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“USE OF A FIBRIN ADHESIVE TO REDUCE ESOPHAGOYEJUNAL ANASTOMOSIS DEHISCENCE IN TOTAL GASTRECTOMIES FOR CANCER: RANDOMIZED AND MULTICENTER STUDY”
EU CTIS ID: 2024-519529-40-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.