Tisseel® as a Reinforcement of Esophagojejunal Anastomoses

NCT03733639 | Unknown Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: Tisseel
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer; Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• Rate of esophagojejunal anastomotic leak in immediate postoperative period

  Clinical or radiological (see anex 1: Score Goense) evidence of esophagojejunal anastomotic leak.

  7 days

Secondary Outcomes (11)

• Amylases level in drainage

  days 1,3,5,7 postoperatively

• CRP (C-reactive protein) in blood

  days 1,3,5,7 postoperatively

• Procalcitonin in blood

  days 1,3,5,7 postoperatively

• White cell levels in blood

  days 1,3,5,7 postoperatively

• Results of Computed Tomography with oral contrast.

  between 3th and 5th postoperative day

Study Arms (2)

Tisseel®

ACTIVE COMPARATOR

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.

Drug: Tisseel

no Tisseel®

OTHER

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.

Device: No Tisseel

Interventions

Tisseel DRUG

Reinforcement of esophagojejunal anastomoses after total gastrectomy with the product.

Tisseel®

No Tisseel DEVICE

No reinforcement of esophagojejunal anastomoses after total gastrectomy

no Tisseel®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with non-epithelial neoplasms, with metastases, not resected or undergoing palliative resections. Patients who do not sign informed consent.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Elisenda Garsot Savall

Badalona, Barcelona, 08016, Spain

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Stomach Neoplasms; Anastomotic Leak

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Elisenda Garsot

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisenda Garsot

CONTACT

0034934978803; egarsot@yahoo.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients won't know if his anastomoses has been reinforced with Tisseel®.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Upper Gastrointestinal Surgery Unit

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: November 7, 2018
• Study Start: July 21, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

ES (1)