This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of octreotide microspheres in preventing pancreatic fistula after distal pancreatectomy.
This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of octreotide microspheres in preventing pancreatic fistula after distal pancreatectomy. Participants will be enrolled and allocated, with approximately 230 individuals expected to participate in this study conducted across three different medical institutions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
230
Octreotide Microspheres: 30mg, intramuscular injection, administered 7 days before surgery
Control group: Placebo (normal saline), administered 7 days before surgery.
Incidence of CR-POPF at 60 days postoperatively
Incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) at 60 days postoperatively (according to the 2016 International Study Group on Pancreatic Surgery \[ISGPS\] criteria).
Time frame: up to 60 days
Incidence of biochemical leak
Incidence of biochemical leak at 60 days postoperatively(according to the 2016 ISGPS criteria).
Time frame: up to 60 days
Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively
Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively (according to the 2022 Guidelines for Prevention and Management of Common Post-pancreatectomy Complications).
Time frame: up to 60 days
Mortality rate at 60 days postoperatively
Time frame: up to 60 days
Proportion of patients requiring rescue therapy
Time frame: up to 60 days
Length of hospital stay
Time frame: up to 60 days
Incidence and grading of adverse events (AEs) (NCI-CTCAE v5.0).
Time frame: up to 60 days
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