Patients who undergo distal pancreatectomy
Conditions
Interventions
Reinforced stapler + Clip on Staple method
Reinforced stapler
Sponsors
Kyushu Study group of Clinical Cancer (KSCC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Elective distal pancreatectomy(open/laparoscopic/laparoscope-assisted/robot assisted) for disease of the pancreatic body and tail. *Spleen-preserving DP, RAMPS, DP with combined resection of surrounding organs(e.g. DP-CAR) are also included. 2)The thickness of the pancreatic cutting line on preoperative images are equal or less than 20mm. 3)ECOG Performance Status is 0-1. 4)Aged 20 years old or older. 5)Function of the major organs are maintained. 6)Following criteria are fulfilled in the recent laboratory tests within 30 days from registration. A)White Blood Cells >= 2,500/mm3 B)Haemoglobin levels >= 9.0 g/dL C)Platelet counts >= 100,000/mm3 D)Albumin levels >= 3.0 g/dL E)Total Bilirubin levels <= 2.0 mg/dL F)Creatinine levels <= 2.0 mg/dL 7)Sufficient understanding of the study to provide written informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of clinically-relevant pancreatic fistula(ISGPF GradeB/C) or death due to any cause within 30 days after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| <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) | — |
Countries
Japan
Contacts
Public ContactMizuki Ninomiya
Fukuoka City Hospital Department of Liver Surgery
Outcome results
None listed