WRAP study

JRCT ID: jRCTs032240120

Registered date:15/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic body/tail region disease
• Date of first enrollment: 17/06/2024
• Target sample size: 172
• Study type: Interventional

Intervention(s)

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 (intervention group):
Pancreatic transection is performed using a stapler with absorbable suture reinforcement. The pancreatic stump is covered with a PGA sheet and reinforced with fibrin glue.

Outcome(s)

• Primary Outcome: Incidence rate of clinically relevant pancreatic fistula (ISGPS grade B/C)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Takahashi Yu
• Source(s) of Monetary Support: GUNZE MEDICAL LIMITED,KM Biologics Co., Ltd.