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The safety and efficacy of stapler method for transection of the pancreatic parenchyma during pancreatoduodenectomy (STRAP-PD trial): study protocol for a randomized control trial

The safety and efficacy of stapler method for transection of the pancreatic parenchyma during pancreatoduodenectomy (STRAP-PD trial): study protocol for a randomized control trial - STRAPP-PD trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052089
Enrollment
160
Registered
2023-10-01
Start date
2023-09-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with soft pancreas were scheduled to undergo pancreaticoduodenectomy

Interventions

The pancreas was transected using a linear stapler. The pancreas was transected using a energy device.

Sponsors

Wakayama medical university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients judged to have soft pancreas among those scheduled for pancreaticoduodenectomy. 2) The thickness of the pancreatic parenchyma can be cut with surgical stapler. 3) ECOG Performance Status (PS) is 0-1. 4) Age 20 years or older. 5) The functions of major organs (bone marrow, heart, liver, kidneys, lungs, etc.) are maintained. 6) Sufficient judgment to understand the content of the research and providing written informed consent.

Exclusion criteria

Exclusion criteria: 1) Serious ischemic heart disease. 2) Complication of liver cirrhosis or active hepatitis. 3) Dyspnea requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis. 4) Undergoing dialysis for chronic renal failure. 5) Requiring combined resection of surrounding organs. 6) Considered to require arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. 7) Active double cancers that may affect adverse events or overall survival. 8) Long-term oral steroid use that may cause adverse events. 9) Psychosis or psychiatric symptoms judged to potentially cause difficulty in participation in the study. 10) History of abdominal operation including gastrectomy, colectomy, rectal resection, hepatectomy, but excluding cholecystectomy. 11) Inability to use both iodine-based drugs and gadolinium-based drugs due to serious drug allergies.

Design outcomes

Primary

MeasureTime frame
Rate of pancreatic fistula ISGPF grade B or C

Countries

Japan

Contacts

Public ContactManabu Kawai

Wakayama medical university 2nd department of surgery

kawai@wakayama-med.ac.jp0734410613

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026