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Somatostatin Analogues

Somatostatin Analogue Therapy for Pancreatic Disease

Phase 2 & 3
Waitlist Available
Led By Michael L Kendrick, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients > 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during operative time plus 2 to 5 days post op
Awards & highlights

Study Summary

This trial is testing different lengths of antibiotic treatment and octreotide after pancreatic surgery to see how it affects hospital stay and pancreatic fistula development.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, somatostatin analogs typically may cause nausea, abdominal pain, gallstones, and changes in blood sugar levels. Antibiotics might lead to digestive issues or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during operative time plus 2 to 5 days post op
This trial's timeline: 3 weeks for screening, Varies for treatment, and during operative time plus 2 to 5 days post op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
This study aims to determine whether duration of antibiotic therapy coupled with octreotide leads to reduction of the severity or occurrence of pancreatic fistula.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group 1Active Control1 Intervention
Active somatostatin analogue combined with perioperative antibiotics
Group II: Group 2Placebo Group1 Intervention
Placebo combined with perioperative antibiotics

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,683 Total Patients Enrolled
Michael L Kendrick, MDPrincipal InvestigatorMayo Clinic

Media Library

Somatostatin Analogues (Somatostatin Analogues) Clinical Trial Eligibility Overview. Trial Name: NCT04329039 — Phase 2 & 3
Pancreatic Disease Research Study Groups: Group 1, Group 2
Pancreatic Disease Clinical Trial 2023: Somatostatin Analogues Highlights & Side Effects. Trial Name: NCT04329039 — Phase 2 & 3
Somatostatin Analogues (Somatostatin Analogues) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04329039 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being accepted for this experiment?

"According to the clinicaltrials.gov website, this study is no longer recruiting patients. While this specific trial is not enrolling candidates anymore, there are 22 other clinical trials presently searching for patients right now."

Answered by AI

What does Group 1's medication usually address?

"Biliary fistula patients are typically treated with Group 1 medication. This group of drugs is also effective at managing other disorders like restrictions of secretions, fistula, biliary, and acromegaly."

Answered by AI

Could you please compare and contrast Group 1's results with other research groups?

"Currently, there are six ongoing trials for Group 1. Of those, four are in Phase 3. The majority of the trial sites are in Boston, but Massachusetts has a total of twelve locations running these trials."

Answered by AI

Have medical professionals attempted something like this before?

"Group 1 has been under research since 2015 when the first clinical trial, involving 20 patients, was sponsored by Pharmbio Korea Co., Ltd. Since the original study, there have been 6 more trials in 2 cities and 3 countries which has led to Group 1's Phase 3 drug approval."

Answered by AI

How many patients are a part of this clinical trial?

"This study is no longer recruiting patients. This trial was first posted on July 16th, 2019 and was last updated on April 21st, 2022. There are currently 16 other trials involving pancreatic diseases that are recruiting and 6 trials in Group 1 that have open enrollment."

Answered by AI
~131 spots leftby Dec 2025