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

USE OF A FIBRINE ADHESIVE TO REDUCE THE DEHISCENCE OF ESOFAGOYEYUNAL ANASTOMOSIS IN TOTAL GASTRECTOMIES BY CANCER: RANDOMIZED AND MULTICENTRIC STUDY. - Use of fibrin adhesive in anastomosis

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001778-12-ES

Enrollment

250

Registered

2019-05-17

Start date

2019-04-15

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The dehiscence of the esophagojejunal anastomosis after a total gastrectomy in patients with gastric adenocarcinoma MedDRA version: 20.0 Level: LLT Classification code 10058439 Term: Esophageal anastomosis System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10013121 Term: Diseases of esophagus System Or

Interventions

Trade Name: TISSEEL Product Name: TISSEEL Pharmaceutical Form: Sealant powder INN or Proposed INN: HUMAN THROMBIN CAS Number: 9002-04-4

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Secondary

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manual, mechanical (circular or linear) - Amylases in drainage on days 1,3,5,7 postoperatively or until drainage is withdrawn.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

Measure

Time frame

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manual, mechanical (circular or linear) - Amylases in drainage on days 1,3,5,7 postoperatively or until drainage is withdrawn.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

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Countries

Spain

Contacts

Public ContactServicio de Cirugía General

Fundació Institut d'investigació en Ciències de la Salut germans Trias i Pujol

sarasenti1010@gmail.com34934651200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026