Skip to main content
OpenTrials
Completed

NCT Number: NCT02800772

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Duct Cannulation During Endoscopic Retrograde Choledochopancreatography

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acetic acid

Dietary Supplement

Saline

Dietary Supplement

Primary outcomes

  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 outcomes

  1. pancreatic juice flow from the major papilla

    Time frame: 2 days

  2. appearance of the major papillary orifice

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2016
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.