Neoplasms

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Fistula

Pancreatic Fistula

Pathological Conditions, Anatomical

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

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Pancreatic Cancer

Bind greater omentum to pancreatic stump after distal pancreatectomy

pancreatic stump exposed without binding greater omentum after distal pancreatectomy

Bind pancreatic stump using greater omentum after distal pancreatectomy

greater omentum binding

Pancreatic stump exposed without greater omentum binding after distal pancreatectomy

Pancreatic stump exposed without omentum binding

Junfang Zhao

Junfang O Zhao, MD, PhD

Renyi Qin, MD, PhD

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.

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

Incidence of pancreatic fistula defined by ISGPF classification

Incidence of any type of postoperative morbidity after distal pancreatectomy

Incidence of patients deceased after distal pancreatectomy within follow-up period

Incidence of major complications defined as a complication with Clavien-Dindo score ≥III

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Greater Omentum Binding to the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy	NCT03752086	Pancreatic Fist... Pancreatic Neop...	greater omentum... Pancreatic stum...	18 Years - 75 Years	Tongji Hospital
Greater Omentum Binding to the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy	NCT03752086	Pancreatic Fist... Pancreatic Neop...	greater omentum... Pancreatic stum...	18 Years - 75 Years	Tongji Hospital

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