Overview
Sponsor-declared trial summary
ESOPHAGOYEJUNAL ANASTOMOSIS DEHISCENCE IN TOTAL GASTRECTOMIES FOR CANCER
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.
Key facts
- Sponsor
- Hospital Germans Trias I Pujol
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2025-01-15
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519529-40-00
- EudraCT number
- 2018-001778-12
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
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.
Conditions and MedDRA coding
ESOPHAGOYEJUNAL ANASTOMOSIS DEHISCENCE IN TOTAL GASTRECTOMIES FOR CANCER
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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.
Exclusion criteria 7
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Suture dehiscence diagnosed within the first seven days after surgery, using clinical and/or radiological parameters. Csendes classification
Secondary endpoints 9
- 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.
- 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
- Postoperative complication and type (Clavien Dindo Classification)
- Need for urgent surgical reintervention
- In-hospital and 90-day mortality
- Date of hospital discharge
- Readmissions at 30 and 90 days
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
TISSEEL Soluciones para adhesivo tisular
PRD2955663 · Product
- Active substance
- Aprotinin
- Pharmaceutical form
- SOLUTION FOR SEALANT
- Route of administration
- APPLICATION
- Max daily dose
- 10 ml millilitre(s)
- Max total dose
- 10 ml millilitre(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AK, B02BC30 — TISSUE ADHESIVES, -
- Marketing authorisation
- 78896
- MA holder
- BAXTER, S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Germans Trias I Pujol
- Sponsor organisation
- Hospital Germans Trias I Pujol
- Address
- Carretera Canyet 1a Planta
- City
- Badalona
- Postcode
- 08916
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Germans Trias I Pujol
- Contact name
- Yolanda Soler Gonzalez
Public contact point
- Organisation
- Hospital Germans Trias I Pujol
- Contact name
- Yolanda Soler Gonzalez
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 240 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_HUGTP-EC_2020-003 protocolICFApoba | 1 |
| Recruitment arrangements (for publication) | Not_Applicable_Document_YS | 1 |
| Subject information and informed consent form (for publication) | L1_ICF version 2_06-02-2019 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | H1_ficha tecnica Tisseel | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-09 | Spain | Acceptable 2025-01-15
|
2025-01-15 |