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Intraductal Secretin Stimulation Test: What Is the Proper Collection Time?

Plain-language guide to NCT03263481: not phased interventional trial of Secretin, 8 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03263481
Phase
not phased
Status
completed
Start
2017-09-01
Completion (planned or actual)
2023-09-01
Participants
8 (actual)
Design
na, open label (everyone knows who gets what), basic_science
Conditions studied
Cholangiopancreatography, Endoscopic Retrograde
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Secretin.

The aim is to evaluate the peak secretory flow rates and bicarbonate concentrations as determined by a 30 minute intraductal secretin stimulation test in patients with a low likelihood of pancreatic pathology and to compare these data to those obtained from their historical patients with suspected chronic pancreatitis.

These will be patients in which inadvertent pancreatic cannulation occurs during therapeutic endoscopic retrograde cholangiopancreatography (ERCP) for biliary indications .

All study subjects will receive a 5 day follow-up phone call.

It had 1 arm (groups): ERCP with inadvertent pancreatic cannulation (experimental).

Subjects undergoing ERCP for a biliary indication in which inadvertent pancreatic cannulation occurs will undergo intraductal secretin testing per the study protocol.

The registry classes the interventions as procedure.

Who Took Part

The registry lists 8 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.

The full record lists 0 inclusion and 13 exclusion criteria; among the exclusions: pregnant woman or breast feeding; age \<18 years; patient unable to give informed consent.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Secretin 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 2017-09-01 with completion listed for 2023-09-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Secretory flow rates measured by volume (time frame: 5 minutes). Secretory flow rates measured by volume (time frame: 10 minutes). Secretory flow rates measured by volume (time frame: 15 minutes).

What This Means in Plain Language

Put simply, this is a not phased trial of Secretin in 8 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Secretin compound page, all human trials.

Our Notes on the Compound

Secretin: A 27-amino-acid gut hormone that triggers pancreatic secretion; used as a diagnostic agent in pancreatic function testing.

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.