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Search / Trial NCT05404256

Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · May 30, 2022

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Tissue Patch Tm Radical Gastrectomy Postoperative Pancreatic Fistula

ClinConnect Summary

This clinical trial is studying the effectiveness of a product called TissuePatchTM in preventing a serious complication known as postoperative pancreatic fistula after surgery for gastric cancer. A pancreatic fistula occurs when fluid leaks from the pancreas, which can lead to additional health issues and even be life-threatening. The researchers want to see if using TissuePatchTM, a special surgical sealant that helps close and protect wounds, can lower the chances of this complication happening after surgery.

To participate in this trial, individuals need to be between 18 and 75 years old and have a specific type of stomach cancer called gastric adenocarcinoma. They should not have any other serious health issues that could interfere with the surgery or their recovery. Participants will receive standard treatment for gastric cancer, and their progress will be closely monitored to see if TissuePatchTM helps reduce the risk of developing a pancreatic fistula. If you or a loved one are eligible, this trial could provide valuable information that may improve care for patients undergoing gastric cancer surgery in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Histological confirmation of gastric adenocarcinoma
  • Stage cT1-4a, N0-3, M0 (according to the 8th AJCC TNM staging system)
  • For locally advanced tumors (cT3-4aN+M0), preoperative completion of all three cycles of chemotherapy (SOX)
  • 18-75 years old
  • No incurable factors such as cancer cell metastasis in other organs
  • Written informed consent signed voluntarily
  • Exclusion Criteria:
  • Assessment of preoperative or intraoperative requiring pancreatic resection
  • Gastric cancer-related emergency surgery
  • Gastric stump carcinoma
  • In cases of distant metastasis discovered during operation, only abdominal exploration or palliative surgery were adopt.
  • Uncontrolled seizures, central nervous system diseases or mental disorders
  • Uncorrectable coagulation dysfunction
  • Severe uncontrolled recurrent infections or other severe uncontrolled concomitant diseases
  • Diseases requiring immunosuppressive treatment, such as organ transplantation, SLE, etc
  • Other diseases requiring simultaneous surgery

About Xijing Hospital Of Digestive Diseases

Xijing Hospital of Digestive Diseases is a leading medical institution specializing in the diagnosis and treatment of gastrointestinal disorders. Affiliated with the Fourth Military Medical University in Xi'an, China, the hospital is renowned for its cutting-edge research and commitment to advancing digestive health. With a multidisciplinary team of experts, Xijing Hospital conducts innovative clinical trials aimed at improving patient outcomes and enhancing therapeutic strategies in digestive diseases. The institution is dedicated to fostering collaboration and excellence in clinical research, contributing significantly to the global understanding of gastrointestinal health and disease management.

Locations

Xi'an, Shaanxi, China

Patients applied

0 patients applied

Trial Officials

xiaohua li, MD,PH.D

Study Chair

Xijing Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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