Pancreatic body/tail region disease
Conditions
Interventions
Group A (control group):
Pancreatic transection is performed using a stapler with absorbable suture reinforcement. No other reinforcement of the pancreatic stump is performed.
Group B
Sponsors
Takahashi Yu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Laparoscopic or robot-assisted distal pancreatectomy. 2. Pancreatic transection using a stapler is planned. 3. Performance Status (PS) of ECOG is 0-1. 4. Age is 20 years or older. 5.The functions of major organs (bone marrow, liver, kidneys, lungs, etc.) are preserved. A)White blood cell count: 2,500/mm3 or more, 14,000/mm3 or less B)Hemoglobin content: 9.0g/dL or more C)Platelet count: 100,000/mm3 or more D)Total bilirubin: 2.0 mg/dL or less E)Creatinine: 2.0mg/dL or less 6. The applicant has sufficient judgment to understand the research content, and written consent has been obtained from the applicant.
Exclusion criteria
Exclusion criteria: 1. Case of open distal pancreatectomy 2. Cases in which pancreatic dissection is performed using a method other than a stapler 3. Cases with a history of upper abdominal surgery (open or laparoscopic) (both cholecystectomy are acceptable) 4. Emergency surgery case 5. Cases in which reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. is considered necessary. 6. Cases with serious ischemic heart disease 7. Cases complicated by liver cirrhosis or active hepatitis 8.Cases with breathing difficulties that require oxygen administration due to interstitial pneumonia, pulmonary fibrosis, etc. 9. Cases undergoing dialysis due to chronic renal failure 10. Cases requiring combined resection of surrounding organs such as the liver and large intestine 11. Cases receiving continuous systemic administration of steroids or immunosuppressants 12.Cases with a history of severe hypersensitivity to polyglycolic acid sheets or fibrin glue 13. Cases with severe drug allergy 14. Cases where iodine drugs cannot be used due to drug allergy 15.Active multiple cancers that are thought to affect adverse events 16. Cases scheduled for use of octreotide 17.Cases in which it is considered difficult to participate in the study due to psychosis or comorbid psychiatric symptoms 18.Drug or alcohol dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of clinically relevant pancreatic fistula (ISGPS grade B/C) | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative amylase levels of drain fluid, drain indwelling period, postoperative hospital stay, overall incidence of pancreatic fistula (Biochemical leak/Grade B/C), incidence of delayed gastric emptying, incidence of postoperative intra-abdominal abscess, incidence of postoperative intra-abdominal bleeding, rate of drain reinsertion, incidence of all postoperative complications, incidence of complications related to postoperative pancreatic fistula (total of pancreatic fistula, delayed gastric emptying, intra-abdominal abscess, and intra-abdominal bleeding), surgical mortality rate, reoperation rate, readmission rate, presence and volume of peripancreatic fluid accumulation on CT scans before drain removal and on the 90th postoperative day | — |
Contacts
Public ContactKosuke Kobayashi
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Outcome results
None listed