A Multicenter, single-blind, randomized, parallel-group trial comparing stapler closure with Clip on Staple method with stapler closure alone during Distal Pancreatectomy
Phase 2
Recruiting
- Conditions
- Patients who undergo distal pancreatectomy
- Registration Number
- JPRN-UMIN000042217
- Lead Sponsor
- Kyushu Study group of Clinical Cancer (KSCC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 188
Inclusion Criteria
Not provided
Exclusion Criteria
1)Superior mesenteric vein or portal vein invasion on preoperative images. 2)Planned cutting line of the pancreas is right side of the superior mesenteric vein or portal vein. 3)Use of stapling device is inappropriate. 4)Presence of inoperable factors such as peritoneal dissemination, invasion to major vessels, or liver metastases. 5)Emergent cases. 6)Severe cardiac diseases(NYHA>=3). 7)Need for daily oxygen supply due to severe pulmonary diseases. 8)On maintenance hemodialysis due to chronic renal failure. 9)Allergy to metals. 10)Considered as inappropriate by attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of clinically-relevant pancreatic fistula(ISGPF GradeB/C) or death due to any cause within 30 days after surgery.
- Secondary Outcome Measures
Name Time Method <Secondary endpoints> The incidence of following complications within 30 days after surgery. _Pancreatic fistula(ISGPF BL/GradeB/C) _Postpancreatectomy hemorrhage(PPH) _Intra-abdominal abscess _Delayed gastric emptying _Complications(Clavien-Dindo classification, CD>=Grade3) _Percutaneous or Endoscopic drainage Duration of drainage tube placement Postoperative hospital stay Operative time/Blood loss Re-operation within 90 days Mortality within 90 days <Exploratory endpoints> The incidence of clinically-relevant pancreatic fistula according to the thickness of the pancreas(<=12mm/>12mm) The incidence of pancreatic parenchymal injury after clipping(Central review of intraoperative photography)