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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

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.

Condition or disease Intervention/treatment Phase
Pancreatic Duct Cannulation During Endoscopic Retrograde Choledochopancreatography Dietary Supplement: acetic acid Dietary Supplement: saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : June 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: acetic acid
spray 50ml acetic acid to duodenal bulb
Dietary Supplement: acetic acid
Placebo Comparator: saline
spray 50ml saline to duodenal bulb
Dietary Supplement: saline



Primary Outcome Measures :
  1. cannulation time for deep pancreatic duct cannulation [ Time Frame: 2 days ]
  2. fluoroscopy time for deep pancreatic duct cannulation [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. pancreatic juice flow from the major papilla [ Time Frame: 2 days ]
  2. appearance of the major papillary orifice [ Time Frame: 2 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800772


Locations
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China, Shanghai
Changhai Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhaoshen Li, Digestive Endoscopy Center, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02800772    
Other Study ID Numbers: ERCP-01
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Zhaoshen Li, Changhai Hospital:
pancreatic duct
ERCP
acetic acid
Additional relevant MeSH terms:
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Acetic Acid
Retinol acetate
Anti-Bacterial Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents