In short
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.
Key points
- Clinical trials investigating HUMAN THROMBIN are focused on surgery-related outcomes, especially reducing dehiscence after total gastrectomy for cancer. The available trial is a Phase 3, randomized, multicenter study with 240 participants. It studies patients who have an esophagojejunal anastomosis, which is the surgical join made after the stomach is removed. The main outcome is suture dehiscence within the first seven days after surgery. The trial uses clinical and radiological checks, plus the Csendes classification, to measure this result.
Trial overview
The available trial investigating HUMAN THROMBIN is a Phase 3, interventional, randomized, multicenter study that is authorised and planned in 240 participants.
The study title says it is about using a fibrin adhesive to reduce esophagojejunal anastomosis dehiscence after total gastrectomy for cancer.
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.
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.
These patients have an esophagojejunal anastomosis, meaning the surgeon creates a connection between the esophagus and the jejunum after the stomach is removed.
The condition being studied is esophagojejunal anastomosis dehiscence, which is the opening or failure of that surgical join.
Trial design and phase
This study is described as randomized, which means participants are assigned by chance to study groups.
It is also multicenter, so it is being carried out in more than one hospital or research site.
Because it is Phase 3, the trial is focused on confirming how well the approach works in a larger group of patients.
What the trials measure
The primary outcome is suture dehiscence diagnosed within the first seven days after surgery.
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.
The trial also uses the Csendes classification to grade the dehiscence if it occurs.
Key terms explained
Interventional means the study tests a treatment or procedure rather than only observing patients.
Enrollment is the number of participants planned for the study, which is 240 in this trial.
Authorised means the trial has official approval to proceed.
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.