NIPH Clinical Trials Search

JRCT ID: jRCT1030210378

Registered date:19/10/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedNormal pancreatic cases undergoing pancreaticoduodenectomy
Date of first enrollment19/10/2021
Target sample size50
Countries of recruitment
Study typeInterventional
Intervention(s)Intervention for pancreaticojejunostomy in pancreaticoduodenectomy. *Refer to the attached research plan.


Primary OutcomeDrain amylase level on the third postoperative day
Secondary OutcomeSafety 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.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 85age old
Include criteriaAge: 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.
Exclude criteriaPatients 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

Related Information


Public contact
Name Shinji Hashimoto
Address 1-1-1, tennoudai,Tsukuba,Ibaraki Ibaraki Japan 305-8575
Telephone +81-298533221
Affiliation University of Tsukuba
Scientific contact
Name Tatsuya Oda
Address 1-1-1, tennoudai,Tsukuba,Ibaraki Ibaraki Japan 305-8575
Telephone +81-298533221
Affiliation University of Tukuba