Clinical Trials Logo

Clinical Trial Summary

Obesity is a major health problem in western countries, and sleeve gastrectomy has proven its effectiveness on weight loss and improvement of comorbidities related to obesity. The main complication is the occurrence of upper fistula (2%), and may be responsible of several deaths. There is no consensus on medical, radiological and surgical management of fistula. It depends on the resources of each center and is based on a low level evidence The inconstant efficacy of the endoscopic treatment by closing fistula (digestive stents, clips, glue) motivates a new endoscopic approach. It consists of an internal drainage of the collection by using double pigtail stents through the fistulous orifice.


Clinical Trial Description

Partially or fully covered stents are the most used method, but are not supported by any comparative studies. Their results are inconstant and the closure rate is estimated between 15 and 100%, with a hazardous median healing time. This method is associated with frequent complications, such as spontaneous migrations, impactions or ulcerations responsible for potentially fatal hematemesis. The preliminary results of using OTSC clips (OVESCO®) seem encouraging, but this technique requires external drainage to obtain a collection free from infection. A new approach is to perform an internal drainage of the peri-orificial collection by using double pigtail stents through the fistulous orifice and to direct the fistula closure from the outside to the inside. This endoscopic treatment, combined with nutritional support and initial antibiotic therapy, allows rapid weaning of external drainage and short healing times. CT and endoscopic evaluation are needed at the sixth week for stents removal in the event of a favorable evolution. In the opposite case, a second endoscopic treatment is performed. In case of unfavorable evolution, a radical surgical treatment, in the absence of endoscopic alternative, will be achieved. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04049955
Study type Interventional
Source Centre Hospitalier Universitaire, Amiens
Contact
Status Completed
Phase N/A
Start date August 1, 2019
Completion date November 1, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03959878 - Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes. N/A
Active, not recruiting NCT04566367 - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer N/A
Recruiting NCT04110613 - RCT: Early Feeding After PEG Placement N/A
Completed NCT03319576 - Early Feeding Following Percutaneous Gastrostomy Tube Placement N/A
Completed NCT03575754 - A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique N/A
Enrolling by invitation NCT06129877 - CHAMP App Feeding Difficulties Repository
Completed NCT04183296 - The Effect of Total Intravenous Anesthesia and Volatile Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Laparoscopic or Robotic Assisted Gastrectomy N/A
Recruiting NCT02909205 - a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised N/A
Recruiting NCT04636099 - Gastrointestinal Surgery Study Group 2001 N/A
Recruiting NCT06464978 - Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy N/A
Not yet recruiting NCT05955534 - Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy N/A
Completed NCT02869321 - Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy Phase 4
Recruiting NCT05205343 - Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
Recruiting NCT03874871 - Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients
Completed NCT03252509 - Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors N/A
Completed NCT04804631 - Tube Feeding in Children Having a Bone Marrow Transplant
Terminated NCT01825564 - Comparison of RightSpot pH Indicator & RightLevel pH Detector With X-Ray Verification for FT or G-Tube Placement N/A
Completed NCT04919577 - Predictive Factors for Roux Stasis Syndrome
Completed NCT04151030 - Endoscopic Direct-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure N/A
Not yet recruiting NCT06431048 - No DIET Trial: Dogmatic Interruption of Enteral nuTrition N/A