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

NCT ID: NCT02800772

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-10-31

Brief Summary

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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

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Conditions

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Pancreatic Duct Cannulation During Endoscopic Retrograde Choledochopancreatography

Keywords

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pancreatic duct ERCP acetic acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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acetic acid

spray 50ml acetic acid to duodenal bulb

Group Type EXPERIMENTAL

acetic acid

Intervention Type DIETARY_SUPPLEMENT

saline

spray 50ml saline to duodenal bulb

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DIETARY_SUPPLEMENT

Interventions

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acetic acid

Intervention Type DIETARY_SUPPLEMENT

saline

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Digestive Endoscopy Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 29633339 (View on PubMed)

Other Identifiers

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ERCP-01

Identifier Type: -

Identifier Source: org_study_id