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A Phase II Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
Plain-language guide to NCT03174353: phase 2 interventional trial of Lanreotide, 114 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03174353
- Phase
- phase 2
- Status
- completed
- Start
- 2018-02-20
- Completion (planned or actual)
- 2021-02-01
- Participants
- 114 (actual)
- Design
- na, open label (everyone knows who gets what), prevention
- Conditions studied
- Pancreatic Leak; Pancreatic Fistula; Pancreaticoduodenal; Fistula; Pancreatectomy; Hyperglycemia
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Lanreotide.
Following this intervention, care will be based on standard treatment protocols.
It had 1 arm (groups): Lanreotide arm (experimental).
The registry classes the interventions as drug.
More on the Plan
Assessment for pancreatic and non-pancreatic complications will be made at the time of discharge and in follow-up by the attending surgeon.
Patients will be evaluated in clinic postoperatively within 21 days of discharge for evaluation of the primary endpoint.
The research team will perform long term follow-up by phone or in person with patients at 30 and 60 days (+/- 10 days at each time point).
SCREENING AND ENROLLMENT Subjects undergoing planned elective pancreaticoduodenectomy or distal pancreatectomy for malignancy or suspected malignancy will be identified and screened for eligibility.
Who Took Part
The registry lists 114 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female patients age ≥ 18 years. Candidate for planned elective pancreaticoduodenectomy or distal pancreatectomy for malignancy or suspected malignancy. Able to provide informed consent.
The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: use of disallowed concomitant medications; planned tumor enucleation or total pancreatectomy; pregnancy or breastfeeding.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Lanreotide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2018-02-20 with completion listed for 2021-02-01.
It ran at 1 site in United States.
Its stated primary purpose is prevention.
What Was Measured
It also tracked 2 secondary outcomes, for example Biochemical Leak (Grade A Postoperative Pancreatic Fistula) and Overall Postoperative Morbidity.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Lanreotide in 114 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Lanreotide compound page, all human trials.
Our Notes on the Compound
Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.