NCT02800772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

June 11, 2016

Last Update Submit

November 14, 2017

Conditions

Pancreatic Duct Cannulation During Endoscopic Retrograde Choledochopancreatography

Keywords

pancreatic ductERCPacetic acid

Outcome Measures

Primary Outcomes (2)

  • cannulation time for deep pancreatic duct cannulation

    2 days

  • fluoroscopy time for deep pancreatic duct cannulation

    2 days

Secondary Outcomes (2)

  • pancreatic juice flow from the major papilla

    2 days

  • appearance of the major papillary orifice

    2 days

Study Arms (2)

acetic acid

EXPERIMENTAL

spray 50ml acetic acid to duodenal bulb

Dietary Supplement: acetic acid

saline

PLACEBO COMPARATOR

spray 50ml saline to duodenal bulb

Dietary Supplement: saline

Interventions

acetic acidDIETARY_SUPPLEMENT
acetic acid
salineDIETARY_SUPPLEMENT
saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

  • 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.

    PMID: 29633339DERIVED

MeSH Terms

Interventions

Acetic AcidSodium Chloride

Intervention Hierarchy (Ancestors)

AcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Digestive Endoscopy Center

Study Record Dates

First Submitted

June 11, 2016

First Posted

June 15, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

CN(1)