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
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.
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