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NCT05404256
Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula
NA trial testing Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface in Pancreatic Fistula in 154 participants. Currently enrolling.
1 April 2025
Quick facts
| Lead sponsor | Xijing Hospital of Digestive Diseases |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 154 |
| Start date | 1 August 2022 |
| Primary completion | 1 April 2025 |
| Estimated completion | 1 April 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface
- Radical gastrectomy +D2 lymphadenectomy
Conditions studied
- Pancreatic Fistula — all drugs for Pancreatic Fistula →
Sponsor
Xijing Hospital of Digestive Diseases
Who can join
Adults 18 to 75, any sex, with Pancreatic Fistula. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Yue C, Mo Z, Yang Q, Yu P, et al · · 2025 · PMID 41456003 · DOI 10.1186/s13063-025-09144-7
Verify or expand the search:
- PubMed search for NCT05404256
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Xijing Hospital of Digestive Diseases trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05404256 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital of Digestive Diseases
- Last refreshed: 8 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05404256.
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