Clinical trial · Interventional
Tisseel® as a Reinforcement of Esophagojejunal Anastomoses
The Use of Fibrin Glue Sealant (Tisseel®) as a Reinforcement of Esophagojejunal Anastomoses Will Decrease the Rate of Anastomotic Leak.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: The dehiscence of esophagojejunal anastomoses is one of the most serious complications after total gastrectomy in patients with gastric cancer. Any method of avoiding this problem will affect not only the postoperative course but also the prognostic of disease. Methods: This is a prospective, randomized and multicenter trial, within the Spanish EURECCA Esophagogastric Cancer Group, to investigate the efficacy of Tisseel® in reducing the rate of esophagojejunal anastomosis leakage in patients with gastric cancer. The rate of anastomosis leak will be measured with clinical, radiological and analytic parameters. Objective: Analyze the efficacy of Tisseel® as a reinforcement in reducing the rate of anastomotic esophagojejunal anastomoses.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Tisseel | Device | — | UNRESOLVED |
| Tisseel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Tisseel®
- description
- Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). In the arm "Tisseel®" surgeon dispenses the product all over the anastomosis. The rest of the surgical procedure is as usual.
- interventionNames
- Drug: Tisseel
- type
- OTHER
- label
- no Tisseel®
- description
- Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). In the arm " noTisseel®" surgeon performs the surgical procedure as usual.
- interventionNames
- Device: No Tisseel
Primary outcomes (1)
- measure
- Rate of esophagojejunal anastomotic leak in immediate postoperative period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years diagnosed with gastric adenocarcinoma and scheduled for a total gastrectomy with curative intent in EURECCA Esophagogastric Cancer Group who agree to participate in the study and sign the informed consent Exclusion Criteria: * Patients with non-epithelial neoplasms, with metastases, not resected or undergoing palliative resections. Patients who do not sign informed consent.
References
Publications (31)
- BACKGROUNDAurello P, Magistri P, D'Angelo F, Valabrega S, Sirimarco D, Tierno SM, Nava AK, Ramacciato G. Treatment of esophagojejunal anastomosis leakage: a systematic review from the last two decades. Am Surg. 2015 May;81(5):450-3. PMID 25975326
- BACKGROUNDMigita K, Takayama T, Matsumoto S, Wakatsuki K, Enomoto K, Tanaka T, Ito M, Nakajima Y. Risk factors for esophagojejunal anastomotic leakage after elective gastrectomy for gastric cancer. J Gastrointest Surg. 2012 Sep;16(9):1659-65. doi: 10.1007/s11605-012-1932-4. Epub 2012 Jun 12. PMID 22688419
- BACKGROUNDDe Stefano A, Bettarini F, Di Mare G, Neri A. [Enteric anastomosis and Tachosil(R)]. Minerva Chir. 2011 Jun;66(3):183-8. Italian. PMID 21666554
- BACKGROUNDYuan Y, Zeng X, Hu Y, Xie T, Zhao Y. Omentoplasty for esophagogastrostomy after esophagectomy. Cochrane Database Syst Rev. 2012 Nov 14;11:CD008446. doi: 10.1002/14651858.CD008446.pub2. PMID 23152259
- BACKGROUNDBorst HG, Haverich A, Walterbusch G, Maatz W. Fibrin adhesive: an important hemostatic adjunct in cardiovascular operations. J Thorac Cardiovasc Surg. 1982 Oct;84(4):548-53. PMID 6981733
- BACKGROUNDKjaergard HK, Fairbrother JE. Controlled clinical studies of fibrin sealant in cardiothoracic surgery--a review. Eur J Cardiothorac Surg. 1996;10(9):727-33. doi: 10.1016/s1010-7940(96)80332-0. PMID 8905274
- BACKGROUNDMatthew TL, Spotnitz WD, Kron IL, Daniel TM, Tribble CG, Nolan SP. Four years' experience with fibrin sealant in thoracic and cardiovascular surgery. Ann Thorac Surg. 1990 Jul;50(1):40-3; discussion 43-4. doi: 10.1016/0003-4975(90)90080-p. PMID 2369228
- BACKGROUNDBonanomi G, Prince JM, McSteen F, Schauer PR, Hamad GG. Sealing effect of fibrin glue on the healing of gastrointestinal anastomoses: implications for the endoscopic treatment of leaks. Surg Endosc. 2004 Nov;18(11):1620-4. doi: 10.1007/s00464-004-8803-3. Epub 2004 Oct 11.