An interventional study of ligation of pancreatic stump with a quantified force and Manual suturing or stapling closure. in Distal Pancreatectomy and Postoperative Pancreatic Fistula, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Prevention
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.
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.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 172 studies on the registry; 136 are open to participants now.
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Exclusion Criteria:
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
Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).
Other: Manual suturing or stapling closure.
After severing the pancreas, the pancreas was ligated at 5 mm from the pancreatic stump with a quantified force.
Handle the pancreatic stump according to conventional methods (manual suturing or stapling closure).
Pancreatic fistula
Postoperative pancreatic fistula adopts the definition proposed by the International Study Group of Pancreatic Surgery.
Time frame: Up to half a year from enrollment
Postoperative hospital stay
Stay from operation to discharge.
Time frame: Up to half a year from enrollment
Intra-abdominal infection
Intra-abdominal infection is evaluated based on Common Terminology Criteria for Adverse Event (CTCAE) V.5.0.
Time frame: Up to half a year from enrollment
Incision infection
Incision infection is evaluated based on Common Terminology Criteria for Adverse Event (CTCAE) V.5.0.
Time frame: Up to half a year from enrollment
Postoperative treatment costs
Treatment costs of postoperative period.
Time frame: Up to half a year from enrollment
Plan to share: No
Started Nov 2024 (actual). Primary completion is estimated for Sep 2025, 10 months after the start.
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