Polyglycolic acid felt reinforcement of the pancreaticojejunostomy; Japan-Korea Multicenter prospective randomized phase III trial -PLANET-PJ trial

Not Applicable

• Conditions: Patients who are scheduled to undergo pancreatoduodenectomy for disease of pancreatic or periampullary lesions

• Registration Number: JPRN-UMIN000029647
• Lead Sponsor: Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-30
• Study Completion: 2022-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 514

Inclusion Criteria

Not provided

Exclusion Criteria

1)Planned pancreatogastrostomy 2)Laparoscopic or laparoscope-assisted pancreatoduodenectomy 3)Pancreatic parenchymal atrophy or calcification due to chronic pancreatitis 4)Neoadjuvant treatment including chemotherapy or radiotherapy 5)History of upper abdominal surgery (both of open and laparoscopic) except cholecystectomy 6)Emergency operation 7)Arterial reconstruction such as superior mesenteric artery, common hepatic artery, or celiac artery 8)Severe ischemic heart disease 9)Severe liver dysfunction due to liver cirrhosis or active hepatitis 10)Severe respiratory disorder required oxygen inhalation 11)Chronic renal failure with dialysis 12)Requiring resection of other organs (liver or colon) during pancreatoduodenectomy 13)Immunosuppressive treatment 14)History of severe hypersensitivity to PGA mesh and fibrin glue 15)Other severe drug allergies 16)Contrast media allergy of both iodine and gadolinium 17)Active duplicate cancer thought to affect adverse events 18)Severe psychological or neurological disease 19)Drug abuse or alcoholics 20)Planned use of octreotide

Study & Design

• Study Type: Interventional
• Study Design: Not specified