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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03752086
• Other study ID #: TJDBPS06
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: April 2021

Study information

• Verified date: November 2018
• Source: Tongji Hospital
• Contact: Junfang Zhao
• Phone: +8615827539076
• Email: zhaojunfang2012[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula
• Pancreatic Neoplasms

Intervention

Procedure:
• greater omentum binding
Bind pancreatic stump using greater omentum after distal pancreatectomy
• Pancreatic stump exposed without omentum binding
Pancreatic stump exposed without greater omentum binding after distal pancreatectomy

Locations

Country	Name	City	State
China	Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic fistula	Incidence of pancreatic fistula defined by ISGPF classification	90 days
Secondary	overall morbidity	Incidence of any type of postoperative morbidity after distal pancreatectomy	90 days
Secondary	mortality	Incidence of patients deceased after distal pancreatectomy within follow-up period	90 days
Secondary	major complications (Clavien-Dindo =III)	Incidence of major complications defined as a complication with Clavien-Dindo score =III	90 days