Somatostatin Analogue Therapy for Pancreatic Disease

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Mayo Clinic

Disqualifiers: Negligible risk, Arterial resection, Pregnant

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: During operative time plus 2 to 5 days post op

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a somatostatin analogue (a drug that slows hormone production) combined with antibiotics after pancreatic surgery can reduce hospital stays and prevent pancreatic fistulas (leaks from the pancreas). The trial compares two groups: one receives the active drug, and the other receives a placebo, both with antibiotics. It seeks participants undergoing a Whipple procedure for specific pancreatic conditions and considered at intermediate to high risk. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that somatostatin analogues are likely to be safe for humans?

Research has shown that somatostatin analogues are generally safe to use after pancreatic surgery. Studies have found that they can help reduce complications like pancreatic fistulas, which are leaks from the pancreas that can occur after surgery. This indicates the treatment effectively prevents some common post-surgery problems.

Moreover, real-world studies have demonstrated that patients tolerate somatostatin analogues well. These studies have reported no major severe side effects, which is reassuring for those considering joining a trial. Overall, current evidence suggests the safety of somatostatin analogues is promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about somatostatin analogues for pancreatic disease because they offer a unique approach by mimicking the natural hormone somatostatin, which helps regulate various bodily functions, including the inhibition of pancreatic secretions. Unlike standard treatments like enzyme supplements and pain management drugs, somatostatin analogues directly target the underlying processes of pancreatic disease, potentially reducing symptoms and complications more effectively. This innovative mechanism of action could lead to improved outcomes for patients with pancreatic conditions, offering hope for a more efficient and targeted therapy.

What evidence suggests that somatostatin analogues might be an effective treatment for pancreatic disease?

Research shows that somatostatin analogues can help patients undergoing pancreatic surgery. In this trial, participants in Group 1 will receive an active somatostatin analogue combined with perioperative antibiotics. Studies indicate that these treatments significantly reduce the chance of developing pancreatic fistulas, a common complication, by about one-third. As a result, patients using these treatments are less likely to encounter this issue. They also lower the risk of sepsis, a serious infection, by more than half. Additionally, these treatments can lead to shorter hospital stays after surgery. Overall, somatostatin analogues offer promising benefits for reducing complications in pancreatic surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael L Kendrick, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having a Whipple procedure (a type of pancreatic surgery) due to various conditions like neuroendocrine tumors or adenocarcinoma. It's specifically for those at intermediate-high risk according to certain protocols. Pregnant individuals, low-risk patients, minors, and anyone needing arterial resection can't participate.

Inclusion Criteria

I am having a Whipple procedure and am considered intermediate-high risk.

I am older than 18 years.

Exclusion Criteria

Currently pregnant

I am under 18 years old.

Negligible and low risk patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive somatostatin analogues or placebo combined with perioperative antibiotics

During operative time plus 2 to 5 days post op

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Somatostatin Analogues

Trial Overview The study is examining the effectiveness of combining somatostatin analogues with short-term antibiotics versus just prolonged antibiotics after pancreatic surgery. The goal is to see if this affects hospital stay duration and the occurrence of pancreatic fistulas.

How Is the Trial Designed?

Group I: Group 1 Active Control 1 Intervention

Active somatostatin analogue combined with perioperative antibiotics

Group II: Group 2 Placebo Group 1 Intervention

Placebo combined with perioperative antibiotics

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 43 patients with pancreatic neuroendocrine tumors treated with octreotide, somatostatin analogues (SSA) demonstrated significant antiproliferative effects, with a median time to tumor progression of 13 months.

Patients with a lower proliferation index (Ki67 <10%) experienced a more durable response to treatment, suggesting that SSA can be an effective first-line therapy for managing metastatic pancreatic NET.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of octreotide long-acting release on tumour growth control as a first-line treatment in neuroendocrine tumours of pancreatic origin. Jann, H., Denecke, T., Koch, M., et al.[2013]

Somatostatin analogs (SSAs) significantly improve disease control in advanced gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs), with a hazard ratio of 0.41 indicating a strong reduction in disease progression compared to placebo in a meta-analysis of 289 patients.

While SSAs have a good safety profile overall, they are associated with a higher risk of biliary stones compared to placebo, highlighting the need for monitoring this specific adverse effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiproliferative effect of somatostatin analogs in advanced gastro-entero-pancreatic neuroendocrine tumors: a systematic review and meta-analysis. Merola, E., Panzuto, F., Delle Fave, G.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7175835/

Somatostatin analogues for pancreatic surgery - PMC Secondary outcomes​​ There were statistically significant lower incidences of pancreatic fistula (RR 0.66; 95% CI 0.55 to 0.79) and sepsis (RR 0.42; 95% CI 0.21 ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0331909

A Bayesian network meta-analysis | PLOS One In this meta-analysis, we observed significant differences in the efficacy of several somatostatin analogs in preventing postoperative pancreatic fistula (POPF) ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1365182X25000784

“Somatostatin analogues do not reduce the risk of clinically ... Twenty studies, including 6947 patients, were eligible for inclusion. Overall, SSA use did not significantly lower the risk of developing a POPF(OR 0.89, 95 % ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20590882/

Meta-analysis of randomized controlled trials on the ... Conclusions: Somatostatin analogues reduce perioperative complications but do not reduce perioperative mortality. However, they do shorten hospital stay in ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)43540-0/fulltext

Long-term clinical outcome of somatostatin analogues for ... Response rate after 6 months of treatment was 45.2% (all disease stabilisation: 27.8% of pancreatic vs. 81.8% of intestinal tumours, P = 0.007). The predictors ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0014299925008076

Real-world drug safety study of somatostatin analogs ... Additionally, they have shown promising results in managing pancreatitis, treating polycystic liver disease, and addressing severe secretory disorders ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40971392/

The influence of somatostatin analogues on the incidence ... The search focused on studies comparing the use of somatostatin analogs after pancreatic surgery. Key outcomes included postoperative pancreatic ...

8. journals.lww.com journals.lww.com/pancreasjournal/fulltext/2025/07000/somatostatin_analogs_versus_active_surveillance_in.4.aspx

Somatostatin Analogs Versus Active Surveillance in Small... The best strategy for nonfunctioning, sporadic, G1-G2 pancreatic neuroendocrine tumors ≤2 cm is unknown. An active surveillance is usually recommended.