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

103 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Somatostatin Analogues for pancreatic disease?

Somatostatin analogues have shown effectiveness in controlling tumor growth in neuroendocrine tumors of pancreatic origin and have been used to treat pancreatic fistulas. Preliminary studies also suggest some clinical activity in advanced pancreatic cancer, with improvements in pain and performance in certain patients. ^{1 2 3 4 5}

Is somatostatin analogue therapy safe for humans?

Somatostatin analogues, like octreotide, have been used in various studies and are generally considered safe for humans. They have been shown to reduce complications after pancreatic surgery and in the treatment of acute pancreatitis, although their effect on mortality rates is still uncertain. Adverse events have been reported, but the overall safety profile is favorable in the context of these conditions. ^{3 6 7 8 9}

How is the drug somatostatin analogues unique in treating pancreatic disease?

Somatostatin analogues are unique because they mimic a natural hormone to help control symptoms and slow tumor growth in pancreatic diseases, offering a longer-lasting effect compared to natural somatostatin. They are particularly used for managing neuroendocrine tumors and pancreatic fistulas, where other treatments have limited effectiveness. ^{1 2 3 4 10}

What is the purpose of this trial?

Researchers are trying to determine how the length of antibiotic treatment in addition to octreotide after pancreatic surgery affects the amount of time subjects are hospitalized as well as how many subjects develop pancreatic fistulas.

Research Team

Michael L Kendrick, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland 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. [2013]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Pancreatic cancer: does octreotide offer any promise? [2017]

3. England pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of somatostatin analogues for the treatment of pancreatic fistula. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Somatostatin analogs in oncology]. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of advanced pancreatic carcinoma with the somatostatin analogue BIM 23014. Preliminary results of a pilot study. [2019]

6. Greece pubmed.ncbi.nlm.nih.gov

Conservative treatment of acute pancreatitis: the use of somatostatin. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Antiproliferative effect of somatostatin analogs in advanced gastro-entero-pancreatic neuroendocrine tumors: a systematic review and meta-analysis. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Role of unlabelled somatostatin analogues in the prevention of complications after elective pancreatic and peripancreatic surgery: a critical review. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Prophylaxis of complications after pancreatic surgery: results of a multicenter trial in Italy. Italian Study Group. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Unlabelled somatostatin analogues in treatment of digestive endocrine tumours. [2019]