Pancreatic Fistula
Conditions
Keywords
Pancreatic Fistula, Octreotide Microspheres, Distal Pancreatectomy
Brief summary
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.
Detailed description
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.
Interventions
Octreotide Microspheres: 30mg, intramuscular injection, administered 7 days before surgery
DRUGPlacebo
Control group: Placebo (normal saline), administered 7 days before surgery.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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; * Female subjects of childbearing potential must agree to use reliable methods of contraception from the time of signing the informed consent form until at least 120 days after administration of the study drug. A negative HCG test result within 7 days prior to initiating study treatment is required, and they must not be lactating; * Male subjects with partners of childbearing potential must agree to use reliable methods of contraception from the time of signing the informed consent form until at least 120 days after administration of the study drug; during the same period, male patients must also agree not to donate sperm.
Exclusion criteria
* 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; * International Normalized Ratio (INR) \>1.5, or use of medication affecting prothrombin time (PT) or activated partial thromboplastin time (APTT); * Patients scheduled for total pancreatectomy; * History of pancreatic resection surgery; * Concurrent severe cardiac, pulmonary, hepatic, or renal disease making the patient unfit for surgery; * Previous treatment with long-acting somatostatin analogues; treatment with somatostatin or short-acting somatostatin analogues within 5 half-lives; * Known allergy to somatostatin or its analogues; * Current participation in another clinical trial, except for observational, non-interventional studies or the follow-up period of an interventional study; * Any condition that, in the investigator's judgment, may pose a risk to the subject from receiving the study drug, or may interfere with the evaluation of the study drug, subject safety, or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CR-POPF at 60 days postoperatively | up to 60 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of biochemical leak | up to 60 days | Incidence of biochemical leak at 60 days postoperatively(according to the 2016 ISGPS criteria). |
| Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively | up to 60 days | 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). |
| Mortality rate at 60 days postoperatively | up to 60 days | — |
| Proportion of patients requiring rescue therapy | up to 60 days | — |
| Length of hospital stay | up to 60 days | — |
| Incidence and grading of adverse events (AEs) (NCI-CTCAE v5.0). | up to 60 days | — |
Contacts
CONTACTWenquan Wang
Outcome results
None listed