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

NCT03752086 | Unknown DMC

• 1 other identifier: TJDBPS06
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Fistula; Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• pancreatic fistula

  Incidence of pancreatic fistula defined by ISGPF classification

  90 days

Secondary Outcomes (3)

• overall morbidity

  90 days

• mortality

  90 days

• major complications (Clavien-Dindo ≥III)

  90 days

Study Arms (2)

Greater omentum binding

EXPERIMENTAL

Bind greater omentum to pancreatic stump after distal pancreatectomy

Procedure: greater omentum binding

Pancreatic stump exposed

EXPERIMENTAL

pancreatic stump exposed without binding greater omentum after distal pancreatectomy

Procedure: Pancreatic stump exposed without omentum binding

Interventions

greater omentum binding PROCEDURE

Bind pancreatic stump using greater omentum after distal pancreatectomy

Greater omentum binding

Pancreatic stump exposed without omentum binding PROCEDURE

Pancreatic stump exposed without greater omentum binding after distal pancreatectomy

Pancreatic stump exposed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Pancreatic Fistula; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Officials

• Renyi Qin, MD, PhD

  Department of Biliary and Pancreatic Surgery, Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junfang Zhao

CONTACT

+8615827539076; zhaojunfang2012@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief physician

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 23, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 23, 2018

Record last verified: 2018-11

Locations

CN (1)