Using TissuePatchTM to prevent pancreatic fistula after gastric cancer surgery
Randomized Controlled Trial for Comparison of the Effects of Preventing Postoperative Pancreatic Fistula by With Versus Without TissuePatchTM Cover the Wound Surface of Pancreatic Capsule
NA · Xijing Hospital of Digestive Diseases · NCT05404256
This study is testing if a new surgical sealant called TissuePatchTM can help prevent serious complications after surgery for gastric cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT05404256 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of TissuePatchTM, a synthetic surgical sealant, in preventing postoperative pancreatic fistula following radical gastrectomy for gastric cancer. The study aims to compare outcomes between patients receiving TissuePatchTM and those who do not, focusing on the incidence of pancreatic fistula, which is a serious complication that can arise during surgery. By enrolling patients with histologically confirmed gastric adenocarcinoma, the trial will gather clinical data to assess whether this innovative approach can reduce complications associated with gastric cancer surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with histologically confirmed gastric adenocarcinoma who are undergoing radical gastrectomy.
Not a fit: Patients with distant metastasis or those requiring pancreatic resection during surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of postoperative pancreatic fistula, improving recovery and survival rates for gastric cancer patients.
How similar studies have performed: While the use of surgical sealants is common in various surgical fields, the specific application of TissuePatchTM for preventing pancreatic fistula in gastric cancer surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Xi'an, Shaanxi
- Xijing Hospital of Digestive Disease — Xi'an, Shaanxi, China (RECRUITING)
Study contacts
- Study coordinator: xiaohua Li, MD,PH.D
- Email: xjyylixiaohua@163.com
- Phone: +8613474299901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Fistula, TissuePatchTM, radical gastrectomy, postoperative pancreatic fistula