Comparison of Three-sided and Single-sided Mattress Pancreaticojejunostomy in Pancreatoduodenectomy

NCT06855888 | Enrolling By Invitation

• 2 other identifiers: 24R128UMIN000056623
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In pancreaticojejunostomy following pancreaticoduodenectomy for soft pancreas, a randomized controlled trial will be conducted to compare a patient group using the conventional Blumgart modified technique and a patient group in which mattress sutures are added to the cranial and caudal sides of the pancreaticojejunostomy after the Blumgart modified technique (three-sided mattress suture technique), and to evaluate the safety and usefulness of the three-sided mattress suture technique by comparing the incidence of pancreatic fistula (ISGPF grade B or C).

Conditions

Postoperative Pancreatic Fistula Post-pancreatoduodenectomy

Keywords

mattress suture; pancreaticojejunostomy; pancreatoduodenectomy; postoperative pancreatic fistula

Outcome Measures

Primary Outcomes (1)

• Incidence of pancreatic fistula ISGPF grade B or C

  Up to 90 days after surgery

Secondary Outcomes (1)

• Incidence of postoperative complications, incidence of remnant pancreatitis

  Up to 90 days after surgery

Study Arms (2)

Group A: Modified Blumgart suture method (conventional treatment group)

PLACEBO COMPARATOR

Procedure: Modified Blumgart suture method

Group B: Three-sided mattress suture (test treatment group)

ACTIVE COMPARATOR

Procedure: Three-sided mattress suture

Interventions

Modified Blumgart suture method PROCEDURE

During pancreaticoduodenectomy, the modified Blumgart suture method is used for pancreaticojejunostomy. For anastomosis, 5-0PDS is used for pancreatic duct mucosal anastomosis, and 3-0 or 4-0 monofilament non-absorbable suture is used for pancreaticojejunal mattress anastomosis.

Group A: Modified Blumgart suture method (conventional treatment group)

Three-sided mattress suture PROCEDURE

At the time of pancreaticoduodenectomy, the three-sided mattress suture is used as the pancreaticojejunostomy method. In addition to the conventional Blumgart modified suture, the three-sided mattress suture method adds a mattress anastomosis with 3-0 or 4-0 monofilament non-absorbable suture to the cranial and caudal sides of the pancreaticojejunostomy site.

Group B: Three-sided mattress suture (test treatment group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for pancreaticoduodenectomy who have been determined to have a soft pancreas.
• Preoperative CT images show that the pancreatic duct diameter at the planned site of pancreatic resection is 5mm or less.
• ECOG Performance Status (PS) is 0-1.
• Age 18 years or older.
• Function of major organs (bone marrow, heart, liver, kidneys, lungs, etc.) is maintained.
• Patients have sufficient judgment to understand the content of the research, and written consent has been obtained from the individual.

You may not qualify if:

• Patients with severe ischemic heart disease
• Patients with liver cirrhosis or active hepatitis
• Patients with respiratory distress requiring oxygen due to interstitial pneumonia or pulmonary fibrosis
• Patients undergoing dialysis due to chronic renal failure
• Patients requiring combined resection of surrounding organs
• Patients requiring arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc.
• Patients with active duplicate cancers that may affect adverse events or overall survival
• Patients taking oral steroids for a long period that may affect adverse events
• Patients with insufficient decision-making ability
• Other subjects deemed inappropriate by the principal investigator or investigator

Sponsors & Collaborators

• Tokai University: lead

Study Sites (1)

Tokai University

Isehara-shi, Kanagawa, 259-1193, Japan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Once PD is performed, there is no difference in postoperative radiographic findings between the two surgical approaches, so it should not affect the radiologist's assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 4, 2025
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

JP (1)