Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Intraduodenal Acetic Acid Infusion on Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Double-blind, Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800772
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Tracking Information
First Submitted Date  ICMJE June 11, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date November 17, 2017
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2016)
  • cannulation time for deep pancreatic duct cannulation [ Time Frame: 2 days ]
  • fluoroscopy time for deep pancreatic duct cannulation [ Time Frame: 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2016)
  • pancreatic juice flow from the major papilla [ Time Frame: 2 days ]
  • appearance of the major papillary orifice [ Time Frame: 2 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Intraduodenal Acetic Acid Infusion on Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Double-blind, Randomized Controlled Trial
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Duct Cannulation During Endoscopic Retrograde Choledochopancreatography
Intervention  ICMJE
  • Dietary Supplement: acetic acid
  • Dietary Supplement: saline
Study Arms  ICMJE
  • Experimental: acetic acid
    spray 50ml acetic acid to duodenal bulb
    Intervention: Dietary Supplement: acetic acid
  • Placebo Comparator: saline
    spray 50ml saline to duodenal bulb
    Intervention: Dietary Supplement: saline
Publications * Fang J, Wang SL, Zhao SB, Hu LH, Yao J, Shen Z, Gu L, Xia T, Cai Q, Li ZS, Bai Y. Impact of intraduodenal acetic acid infusion on pancreatic duct cannulation during endoscopic retrograde cholangiopancreatography: A double-blind, randomized controlled trial. J Gastroenterol Hepatol. 2018 Oct;33(10):1804-1810. doi: 10.1111/jgh.14148. Epub 2018 May 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2017)
210
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2016)
200
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800772
Other Study ID Numbers  ICMJE ERCP-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhaoshen Li, Changhai Hospital
Study Sponsor  ICMJE Changhai Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Changhai Hospital
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP