ClinicalTrials.Veeva

Menu

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

N

Naval Military Medical University

Status

Completed

Conditions

Pancreatic Duct Cannulation During Endoscopic Retrograde Choledochopancreatography

Treatments

Dietary Supplement: saline
Dietary Supplement: acetic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT02800772
ERCP-01

Details and patient eligibility

About

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.

Enrollment

210 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

210 participants in 2 patient groups, including a placebo group

acetic acid
Experimental group
Description:
spray 50ml acetic acid to duodenal bulb
Treatment:
Dietary Supplement: acetic acid
saline
Placebo Comparator group
Description:
spray 50ml saline to duodenal bulb
Treatment:
Dietary Supplement: saline

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems