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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Neoplasms; Pancreatic Fistula
• Intervention / Treatment: Procedure: greater omentum binding; Procedure: Pancreatic stump exposed without omentum binding

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junfang Zhao; Phone Number: +8615827539076; Email: zhaojunfang2012@hotmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Greater omentum binding; Bind greater omentum to pancreatic stump after distal pancreatectomy	Procedure: greater omentum binding; Bind pancreatic stump using greater omentum after distal pancreatectomy
Experimental: Pancreatic stump exposed; pancreatic stump exposed without binding greater omentum after distal pancreatectomy	Procedure: Pancreatic stump exposed without omentum binding; Pancreatic stump exposed without greater omentum binding after distal pancreatectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Renyi Qin, MD, PhD, Department of Biliary and Pancreatic Surgery, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Neoplasms; Pancreatic Fistula
• Other Study ID Numbers: TJDBPS06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No