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Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula

NCT05404256 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-05-08

No results posted yet for this study

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.

Conditions

  • Pancreatic Fistula

Interventions

OTHER

Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface

Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface

OTHER

Radical gastrectomy +D2 lymphadenectomy

Radical gastrectomy +D2 lymphadenectomy

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Principal Investigators

  • xiaohua li, MD,PH.D · Xijing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-04-01
Completion
2026-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05404256 on ClinicalTrials.gov