THE ROLE OF A FIBRIN BASED GLUE TO REDUCE DEHISCENCE IN ESOPHAGOJEJUNAL ANASTOMOSIS

Phase 1

• Conditions: The dehiscence of the esophagojejunal anastomosis after a total gastrectomy in patients with gastric adenocarcinoma; MedDRA version: 20.0 Level: LLT Classification code 10013121 Term: Diseases of esophagus System Organ Class: 100000004856; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]; MedDRA version: 20.0 Level: LLT Classification code 10058439 Term: Esophageal anastomosis System Organ Class: 100000004865; MedDRA version: 20.1 Level: LLT Classification code 10075515 Term: Stoma site leakage System Organ Class: 100000004863

• Registration Number: EUCTR2018-001778-12-ES
• Lead Sponsor: Fundació Institut de Recerca en Ciències de la Salut Germans Trias i Pujol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

- Patients of both sexes older than 18 years.
- Diagnosis of gastric adenocarcinoma with the possibility of total gastrectomy with curative intention.
- Patients with reference centers in the participating autonomies.
- Understand and accept the trial procedures and sign an informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

- Failure to meet the inclusion criteria.
- Diagnosis of non-epithelial neoplasia, metastasis, patients with unresected tumor or undergoing palliative resections.
- Subjects who have intolerance or have presented serious adverse reactions to products formed with a fibrin adhesive.
- Pregnant or lactating women
- Subjects who are not able to understand the nature of the essay and the procedures that they are asked to follow.
- Do not sign informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effectiveness of a fibrin-based tissue adhesive (Tisseal) to reduce the incidence of dehiscence in esophagojejunal anastomoses in total gastrectomies due to cancer.;Secondary Objective: Not applicable;Primary end point(s): Dehiscence of suture diagnosed in the postoperative period using clinical and / or radiological parameters. Classification of Csendes;Timepoint(s) of evaluation of this end point: A week of follow-up (after surgery)

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - Type of anastomosis performed: manual, mechanical (circular or linear)<br> - Amylases in drainage on days 1,3,5,7 postoperatively or until drainage is withdrawn.<br> - Leukocytes, procalcitonin, C-reactive protein in blood on days 0,1,3,5,7 postoperatively.<br> - CT realization day with oral contrast. Findings of the TC according to the Goense score<br> - Postoperative complication and type (Classification of Clavien Dindo)<br> - Need for urgent surgical re-intervention<br> - In-hospital and 90-day mortality<br> - Date of hospital discharge<br> - Re-entries at 30 and 90 days<br> ;Timepoint(s) of evaluation of this end point: A follow-up of 90 days after surgery