Aspiration of Duodenopancreatic Juice After Secretin Stimulation vs Endoscopic Aspiration for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia.

What Was Tested

In this phase 3 trial, researchers set out to test Secretin for pancreatitis (after the acute phase).

Study to evaluate aspiration of duodenopancreatic juice after secretin stimulation (ADPJ-secr)versus endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for molecular analysis of intraductal papillary mucinous intraductal neoplasia.

It had two arms (groups): Duodenopancreatic aspiration after secretin stimulation + EUS-FNA (experimental) and EUS-FNA + duodenopancreatic aspiration after secretin stimulation (experimental).

Duodenopancreatic aspiration after secretin stimulation will be performed followed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA).

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) will be performed followed by duodenopancreatic aspiration after secretin stimulation.

The registry classes the interventions as drug and procedure.

Who Took Part

140 planned participants were the target.

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: Be a man or woman over 18 years of age. Willing to comply with the study procedures described in the protocol. Willing and able to give written informed consent. Meet at least one of the following three criteria in relation to the diagnosis or prognosis of IPMN:. IPMN with indication for surgical resection of the lesion.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: history of acute pancreatitis during the 30 days prior to inclusion; pregnant women, women who may become pregnant during the month prior to inclusion or women who are breastfeeding; known hypersensitivity to any component of the chirhostim® (human secretin) formulation.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Secretin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Secretin and the comparison at some point, usually with a gap in between.

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.

It started in 2023-09-13 with completion listed for 2025-01.

It ran at 1 site in Spain.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Proportion of patients with IPMN with GNAS and KRAS mutations in intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques (time frame: Through study completion, an average of 30 months).

It also tracked 46 secondary outcomes, for example Proportion of patients with IPMN with Tp53 mutations, DNA concentration expressed in ng/µl, Proportion of suitable samples obtained by the two techniques under study (ADPJ-secr and EUS-FNA) for molecular analysis, Proportion of patients undergoing pancreatic resection with a pathological diagnosis of IPMN who have mutations in GNAS and/or KRAS, Proportion of patients undergoing pancreatic resection without a pathological diagnosis of IPMN who do not have GNAS and/or KRAS mutations and Proportion of patients undergoing pancreatic resection with Tp53 mutations.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Secretin in 140 people with pancreatitis (after the acute phase).

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Secretin compound page, Pancreatitis (after the acute phase) research.