Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Octreotide Microspheres

    Drug

    Octreotide Microspheres: 30mg, intramuscular injection, administered 7 days before surgery

  • Placebo

    Drug

    Control group: Placebo (normal saline), administered 7 days before surgery.

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: Octreotide MicrospheresExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Incidence of biochemical leak

Incidence of biochemical leak at 60 days postoperatively(according to the 2016 ISGPS criteria).

Time frame
up to 60 days
2

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
3

Mortality rate at 60 days postoperatively

Time frame
up to 60 days
4

Proportion of patients requiring rescue therapy

Time frame
up to 60 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: