Greater Omentum Binding to the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

Study Overview
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Brief Summary
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Background and aim: Distal pancreatectomy (DP) is often performed for primary benign or malignant lesions occurred in the body or tail of the pancreas. The occurrence of pancreatic fistula (PF) after DP remains high, ranging from 5% to 60%, despite in high-volume centers. Management of pancreatic stump to prevent PF has been a long-standing issue in pancreatic surgery. Our group has proposed greater omentum binding as a novel approach to secure pancreatic stump with the purpose of reducing PF. With respect to the previous preliminary data which demonstrated greater omentum binding of pancreatic stump significantly reduced the occurrence of PF based on a small prospective cohort, we therefore aimed to verify the safety and effectiveness of this novel approach in a large prospective randomized cohort. Method: TJBDPS06 is a prospective, randomized controlled, parallel-group, superiority trial in a single high-volume pancreatic center. A total of 200 patients who will receive DP and fulfill the inclusion criteria will be randomly allocated to the greater omentum binding group or the group without this step in an enhanced recovery after surgery (ERAS) setting. The trial hypothesize that greater omentum binding of pancreatic stump could safely and effectively secure pancreatic stump following DP, therefore reducing the occurrence of PF. The primary outcome is PF within 90 days after DP. The secondary outcomes are overall morbidly, mortality, and major complications (Clavien-Dindo ≥III) within 90 days following DP. The duration of entire trial is presumably three years, including prearrangement, two-year inclusion period, and data analysis. Discussion: The current trial will be the first in demonstrating safety and effectiveness of greater omentum binding of pancreatic stump following DP in a large high-volume pancreatic center. This approach will offer an inexpensive, technically easy, and secure coverage technique for the pancreatic stump in DP and may be particularly useful for patients with a soft pancreas which is a markedly risk factor of PF.

Official Title
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Intra-operative Greater Omentum Binding to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy: A Randomized Clinical Trial

Conditions
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Pancreatic Fistula, Pancreatic Neoplasms

Intervention / Treatment
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* Procedure: greater omentum binding
* Procedure: Pancreatic stump exposed without omentum binding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who undergo DP whether made by open or laparoscopic surgery; Patients age 18 to 75 years; Patients benefit from distal pancreatectomy according to NCCN guidelines; The subject understands the nature of this trial and willing to comply, and ability to provide written informed consent. Exclusion Criteria: Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs; History of abdominal disease or surgery which may results in obvious omentum adhesion; Synchronous malignancy in other organs; Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4; Pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Greater omentum binding<br>Bind greater omentum to pancreatic stump after distal pancreatectomy | Procedure: greater omentum binding<br>* Bind pancreatic stump using greater omentum after distal pancreatectomy<br>|
| Experimental: Pancreatic stump exposed<br>pancreatic stump exposed without binding greater omentum after distal pancreatectomy | Procedure: Pancreatic stump exposed without omentum binding<br>* Pancreatic stump exposed without greater omentum binding after distal pancreatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pancreatic fistula | Incidence of pancreatic fistula defined by ISGPF classification | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall morbidity | Incidence of any type of postoperative morbidity after distal pancreatectomy | 90 days | 
| mortality | Incidence of patients deceased after distal pancreatectomy within follow-up period | 90 days | 
| major complications (Clavien-Dindo ≥III) | Incidence of major complications defined as a complication with Clavien-Dindo score ≥III | 90 days |