Table of Contents

• Trial overview
• Study population and setting
• Study design and phase
• Main outcome being measured
• What this trial may mean for patients

Trial overview

Only one trial record was provided for HUMAN COAGULATION FACTOR XIII. It is an authorised, interventional, Phase 3 study with 240 planned participants.^[1]

The study title says it is a randomized and multicenter trial looking at the use of a fibrin adhesive to reduce esophagojejunal anastomosis dehiscence after total gastrectomy for cancer.^[1]

Study population and setting

The target condition is esophagojejunal anastomosis dehiscence, which means the surgical join between the esophagus and jejunum opens after surgery.^[1]

The study population is people who have a total gastrectomy for cancer, which means surgery to remove the whole stomach because of cancer.^[1]

The trial is multicenter, so it is planned to run in more than one study site.^[1]

Study design and phase

This is an interventional study, meaning the researchers are testing a treatment strategy rather than only observing patients.^[1]

The phase is Phase 3, which usually means the treatment is being studied in a larger group to check how well it works.^[1]

The trial status is authorised, and the planned enrollment is 240 participants.^[1]

Main outcome being measured

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

The study uses clinical and/or radiological parameters to detect this problem, and it also uses the Csendes classification to describe it.^[1]

This means the researchers are checking both symptoms or exam findings and imaging tests to see whether the surgical join stays closed after the operation.^[1]

What this trial may mean for patients

For patients having surgery for stomach cancer, the main question is whether the studied adhesive approach can lower the risk of an early opening at the surgical join.^[1]

The trial does not provide results in the source data, so the information here is about the study plan, not the final outcome.^[1]

Because the trial is focused on a specific surgical problem after cancer surgery, it is most relevant to patients who are undergoing total gastrectomy with an esophagojejunal connection.^[1]