An exploratory randomized controlled trial comparing a novel IIDH method of pancreaticoduodenectomy with the conventional Blumgart method to demonstrate the efficacy of the concept

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1030210378

Enrollment

Registered

2021-10-19

Start date

2021-10-19

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

Normal pancreatic cases undergoing pancreaticoduodenectomy pancreaticojejunostomy, pancrearic fistula Grade (ISGPF)

Interventions

Intervention for pancreaticojejunostomy in pancreaticoduodenectomy. *Refer to the attached research plan.

Clavien Dindo Grade, pancreatic fistula Grade(ISGPF), pancreaticojejunostomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age: 20 to 85 years old at the time of obtaining consent ASA-PS (American Society of Anesthesiologists physical status): 3 or less Determination of soft pancreas: Soft pancreas is defined as the main pancreatic duct diameter of 4 mm or less or intraductal papillary mucous-producing tumor on preoperative imaging. Patients who have obtained written consent of their own free will after receiving sufficient explanation and understanding for participation in this study.

Exclusion criteria

Exclusion criteria: Patients with severe ischemic heart disease Patients with liver cirrhosis of Child B or higher or active hepatitis Patients with respiratory distress requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis Patients undergoing dialysis for chronic renal failure Cases requiring resection of other organs BMI of more than 30 Other cases judged to be unsuitable by the physician in charge

Design outcomes

Primary

Measure	Time frame
Drain amylase level on the third postoperative day	—

Secondary

Measure	Time frame
Safety endpoints: Clavien-Dindo Grade, ISGPF POPF Grade. Risk factors: height and weight, BMI, gender, age, ASA-PS, previous medical conditions, pancreatic duct diameter and parenchyma thickness (preoperative images) Surgical factors: operative time, blood loss, time required for pancreatic jejunal anastomosis, years of experience as a surgeon. Postoperative factors: extracorporeal drainage amylase/lipase levels, blood amylase/lipase levels at 1, 3, 5, and 7 days after surgery. Blood test data (white blood cell, hemoglobin, platelet, total bilirubin, CRP). Pancreatic juice drainage during hospitalization (maximum value), volume of pancreatic juice drainage during hospitalization (maximum value), duration of drainage.	—

Measure

Time frame

Safety endpoints: Clavien-Dindo Grade, ISGPF POPF Grade. Risk factors: height and weight, BMI, gender, age, ASA-PS, previous medical conditions, pancreatic duct diameter and parenchyma thickness (preoperative images) Surgical factors: operative time, blood loss, time required for pancreatic jejunal anastomosis, years of experience as a surgeon. Postoperative factors: extracorporeal drainage amylase/lipase levels, blood amylase/lipase levels at 1, 3, 5, and 7 days after surgery. Blood test data (white blood cell, hemoglobin, platelet, total bilirubin, CRP). Pancreatic juice drainage during hospitalization (maximum value), volume of pancreatic juice drainage during hospitalization (maximum value), duration of drainage.

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Contacts

Public ContactShinji Hashimoto

University of Tsukuba

shinji-H@md.tsukuba.ac.jp+81-298533221

Outcome results

None listed

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