Pancreatic FistulaPhase 3NCT07479784
Octreotide Microspheres for Preventing Pancreatic Fistula
A Phase 3 study testing Octreotide Microspheres in people with Pancreatic Fistula, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Octreotide Microspheres
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of Octreotide Microspheres for 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.
Read the 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.
- Conditions
- Pancreatic Fistula
- Being tested
- Octreotide Microspheres, Placebo
- Keywords
- Pancreatic Fistula, Octreotide Microspheres, Distal Pancreatectomy
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide MicrospheresDrug
Octreotide Microspheres: 30mg, intramuscular injection, administered 7 days before surgery
PlaceboDrug
Control group: Placebo (normal saline), administered 7 days before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Octreotide Microspheres | Experimental | Octreotide microspheres (Youyuan), 30 mg, intramuscular injection; administered 7 days before surgery. Receives: Drug: Octreotide Microspheres |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 60 days
Secondary outcomes (6)
Incidence of biochemical leak
Incidence of biochemical leak at 60 days postoperatively(according to the 2016 ISGPS criteria).
Measured: 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).
Measured: up to 60 days
Mortality rate at 60 days postoperatively
Measured: up to 60 days
Proportion of patients requiring rescue therapy
Measured: up to 60 days
Length of hospital stay
Measured: up to 60 days
Incidence and grading of adverse events (AEs) (NCI-CTCAE v5.0).
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479784
- Sponsor's protocol ID
- B2026-051R
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of Octreotide Microspheres for Preventing Pancreatic Fistula After Distal Pancreatectomy
- ClinicalTrials.gov ID
- NCT07479784
- Acronym / sponsor ID
- B2026-051R
- Conditions
- Pancreatic Fistula
- Keywords
- Pancreatic Fistula, Octreotide Microspheres, Distal Pancreatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octreotide Microspheres | Experimental | Drug: Octreotide MicrospheresOctreotide microspheres (Youyuan), 30 mg, intramuscular injection; administered 7 days before surgery. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide MicrospheresOctreotide Microspheres: 30mg, intramuscular injection, administered 7 days before surgery | Drug | Octreotide Microspheres |
| PlaceboControl group: Placebo (normal saline), administered 7 days before surgery. | Drug | Placebo |
Primary outcome
Incidence of CR-POPF at 60 days postoperatively
Time frame: 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).
6 secondary outcomes
Incidence of biochemical leak
Time frame: up to 60 days
Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octreotide Microspheres in people with Pancreatic Fistula, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenquan Wang (+86 21 31587861, wang.wenquan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CR-POPF at 60 days postoperatively (time frame: up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.