Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula
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
1 other identifier
interventional
154
1 country
1
Brief Summary
Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic capsule injury, laparoscopic instrument clamp and long-term compression of pancreas, etc. TissePatchTM is a synthetic, self-adhesive, absorbable surgical sealant and barrier used to seal and reinforce wounds and prevent leakage of air, blood, and fluid during neurosurgery, spine, chest, and soft tissue surgery. Therefore, we proposed whether the use of TissuePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissuePatchTM on the prevention of pancreatic fistula after radical gastrectomy of gastric cancer can provide new clinical data for the prevention of pancreatic fistula after gastric cancer surgery, and help reduce a series of adverse reactions caused by pancreatic fistula in patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2022
CompletedFirst Posted
Study publicly available on registry
June 3, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedMay 8, 2024
May 1, 2024
2.7 years
May 30, 2022
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of pancreatic fistula after radical gastrectomy
Postoperative pancreatic fistula, in which any measurable volume of fluid is delivered through a surgically placed drainage tube, has amylase activity greater than 3 times the upper limit of normal plasma value
3 days
Secondary Outcomes (6)
the postoperative mortality
30 days
length of postoperative hospital stay
Up to 30 days
Classification of pancreatic fistula
3 days
number of lymph nodes dissection
1 days
incidence of postoperative complications
30 days
- +1 more secondary outcomes
Study Arms (2)
The experimental group
EXPERIMENTALRadical gastrectomy +D2 lymphadenectomy +TissuePatchTM to seal pancreatic tissue surface
The control group
OTHERRadical gastrectomy +D2 lymphadenectomy
Interventions
Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface
Radical gastrectomy +D2 lymphadenectomy
Eligibility Criteria
You may qualify if:
- 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)
- years old
- No incurable factors such as cancer cell metastasis in other organs
- Written informed consent signed voluntarily
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, 710032, China
Related Publications (1)
Yue C, Mo Z, Yang Q, Yu P, Zhou H, Gao R, Wang W, Guo Z, Zhang C, Wang Y, Ji P, Wu X, Zhang Y, Ji G, Li X. Comparison of the efficacy of TissuePatch versus no TissuePatch to seal pancreatic tissue surface for the prevention of pancreatic fistula after radical gastrectomy: study protocol for a prospective, single-center, randomized controlled trial. Trials. 2025 Dec 28. doi: 10.1186/s13063-025-09144-7. Online ahead of print.
PMID: 41456003DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
xiaohua li, MD,PH.D
Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate chief physician
Study Record Dates
First Submitted
May 30, 2022
First Posted
June 3, 2022
Study Start
August 1, 2022
Primary Completion
April 1, 2025
Study Completion
April 1, 2026
Last Updated
May 8, 2024
Record last verified: 2024-05