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Study on Fibrin Adhesive to Prevent Leaks After Stomach Cancer Surgery Using Aprotinin, Human Fibrinogen, and Calcium Chloride Dihydrate in Patients Undergoing Total Gastrectomy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called esophagojejunal anastomosis dehiscence, which can occur after a surgery known as total gastrectomy for treating gastric cancer. This condition involves a leak at the surgical connection between the esophagus and the small intestine. The study is testing a treatment called TISSEEL, a fibrin-based adhesive, which is used to help seal tissues during surgery. TISSEEL contains several substances, including aprotinin, human fibrinogen, calcium chloride dihydrate, human thrombin, and human coagulation factor XIII.

The purpose of the study is to see if using TISSEEL can reduce the chances of developing esophagojejunal anastomosis dehiscence after surgery. Participants in the study will undergo surgery as part of their treatment for gastric cancer. During the surgery, TISSEEL will be applied to help prevent leaks at the surgical site. The study will monitor participants for any signs of leaks or other complications in the days following the surgery.

The study will last for a period of time, with participants being observed for any complications or the need for additional surgery. The goal is to determine if TISSEEL is effective in reducing the risk of leaks and improving recovery after surgery for gastric cancer. Participants will be monitored closely to ensure their safety and to gather information on the effectiveness of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must understand and accept the trial procedures and sign an informed consent form.

    Eligibility includes being over 18 years of age, having a diagnosis of gastric cancer with the possibility of total gastrectomy, and undergoing surgery at a participating hospital center.

  2. Step 2

    Surgery and application of adhesive

    During the surgery, a fibrin-based adhesive called TISSEEL is applied. This adhesive contains substances such as aprotinin, human fibrinogen, calcium chloride dihydrate, human thrombin, and human coagulation factor xiii.

    The adhesive is used to reduce the risk of dehiscence, which is a complication where the surgical connection between the esophagus and the jejunum may come apart.

  3. Step 3

    Postoperative monitoring

    After surgery, the patient is monitored for signs of suture dehiscence within the first seven days. This is done using clinical and radiological assessments.

    The type of surgical connection (anastomosis) performed is recorded, whether manual or mechanical.

  4. Step 4

    Laboratory tests and imaging

    Blood tests are conducted on days 0, 1, 3, 5, and 7 after surgery to measure levels of leukocytes, procalcitonin, and C-reactive protein.

    Amylase levels in drainage are checked on days 1, 3, 5, and 7, or until the drainage is removed.

    A CT scan with oral contrast may be performed, and findings are evaluated using the Goense score.

  5. Step 5

    Complication assessment

    Any postoperative complications are classified using the Clavien-Dindo classification system.

    The need for urgent surgical reintervention is assessed if complications arise.

  6. Step 6

    Discharge and follow-up

    The date of hospital discharge is recorded.

    The patient is monitored for readmissions at 30 and 90 days post-surgery.

    In-hospital and 90-day mortality rates are also tracked as part of the study outcomes.

Who can join the trial?

6 criteria

  • Patients must be **over 18 years old**.
  • Patients must have a **diagnosis of gastric cancer**. This means they have been told they have cancer in their stomach.
  • The specific type of cancer must be **gastric adenocarcinoma**, which is a common type of stomach cancer. Other types of tumors are not included.
  • Patients must be able to have a **total gastrectomy**, which is a surgery to remove the entire stomach, with the goal of curing the cancer.
  • Patients must have their surgery at one of the hospitals participating in the trial.
  • Patients must **understand and agree** to the trial procedures and sign a document called an **informed consent**. This means they agree to take part in the study after being told all the details.

Who cannot join the trial?

5 criteria

  • Patients who are not undergoing a total gastrectomy for cancer. A total gastrectomy is a surgery where the entire stomach is removed.
  • Patients who do not have an esophagojejunal anastomosis. This is a surgical connection made between the esophagus and the jejunum, which is part of the small intestine.
  • Patients who are not at risk of dehiscence. Dehiscence is when a surgical wound or connection opens up or fails to heal properly.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Fibrin Adhesive is a special glue used in surgeries to help tissues stick together. In this trial, it is being tested to see if it can help reduce the risk of leaks where the esophagus and small intestine are joined together after stomach removal surgery for cancer. The goal is to see if using this adhesive can make the healing process safer and more effective.

What is already known about the treatment

Fibrin Adhesive – This medication is administered topically during surgical procedures. It is currently being studied in clinical trials to assess its effectiveness in reducing complications after surgery, specifically for esophagojejunal anastomosis dehiscence following total gastrectomies for cancer. The main therapeutic indication is to support tissue healing and reduce the risk of leaks at surgical connection sites. At the molecular level, fibrin adhesive works by mimicking the final stages of the blood clotting process, forming a stable clot that helps seal tissues together. It is classified as a hemostatic agent, which aids in stopping bleeding and promoting wound healing.

Investigated diseases

Esophagojejunal Anastomosis Dehiscence in Total Gastrectomies for Cancer – This condition occurs when there is a failure in the surgical connection between the esophagus and the jejunum following the complete removal of the stomach due to cancer. The dehiscence refers to the separation or opening of the surgical join, which can lead to leakage of contents from the digestive tract into the surrounding area. This complication typically manifests within the first week after surgery. Symptoms may include pain, fever, and signs of infection or inflammation. The condition requires careful monitoring and management to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519529-40-00Estimated enrolment240 patientsSponsorHospital Germans Trias I Pujol

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