Clinical trial NCT06814249: A Prospective Cohort Study on Ligation of Pancreatic Stump After Distal Pancreatectomy
Official title: A Prospective Cohort Study on Ligation of Pancreatic Stump With Quantified Force During Distal Pancreatectomy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Distal Pancreatectomy
Postoperative Pancreatic Fistula
Keywords: Pancreatic surgery
Distal pancreatectomy
Pancreatic texture
Pancreatic stump ligation
Postoperative pancreatic fistula
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Pancreatic fistula
timeFrame: Up to half a year from enrollment
measure: Postoperative hospital stay
timeFrame: Up to half a year from enrollment
Secondary outcomes:
measure: Intra-abdominal infection
timeFrame: Up to half a year from enrollment
measure: Incision infection
timeFrame: Up to half a year from enrollment
measure: Postoperative treatment costs
timeFrame: Up to half a year from enrollment
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Uion Hospital, Tongji Medical College, HUST
state: Hubei
Study officials:
affiliation: Union Hospital, HUST, Wuhan, China
name: Shanmiao Gou, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
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