A Prospective Cohort Study on Ligation of Pancreatic Stump After Distal Pancreatectomy
NCT ID: NCT06814249
Last Updated: 2025-02-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ENROLLING_BY_INVITATION
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-11-21
Study Completion Date
2025-10-31
Brief Summary
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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.
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.
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Detailed Description
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Introduction The closure of pancreatic stump after distal pancreatectomy remains controversial. Currently, the main methods of pancreatic stump closure include manual suturing and stapler closure. However, both methods carry a high risk of pancreatic fistula, which may be associated with the difficulty of balancing the provision of sufficient pancreatic duct burst pressure and ensuring blood supply to the stump. Through in vitro experiments, we demonstrated that applying quantified ligation forces to pancreatic stumps can provide a pancreatic duct burst pressure of approximately 50-70 mmHg. This burst pressure is higher than the upper limit of normal pancreatic duct pressure and lower than the normal mean arterial pressure, theoretically balancing the pancreatic duct burst pressure and stump blood supply. Therefore, we designed this prospective cohort study to verify the above hypothesis.
Methods and analysis This is a prospective cohort study at single centre in China. The major eligibility criterion is the presence of lesions planned for distal pancreatectomy. The texture of the pancreas was determined by the surgeon and the first assistant during the operation as soft, medium, or hard. After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force. Postoperative regular follow-up will be performed. The primary outcomes included pancreatic fistula and postoperative hospital stay, and the secondary outcomes included intra-abdominal infection, incision infection, and postoperative treatment costs. The primary outcomes and secondary outcomes of patients in this cohort will be statistically compared with historical data using appropriate tests.
Ethics and dissemination The study has been approved by the Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology(2024-0833-02). The results of the study will be published in an international peer-reviewed journal.
Methods and analysis This is a prospective cohort study at single centre in China. The major eligibility criterion is the presence of lesions planned for distal pancreatectomy. The texture of the pancreas was determined by the surgeon and the first assistant during the operation as soft, medium, or hard. After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force. Postoperative regular follow-up will be performed. The primary outcomes included pancreatic fistula and postoperative hospital stay, and the secondary outcomes included intra-abdominal infection, incision infection, and postoperative treatment costs. The primary outcomes and secondary outcomes of patients in this cohort will be statistically compared with historical data using appropriate tests.
Ethics and dissemination The study has been approved by the Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology(2024-0833-02). The results of the study will be published in an international peer-reviewed journal.
Conditions
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Distal Pancreatectomy
Postoperative Pancreatic Fistula
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Experimental group
After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force.
Group Type
EXPERIMENTAL
ligation of pancreatic stump with a quantified force
Intervention Type
OTHER
After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force.
Control group
Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).
Group Type
ACTIVE_COMPARATOR
Manual suturing or stapling closure.
Intervention Type
OTHER
Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).
Interventions
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ligation of pancreatic stump with a quantified force
After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force.
Intervention Type
OTHER
Manual suturing or stapling closure.
Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Shanmiao Gou, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, HUST, Wuhan, China
Locations
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Uion Hospital, Tongji Medical College, HUST
Wuhan, Hubei, China
Site Status
Countries
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China
References
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Other Identifiers
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PS-PF
Identifier Type: -
Identifier Source: org_study_id
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