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HUMAN THROMBIN

Clinical trials investigating HUMAN THROMBIN are studying its use in surgery, especially to help reduce tissue separation after total gastrectomy for cancer. These trials mainly look at safety and effectiveness in patients with esophagojejunal anastomosis, which is the surgical connection between the esophagus and jejunum.

Table of Contents

Trial overview

The available trial investigating HUMAN THROMBIN is a Phase 3, interventional, randomized, multicenter study that is authorised and planned in 240 participants.[1]

The study title says it is about using a fibrin adhesive to reduce esophagojejunal anastomosis dehiscence after total gastrectomy for cancer.[1]

The brief summary states that the main aim is to evaluate the efficacy of a fibrin-based adhesive in lowering the rate of dehiscence in this surgical setting.[1]

Who is studied in these trials

The trial targets people undergoing total gastrectomy for cancer, which means removal of the whole stomach because of cancer.[1]

These patients have an esophagojejunal anastomosis, meaning the surgeon creates a connection between the esophagus and the jejunum after the stomach is removed.[1]

The condition being studied is esophagojejunal anastomosis dehiscence, which is the opening or failure of that surgical join.[1]

Trial design and phase

This study is described as randomized, which means participants are assigned by chance to study groups.[1]

It is also multicenter, so it is being carried out in more than one hospital or research site.[1]

Because it is Phase 3, the trial is focused on confirming how well the approach works in a larger group of patients.[1]

What the trials measure

The primary outcome is suture dehiscence diagnosed within the first seven days after surgery.[1]

The study uses clinical and/or radiological parameters, which means doctors may look at symptoms, examination findings, and imaging tests to judge whether the join has opened.[1]

The trial also uses the Csendes classification to grade the dehiscence if it occurs.[1]

Key terms explained

Interventional means the study tests a treatment or procedure rather than only observing patients.[1]

Enrollment is the number of participants planned for the study, which is 240 in this trial.[1]

Authorised means the trial has official approval to proceed.[1]

Fibrin adhesive is the treatment approach mentioned in the trial title and summary, but the source data do not provide more detail about its composition or how it works.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2024-519529-40-00Phase 3Esophagojejunal anastomosis dehiscence in total gastrectomies for cancerAuthorised240

FAQ

  • What is being studied in HUMAN THROMBIN trials? The trial data focus on whether a fibrin-based adhesive can reduce suture separation after surgery. The goal is to see if it lowers the risk of esophagojejunal anastomosis dehiscence, which means the surgical join opens or leaks.
  • Who can take part in these trials? The studied population is patients having total gastrectomy for cancer. These are people who need surgery that creates an esophagojejunal anastomosis.
  • What phase is the trial? The trial is in Phase 3. This phase usually studies how well a treatment works in a larger group of patients and helps confirm earlier findings.
  • What outcome is the trial measuring? The main outcome is suture dehiscence within the first seven days after surgery. The trial uses clinical and/or radiological findings, along with the Csendes classification, to judge this outcome.
  • Is the trial randomized and multicenter? Yes. The trial is described as randomized and multicenter, which means patients are assigned by chance and the study is carried out in more than one center.

Ongoing Clinical Trials on HUMAN THROMBIN

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

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Anastomosis: A surgical connection between two parts of the body, such as the esophagus and the jejunum.
  • Esophagojejunal anastomosis: The surgical join between the esophagus and the jejunum after the stomach is removed.
  • Dehiscence: When a surgical wound or join opens up instead of staying closed.
  • Total gastrectomy: An operation to remove the whole stomach.
  • Cancer: A disease in which abnormal cells grow and can damage body tissues.
  • Randomized: Patients are assigned to treatment groups by chance, not by choice.
  • Multicenter: A study done in more than one hospital or research site.
  • Phase 3: A later stage of clinical research that tests how well a treatment works in a larger group.
  • Primary outcome: The main result the trial is designed to measure.
  • Radiological parameters: Findings from imaging tests, such as scans or X-rays, used to check for a problem.
  • Csendes classification: A system used to grade or classify the severity of dehiscence.

References

  1. https://clinicaltrials.gov/study/2024-519529-40-00