“USE OF A FIBRIN ADHESIVE TO REDUCE ESOPHAGOYEJUNAL ANASTOMOSIS DEHISCENCE IN TOTAL GASTRECTOMIES FOR CANCER: RANDOMIZED AND MULTICENTER STUDY”
- Conditions
- ESOPHAGOYEJUNAL ANASTOMOSIS DEHISCENCE IN TOTAL GASTRECTOMIES FOR CANCER
- Registration Number
- 2024-519529-40-00
- Lead Sponsor
- Hospital Germans Trias I Pujol
- Brief Summary
The trial would be conducted with the aim of evaluating the efficacy of fibrin-based adhesive in reducing the incidence of dehiscence in esophagojejunal anastomoses in total gastrectomies for cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 240
Patients of both sexes over 18 years of age.
Diagnosis of gastric cancer with AP of gastric adenocarcinoma and possibility of total gastrectomy with curative intent. Tumors with AP characteristics other than gastric adenocarcinoma are excluded (see ‘Exclusion Criteria’)
Patients undergoing surgery in trial participants hospital centers
understand and accept the trial procedures and sign an informed consent.
Not meeting the inclusion criteria.
Intraoperative diagnosis (during surgery) of non-epithelial neoplasia,metastasis, patients with unresected tumor or undergoing palliative resections.
Use of other sealing or anastomosis reinforcing products other than the drug under study (TISSEEL Solutions for tissue adhesive)
Subjects who are intolerant or have experienced serious adverse events to products made from fibrin adhesive
Pregnant or lactating women
Subjects who are unable to understand the nature of the trial and the procedures they are required to follow.
Failure to sign the informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Suture dehiscence diagnosed within the first seven days after surgery, using clinical and/or radiological parameters. Csendes classification Suture dehiscence diagnosed within the first seven days after surgery, using clinical and/or radiological parameters. Csendes classification
- Secondary Outcome Measures
Name Time Method Type of anastomosis performed: manual, mechanical (circular or linear) Type of anastomosis performed: manual, mechanical (circular or linear)
Amylases in drainage on days 1,3,5,7 postoperatively or until the drainage is removed. Amylases in drainage on days 1,3,5,7 postoperatively or until the drainage is removed.
Leukocytes, procalcitonin, C-reactive protein in blood on days 0,1,3,5,7 postoperatively. Leukocytes, procalcitonin, C-reactive protein in blood on days 0,1,3,5,7 postoperatively.
Day of CT with oral contrast. CT findings according to Goense score Day of CT with oral contrast. CT findings according to Goense score
Postoperative complication and type (Clavien Dindo Classification) Postoperative complication and type (Clavien Dindo Classification)
Need for urgent surgical reintervention Need for urgent surgical reintervention
In-hospital and 90-day mortality In-hospital and 90-day mortality
Date of hospital discharge Date of hospital discharge
Readmissions at 30 and 90 days Readmissions at 30 and 90 days
Trial Locations
- Locations (13)
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
🇪🇸Lleida, Spain
Equip D'assistencia Primaria Vic S.L.P.
🇪🇸Vic, Spain
Hospital Universitari De Girona Doctor Josep Trueta
🇪🇸Girona, Spain
Hospital General De Granollers
🇪🇸Granollers, Spain
Consorci Sanitari Del Maresme
🇪🇸Mataro, Spain
Hospital Universitario De Cruces
🇪🇸Barakaldo, Spain
Consorci Sanitari De Terrassa
🇪🇸Terrassa, Spain
Hospital Germans Trias I Pujol
🇪🇸Badalona, Spain
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Scroll for more (3 remaining)Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida🇪🇸Lleida, SpainMarta GonzálezSite contact+34jo_marta@hotmail.com