Clinical trial · Interventional
A Prospective, Multi-center Trial for Reinforced Staple During Distal Pancreatectomy
A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During Distal Pancreatectomy
NCT02270554CI-TRIAL-00023188completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endo GIA Reinforced Reload with Tri-Staple technology | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Reinforced staple
- description
- Endo GIA Reinforced Reload with Tri-Staple technology
- interventionNames
- Device: Endo GIA Reinforced Reload with Tri-Staple technology
Primary outcomes (1)
- measure
- Incidence of pancreatic fistula grade B/C
- timeFrame
- Ninety days after operation
Secondary outcomes (12)
- measure
- Incidence of pancreatic fistula defined by ISGPF classification
- timeFrame
- Ninety days after operation
- measure
- Incidence of pancreatic fistula grade C defined by ISGPF classification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. disease of pancreatic body and tail 2. PS (ECOG Performance Status Scale)0-1 3. Age: 20 years or older 4. distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis 5. Patients who can provide written informed consent Exclusion Criteria: 1. Patients with severe ischemic cardiac disease 2. Patients with severe liver cirrhosis or active hepatitis 3. Patients with respiratory illness that requires oxygen administration 4. Patients with chronic renal failure requiring dialysis 5. Patients requiring other organ resection 6. Patients who are unfit for the study as determined by the attending physician
References
Publications (1)
- DERIVEDKawai M, Hirono S, Okada KI, Satoi S, Yanagimoto H, Kon M, Murakami Y, Kondo N, Sho M, Akahori T, Toyama H, Fukumoto T, Fujii T, Matsumoto I, Eguchi H, Ikoma H, Takeda Y, Fujimoto J, Yamaue H. Reinforced staplers for distal pancreatectomy. Langenbecks Arch Surg. 2017 Dec;402(8):1197-1204. doi: 10.1007/s00423-017-1634-1. Epub 2017 Nov 4. PMID 29103084