Greater Omentum Binding To The Pancreatic Stump To Prevent Pancreatic Fistula Following Distal Pancreatectomy

Study Overview

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

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.

N/A

Pancreatic Fistula
Pancreatic Neoplasms

PROCEDURE: greater omentum binding
PROCEDURE: Pancreatic stump exposed without omentum binding

TJDBPS06

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-11-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-11-21
First Submitted that Met QC Criteria 2018-11-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-11-23
First Posted (ACTUAL) 2018-11-23	Results First Posted N/A	Last Verified 2018-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

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

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

Primary Outcome Measures	Measure Description	Time Frame
pancreatic fistula	Incidence of pancreatic fistula defined by ISGPF classification	90 days

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Junfang Zhao

Phone Number: +8615827539076

Email: zhaojunfang2012@hotmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Renyi Qin, MD, PhD, Department of Biliary and Pancreatic Surgery, Tongji Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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