NCT03263481

Brief Summary

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 our 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. Enrollment goal is 36 subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

6 years

First QC Date

August 23, 2017

Last Update Submit

September 20, 2023

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Outcome Measures

Primary Outcomes (12)

  • Secretory flow rates measured by volume

    Volume of pancreatic juices will be collected

    5 minutes

  • Secretory flow rates measured by volume

    Volume of pancreatic juices will be collected

    10 minutes

  • Secretory flow rates measured by volume

    Volume of pancreatic juices will be collected

    15 minutes

  • Secretory flow rates measured by volume

    Volume of pancreatic juices will be collected

    20 minutes

  • Secretory flow rates measured by volume

    Volume of pancreatic juices will be collected

    25 minutes

  • Secretory flow rates measured by volume

    Volume of pancreatic juices will be collected

    30 minutes

  • Bicarbonate concentration of timed pancreatic juice

    Concentration of bicarbonate levels will be determined

    5 minutes

  • Bicarbonate concentration of timed pancreatic juice

    Concentration of bicarbonate levels will be determined

    10 minutes

  • Bicarbonate concentration of timed pancreatic juice

    Concentration of bicarbonate levels will be determined

    15 minutes

  • Bicarbonate concentration of timed pancreatic juice

    Concentration of bicarbonate levels will be determined

    20 minutes

  • Bicarbonate concentration of timed pancreatic juice

    Concentration of bicarbonate levels will be determined

    25 minutes

  • Bicarbonate concentration of timed pancreatic juice

    Concentration of bicarbonate levels will be determined

    30 minutes

Study Arms (1)

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.

Procedure: Intraductal secretin test (IDST)

Interventions

Intraductal secretin test (IDST)PROCEDURE

If pancreatic duct entry incidentally occurs during the clinically scheduled ERCP and the pancreatic duct appears normal, an IDST will be performed for study purposes. An IDST consists of the administration of human secretin, after which pancreatic juice is collected intraductally. In this study, the fluid will be collected through continuous aspiration in 5 minute intervals for 30 minutes. Samples will be collected at 5, 10, 15, 20, 25, and 30 minutes after secretin administration (6 collections in total).

ERCP with inadvertent pancreatic cannulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Pregnant woman or breast feeding
  • Age \<18 years
  • Patient unable to give informed consent
  • Patient with a history of pancreatic surgery
  • Patient with a history of pancreatic cancer
  • Patient with a history of acute or chronic pancreatitis
  • Patient with radiographic evidence of acute or chronic pancreatitis on CT, MRCP, or EUS
  • Patient with a current or prior history of average daily alcohol consumption of greater than 60 g per day for more than 2 years
  • Patient with a history of cigarette smoking greater that 20 pack-years
  • Patient with a history of pancreas divisum
  • Evidence of chronic pancreatitis on pancreatogram during ERCP
  • ERCP for an isolated biliary indication with previous biliary sphincterotomy or for biliary stent exchange, when pancreatic entry should easily be avoided by the endoscopist.
  • History of allergy or adverse reactions to secretin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Study Officials

  • Evan L Fogel, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 28, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

US(1)