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Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas
Plain-language guide to NCT01301222: phase 4 randomized trial of Octreotide, pancreatitis (after the acute phase), 110 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01301222
- Phase
- phase 4
- Status
- completed
- Start
- 2010-09
- Completion (planned or actual)
- 2014-09
- Participants
- 110 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Pancreatic Fistula
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Octreotide for pancreatitis (after the acute phase).
This randomized controlled trial (RCT) aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas.
Soft pancreas and normal sized duct are the risk factors for fistula following PD.
It had 1 arm (groups): octreotide (experimental).
The registry classes the interventions as drug.
More on the Plan
Study design: Prospective open labeled randomized trial.
AIM: Study aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas.
Who Took Part
Enrollment: 110 actual participants took part.
It was open to people of any sex aged from 25 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Soft pancreas, no dilated duct.
The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: age \> 75 years old; documented chronic pancreatitis; previous pancreatic surgery.
How the Study Was Run
It was run as a randomized, single-group and open-label study.
Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2010-09 with completion listed for 2014-09.
It ran at 1 site in India.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Pancreatic fistula (time frame: 30 days).
It also tracked 1 secondary outcome, for example complications.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Octreotide in 110 people with pancreatitis (after the acute phase).
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Octreotide compound page, Pancreatitis (after the acute phase) research.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
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.