- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02800772
Impact of Intraduodenal Acetic Acid Infusion on Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Double-blind, Randomized Controlled Trial
November 14, 2017 updated by: Zhaoshen Li, Changhai Hospital
Intraduodenal acetic acid can stimulate secretion of water and bicarbonate from pancreatic ductal cells.
In this study, acetic acid spraying to duodenal bulb was compared with saline solution for the facilitation of pancreatic duct cannulation in patients.The primary outcome was successful deep pancreatic duct cannulation.
The secondary outcomes were the appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct cannulation in the acetic acid group versus saline group.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Changhai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inclusion criteria were(1)those with intact native papilla (2)who underwent endoscopic retrograde choledochopancreatography for pancreatic duct, (3)age≥18 years,≦80years,and (4)agreement to participate in the study.
Exclusion Criteria:
- Exclusion criteria were (1) a previous sphincterotomy, (2) previous attempted or unsuccessful endoscopic retrograde choledochopancreatography with papillary manipulation, (3) indwelling biliary or pancreatic stent(s), (4) active acute pancreatitis, (5) altered/postsurgical anatomy, (6) history of gastroparesis, and (7) endoscopic retrograde choledochopancreatography for sphincter of Oddi (SO) manometry.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: acetic acid
spray 50ml acetic acid to duodenal bulb
|
|
Placebo Comparator: saline
spray 50ml saline to duodenal bulb
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cannulation time for deep pancreatic duct cannulation
Time Frame: 2 days
|
2 days
|
fluoroscopy time for deep pancreatic duct cannulation
Time Frame: 2 days
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
appearance of the major papillary orifice
Time Frame: 2 days
|
2 days
|
pancreatic juice flow from the major papilla
Time Frame: 2 days
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
June 11, 2016
First Submitted That Met QC Criteria
June 11, 2016
First Posted (Estimate)
June 15, 2016
Study Record Updates
Last Update Posted (Actual)
November 17, 2017
Last Update Submitted That Met QC Criteria
November 14, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERCP-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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