A Prospective Cohort Study on Ligation of Pancreatic Stump After Distal Pancreatectomy

NCT06814249 | Enrolling By Invitation DMC

• 1 other identifier: PS-PF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if igation of pancreatic stump with quantified force works in decrease postoperative pancreatic fistula following distal pancreatectomy. The main outcome measures are: Postoperative pancreatic fistula; Postoperative hospital stay. Researchers will compare ligation to other pancreatic stump closure techniques to see if it decrease postoperative pancreatic fistula and postoperative hospital stay following distal pancreatectomy.

Conditions

Distal Pancreatectomy; Postoperative Pancreatic Fistula

Keywords

Pancreatic surgery; Distal pancreatectomy; Pancreatic texture; Pancreatic stump ligation; Postoperative pancreatic fistula

Outcome Measures

Primary Outcomes (2)

• Pancreatic fistula

  Postoperative pancreatic fistula adopts the definition proposed by the International Study Group of Pancreatic Surgery.

  Up to half a year from enrollment

• Postoperative hospital stay

  Stay from operation to discharge.

  Up to half a year from enrollment

Secondary Outcomes (3)

• Intra-abdominal infection

  Up to half a year from enrollment

• Incision infection

  Up to half a year from enrollment

• Postoperative treatment costs

  Up to half a year from enrollment

Study Arms (2)

Experimental group

EXPERIMENTAL

After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force.

Other: ligation of pancreatic stump with a quantified force

Control group

ACTIVE COMPARATOR

Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).

Other: Manual suturing or stapling closure.

Interventions

ligation of pancreatic stump with a quantified force OTHER

After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force.

Experimental group

Manual suturing or stapling closure. OTHER

Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients fully understand this study, voluntarily participate, and sign the Informed Consent Form (ICF);
• Age between 18 and 75 years old;
• Planned for distal pancreatectomy (including body and tail of the pancreas);
• The intended pancreatic transection line is located on the left side of the portal vein.

You may not qualify if:

• History of previous pancreatic surgery;
• Additional surgical procedures required for the residual pancreas;
• Proximal pancreatic duct obstruction, with planned anastomosis between the residual pancreas and the digestive tract;
• Use of long-acting somatostatin analogues during the perioperative period;
• Patients who are judged by the investigator to be unsuitable for participation in this study.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Uion Hospital, Tongji Medical College, HUST

Wuhan, Hubei, 430022, China

Location

Related Publications (23)

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Study Officials

• Shanmiao Gou, MD, Ph.D

  Union Hospital, HUST, Wuhan, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: February 7, 2025
• Study Start: November 21, 2024
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: February 26, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)