Octreotide Microspheres for Preventing Pancreatic Fistula
ConditionPancreatic Fistula
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Subjects voluntarily participate in this study and sign the informed consent form;
Age ≥18 and ≤80 years old, both males and females are eligible;
Preoperative imaging assessment indicates the corresponding disease is surgically resectable;
Planned to undergo distal pancreatectomy;
Disqualifiers
Cirrhosis or chronic active hepatitis;
Presence of malabsorption syndrome, short bowel syndrome, or choleretic diarrhea that cannot be effectively controlled;
Acute cholecystitis;
Uncontrolled infection, or history of immunodeficiency, including a positive HIV test;
Trial design
Treatments tested in this trial
- Octreotide Microspheres
- Placebo
Treatment groups
230 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov