GI refractory disease, including refractory bleeding, perforation, fistula, and anastomotic dehiscence. An extensive literature search identified studies reported 10 or more cases in which the OTSC system was applied. A total of 1517 cases described in 30 articles between 2010 and 2018 were retrieved. The clinical success rates and complications were calculated overall and for each indication. The average clinical success rate was 78% (n = 1517) overall, 85% for bleeding (n = 559), 85% (n = 351) for perforation, 52% (n = 388) for fistula, 66% (n = 97) for anastomotic dehiscence, and 95% (n = 122) for other conditions, respectively. The overall and severe OTSC-associated complications were 1.7% (n = 23) and 0.59% (n = 9), respectively. This review concludes that the OTSC system may serve as a safe and productive device for GI refractory diseases, albeit with limited success for fistula.

[Efficacy of continuous irrigation combined with closed thoracic drainage for esophagojejunal anastomotic fistula complicated with mediastinal, thoracic and abdominal infections].

OBJECTIVE: To investigate the clinical efficacy of continuous irrigation combined with closed thoracic drainage for esophagojejunal anastomotic fistula (EJAF) complicated with mediastinal, thoracic and abdominal infection after total gastrectomy. METHODS: Clinical data of 22 EJAF patients complicated with mediastinal, thoracic and abdominal infection after radical gastrectomy at Department of General Surgery of the 901th Hospital of PLA from June 2012 to May 2018 were retrospectively analyzed. Case inclusion criteria:(1) gastric adenocarcinoma confirmed by preoperative endoscopic pathology undergoing radical total gastrectomy without severe organ dysfunction;(2)EJAF complicated with mediastinal, thoracic and abdominal infections diagnosed by postoperative radiography, the presence of pleural effusion confirmed by CT and ultrasound. Among them, 10 cases were treated with simple thoracic closed drainage (single drainage group); 12 cases received same closed thoracic drainage, and a rubber catheter was placed next to the closed thoracic drainage tube in the same sinus. A 0.9% sodium chloride solution was applied in continuous drip irrigation with drip velocity at 50 to 100 ml/h(continuous flushing plus drainage group). Infection indicators, anastomotic fistula healing time and related clinical indicators were compared between the two groups. RESULTS: In the simple drainage group, 5 cases were males, age was (61.9±10.7) years old, 4 cases received laparoscopic surgery, 6 cases received open surgery, 6 cases were EJAF grade III, 4 cases were EJAF IV. In continuous flushing and drainage group, 6 cases were males, age was (61.7±11.0) years old, 7 cases received laparoscopic surgery, 5 cases received open surgery, 6 cases were EJAF grade III, and 6 cases were EJAF grade IV. Baseline data including gender, age, underlying diseases, preoperative hematological examination indexes, surgical methods, tumor TNM stage and EJAF grade were not significantly different between the two groups (all P>0.05). When postoperative EJAF was complicated with mediastinal, thoracic and abdominal infection, biochemical parameters including white blood cell, procalcitonin, C-reactive protein were not significantly different between two groups (all P>0.05). All patients of both groups achieved clinical cure without death. Compared with the simple drainage group after closed thoracic drainage, the continuous irrigation plus drainage group had significantly shorter duration of infection parameters returning to normal levels [white blood cell count: (6.8 ± 2.0) days vs.(10.5±3.0) days, t=4.062, P<0.001; procalcitonin: (7.5±1.0) days vs. (9.2±1.9) days, t=3.236, P=0.040; C-reactive protein: (8.8±1.0) days vs. (11.2±1.5) days, t=5.177, P<0.001], meanwhile time in surgical ICU [(4.9±2.5) days vs. (9.9±6.7) days, t=2.935, P=0.006], healing time of fistula [(42.9±12.5) days vs. (101.8±53.2) days, t=4.187, P=0.001] and total postoperative hospital stay [(62.3±15.8) days vs. (119.7 ±59.4) days, t=3.634, P=0.002] were significantly shorter, and total hospitalization cost was significantly lower (median 86 000 yuan vs. 124 000 yuan, Z=2.063, P=0.040) in the continuous irrigation plus drainage group. CONCLUSION: The continuous closed thoracic drainage with 0.9% sodium chloride solution can accelerate infection control and remission of EJAF patients complicated with mediastinal, thoracic and abdominal infections, and shorten the healing time of anastomotic fistula.

Endoscopic Closure of Gastrointestinal Fistulae and Leaks.

The development of new endoscopic techniques, such as gastrointestinal (GI) stenting, full-thickness suturing, clip application, and use of tissue adhesives, has had a significant impact on management of GI fistulae. These techniques have shown promising results, but further study is needed to optimize the efficacy of long-term closure. The advancement of endoscopic techniques, including the use of the lumen apposing metal stent (LAMS), has allowed for the deliberate creation of fistula tracts to apply endoscopic therapy that previously could not be achieved. This article examines the rapidly evolving area of endoscopic fistula closure and its relationship to LAMS.

Respiratory-digestive tract fistula: two-center retrospective observational study.

Background Aerodigestive fistulae can be defined as abnormal communications between the gastrointestinal tract and the respiratory tract. Choking after meals, coughing, feeding difficulties, tachycardia, and persistent pneumonia are the main presentations. The aim of our study was to review our experience in the management of 27 cases of acquired aerodigestive fistulae of different types, levels, and management. Methods We conducted a retrospective observational study on 27 cases of fistulae between the respiratory and digestive tracts, which were managed in 2 hospitals in Saudi Arabia in the last 5 years. The patients comprised 16 females and 11 males, with a mean age of 29 years (range 17-67 years). Results The most common aerodigestive tract fistula was tracheoesophageal in 8 patients, followed by esophagobronchial in 6, and esophagopleural in 5. Four postendoscopic fistulae were included. The least common were gastropleural and esophagopulmonary fistulae. The most common etiologies were iatrogenic and esophageal cancer, and the least common was blunt chest trauma. The main presentations were fever, chocking after or during meals, and tachycardia. We used various modalities of treatment: conservative, cervical repair, thoracoabdominal repair, hybrid insertion of a T-tube, endoscopic esophageal stenting, and endoscopic clipping of the fistulous tract. During follow-up, 6 patients died due to advanced esophageal cancer in 5 and upper airway obstruction after iatrogenic tracheobronchial fistula in one. Conclusion Acquired aerodigestive fistula is a devastating condition that should be managed early and aggressively by a multidisciplinary team.

Efficacy of Medical Therapies for Fistulizing Crohn's Disease: Systematic Review and Meta-analysis.

BACKGROUND & AIMS: Fistulas are debilitating complications of Crohn's disease (CD) that affect up to 50% of patients. We conducted a systematic review and meta-analysis of randomized controlled trials to assess the efficacy of treatments for fistulizing CD. METHODS: We searched publication databases from inception through December 13, 2016 for trials comparing the efficacy of a therapeutic agent (single or combination) with placebo or another active therapy in adult patients with any form of fistulizing CD. The Cochrane risk of bias tool was used to assess the methodological quality of trials; the overall quality of evidence was evaluated using GRADE. Primary outcomes included induction and maintenance of fistula response and remission. Pooled risk ratios (RRs) and 95% CIs were calculated for each outcome. RESULTS: We analyzed data from 27 trials; most studies (21/27) focused on patients with perianal fistulizing CD. We found moderate-quality evidence to support the efficacy of tumor necrosis factor (TNF) antagonists (RR, 2.01; 95% CI, 1.36-2.97), particularly infliximab, ustekinumab (RR, 1.77; 95% CI, 0.93-3.37), and mesenchymal stem cell therapy (RR, 1.31; 95% CI, 0.98-1.73) for induction of fistula remission. We found low-quality evidence for the efficacy of vedolizumab and immunosuppressives. There was also low-quality evidence to support the efficacy of combination therapy with TNF antagonists and antibiotics vs a TNF antagonist alone. CONCLUSION: In a systematic review and meta-analysis of 27 controlled trials, we found TNF antagonists to be effective for induction and maintenance of perianal fistula response and remission. There are few data on the effects on internal fistulae. Further studies are needed, particularly for ustekinumab, vedolizumab, and stem cell therapies, in patients with fistulizing CD.

Fistula Following Laparoscopic Sleeve Gastrectomy: a Proposed Classification and Algorithm for Optimal Management.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is an accepted restrictive procedure with a hormonal component. There is no definitive course of treatment for post-LSG fistula; it remains a feared complication. We aimed to classify post-LSG fistulas and propose an algorithm to optimize their treatment. METHODS: Following primary and revisional LSG in obese patients, a retrospective observational study of fistulas was undertaken. Radiological studies were performed to identify anatomically distinct types of fistulas. An algorithm was elaborated for the classification and evolving treatment of each type of fistula. RESULTS: Twenty post-LSG fistulas were studied (13 [2.5%] from our center, 7 referred) with a mean body mass index of 43.1 ± 10.2 kg/m2 (32.0-76.0) and mean age of 33.1 ± 11.4 years (20.0-56.0). In all cases, the clinically suspected diagnosis was radiologically confirmed by water-soluble upper gastrointestinal series and double-contrast abdomino-pelvic CT scan. Three anatomical fistula types were characterized: type I, a small leak with no collection; type II, a leak with associated intra-abdominal abscess; and type III, a leak with multiple internal or external abscesses, a complex fistula. In accord with our algorithm, patients without sepsis received conservative treatment initially; this was sufficient for type I leaks. Type II abscesses received internal or external percutaneous drainage, and in some cases, stenting or endoprosthesis. Surgery was reserved for failure of conservative options and type III fistula. In cases of sepsis, surgery was mandatory. CONCLUSION: A radiologically defined, anatomically based classification system and treatment algorithm proved effective in clinical management of post-LSG fistula.

Fístula hepatocólica tratada con el nuevo dispositivo de cierre endoscópico Padlock(R) / Hepatocolic fistula managed with a novel Padlock(R) device for endoscopic closure

El avance de la terapéutica endoscópica está permitiendo abordar patologías que hasta hace poco quedaban reservadas al tratamiento quirúrgico, como las fístulas digestivas. El sistema Padlock(R) consiste en un clip de nitinol introducido recientemente para terapéutica endoscópica. Hasta el momento, son pocas las comunicaciones sobre su utilización en la práctica diaria. Presentamos un caso de fístula colónica tratada mediante este nuevo sistema de clip endoscópico de nitinol (AU)

Recent advances in endoscopic therapeutics allow conditions such as fistulas of the digestive system to be treated endoscopically. These cases were recently managed with surgery. The Padlock(R) system includes a nitinol clip that was recently introduced for endoscopic therapy. There are few reports with regard to its use in the daily clinical practice. We report a case of a colonic fistula that was endoscopically managed with this novel over-the-scope nitinol clip system (AU)

[Prevention, diagnosis and treatment of perioperative complications of bariatric and metabolic surgery].

Surgical operation in treating obesity and type 2 diabetes is popularizing rapidly in China. Correct prevention and recognition of perioperation-related operative complications is the premise of ensuring surgical safety. Familiar complications of the operation include deep venous thrombosis, pulmonary artery embolism, anastomotic bleeding, anastomotic fistula and marginal ulcer. The prevention of deep venous thrombosis is better than treatment. The concrete measures contain physical prophylaxis (graduated compression stocking and intermittent pneumatic compression leg sleeves) and drug prophylaxis (unfractionated heparin and low molecular heparin), and the treatment is mainly thrombolysis or operative thrombectomy. The treatment of pulmonary artery embolism includes remittance of pulmonary arterial hypertension, anticoagulation, thrombolysis, operative thrombectomy, interventional therapy and extracorporeal membrane oxygenation (ECMO). Hemorrhage is a rarely occurred but relatively serious complication after bariatric surgery. The primary cause of anastomotic bleeding after laparoscopic gastric bypass is incomplete hemostasis or weak laparoscopic repair. The common bleeding site in laparoscopic sleeve gastrectomy is gastric stump and close to partes pylorica, and the bleeding may be induced by malformation and weak repair technique. Patients with hemodynamic instability caused by active bleeding or excessive bleeding should timely received surgical treatment. Anastomotic fistula in gastric bypass can be divided into gastrointestinal anastomotic fistula and jejunum-jejunum anastomotic fistula. The treatment of postoperative anastomotic fistula should vary with each individual, and conservative treatment or operative treatment should be adopted. Anastomotic stenosis is mainly related to the operative techniques. Stenosis after sleeve gastrectomy often occurs in gastric angle, and the treatment methods include balloon dilatation and stent implantation, and surgical treatment should be performed when necessary. Marginal ulcer after gastric bypass is a kind of peptic ulcer occurring close to small intestine mucosa in the junction point of stomach and jejunum. Ulcer will also occur in the vestige stomach after laparoscopic sleeve gastrectomy, and the occurrence site locates mostly in the gastric antrum incisal margin. Preoperative anti-HP (helicobacter pylorus) therapy and postoperative continuous administration of proton pump inhibitor (PPI) for six months is the main means to prevent and treat marginal ulcer. For patients on whom conservative treatment is invalid, endoscopic repair or surgical repair should be considered. Different surgical procedures will generate different related operative complications. Fully understanding and effectively dealing with the complications of various surgical procedures through multidisciplinary cooperation is a guarantee for successful operation.

[Value of endoscopy application in the management of complications after radical gastrectomy for gastric cancer].

Endoscopy plays an important role in the diagnosis and treatment of postoperative complications of gastric cancer. Endoscopic intervention can avoid the second operation and has attracted wide attention. Early gastric anastomotic bleeding after gastrectomy is the most common. With the development of technology, emergency endoscopy and endoscopic hemostasis provide a new treatment approach. According to the specific circumstances, endoscopists can choose metal clamp to stop bleeding, electrocoagulation hemostasis, local injection of epinephrine or sclerotherapy agents, and spraying specific hemostatic agents. Anastomotic fistula is a serious postoperative complication. In addition to endoscopically placing the small intestine nutrition tube for early enteral nutrition support treatment, endoscopic treatment, including stent, metal clip, OTSC, and Over-stitch suture system, can be chosen to close fistula. For anastomotic obstruction or stricture, endoscopic balloon or probe expansion and stent placement can be chosen. For esophageal anastomotic intractable obstruction after gastroesophageal surgery, radial incision of obstruction by the hook knife or IT knife, a new method named ERI, is a good choice. Bile leakage caused by bile duct injury can be treated by placing the stent or nasal bile duct. In addition, endoscopic methods are widely used as follows: abdominal abscess can be treated by the direct intervention under endoscopy; adhesive ileus can be treated by placing the catheter under the guidance of endoscopy to attract pressure; alkaline reflux gastritis can be rapidly diagnosed by endoscopy; gastric outlet obstruction mainly caused by cancer recurrence can be relieved by metal stent placement and the combination of endoscopy and X-ray can increase success rate; pyloric dysfunction and spasm caused by the vagus nerve injury during proximal gastrectomy can be treated by endoscopic pyloromyotomy, a new method named G-POEM, and the short-term outcomes are significant. Endoscopic submucosal dissection (ESD) allows complete resection of residual gastric precancerous lesions, however it should be performed by the experienced endoscopists.

Abscess due to perforated appendicitis: factors associated with successful percutaneous drainage.

BACKGROUND: Percutaneous drainage is the standard treatment for perforated appendicitis with abscess. We studied factors associated with complete resolution (CR) with percutaneous drainage alone. METHODS: Ninety-eight patients underwent percutaneous drainage for acute appendicitis complicated by abscess (October 1990 to September 2010). CR was defined as clinical recovery, resolution of the abscess on imaging, and drain removal without recurrence. Patients achieving CR were compared with patients not achieving CR. RESULTS: The rate of CR was 78.6% (n = 77). Abscess grade was the only radiological factor associated with CR (P = .007). The CR rate was higher with transgluteal drainage (90.9% vs 79.2%) than with other anatomic approaches (P = .018) and higher with computed tomography-guided drainage than with ultrasound-guided drainage (82.7% vs 64.3%, P = .046). CONCLUSION: CR was more likely to be achieved in patients with lower abscess grade, computed tomography-guided drainage, and a transgluteal approach.

THE OVER-THE-SCOPE-CLIP FOR THE TREATMENT OF THE DIGESTIVE TUBE LEAKS AND TEARS: A CASE-SERIES. / LIJECENJE OSTECENJA PROBAVNE CIJEVI PRIMJENOM ENDOSKOPSKE STEZALJKE: PRIKAZ SERIJE BOLESNIKA.

Digestive tube damages represent a therapeutic challenge for the gastrointestinal endoscopists. Recenty, a novel device ­ the-over-the-scope clip (OTSC) ­ has been introduced for non-surgical treatment of gastrointestinal perforations, fi stula, anastomotic leaks and refractory gastrointestinal bleeds. This study aimed to evaluate the therapeutic effi cacy of OTSC in our case series. A total of nine patients were included (six males, medain age 72 years, range 58-86). The indications were upper gastrointestinal bleeding (refractory to standard endoscopic treatment: fi ve patients, a vessel with a large caliber: one patient), fi stula in two patients, and iatrogenic perforation of the sigmoid colon in one patient. Atraumatic and traumatic versions of OTSCs with twin graspers were used. All of the patients were treated with only one OTSC, and none of the patients required additional endoscopic treatment. The OTSC procedure had 100% technical success. In a subgroup of patients with perforation and fi stulae, the clinical success was 67%, whereas in those with the bleedings it was 50%. The median follow-up was 34 days (range: 3-452). OTSC is a safe and effective device for closure of perforations and leaks. However therapeutic effi cacy was subopimal in patients with the upper gastrointestinal bleedings possibly due to the application of the sharp-teeth OTSC.