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

JRCT ID: jRCT1030210378

Registered date:19/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Normal pancreatic cases undergoing pancreaticoduodenectomy
• Date of first enrollment: 19/10/2021
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Drain amylase level on the third postoperative day

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Oda Tatsuya