NCT03937037

Brief Summary

In this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

May 1, 2019

Last Update Submit

January 20, 2023

Conditions

Stone - Biliary

Keywords

ERCPCommon bile duct stoneCholangitisResidual stoneIrrigationRecurrence

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Recurrence of CBD Stones

    Number of Participants with stones detected by Magnetic resonance cholangiopancreatography, CT or US confirms CBD stone recurrence no matter symptomatic choledocholithiasis or not

    3 years

Secondary Outcomes (5)

  • Number of Participants with Cholangitis

    3 years

  • Number of Participants with Pancreatitis

    3 years

  • Number of Participants with Bleeding

    1 month

  • Number of Participants with Perforation

    1 month

  • Procedure time of each case

    7 days

Study Arms (2)

Saline irrigation

EXPERIMENTAL

CBD stone removal after routine ERCP procedure,100ml saline irrigation after a balloon occlusion cholangiogram confirming the absence of stones.

Procedure: Saline irrigation

None saline irrigation

NO INTERVENTION

CBD stone removal after routine ERCP procedure, a balloon occlusion cholangiogram confirms the absence of stones.

Interventions

Saline irrigationPROCEDURE

100ml saline irrigation after CBD stone removal with routine ERCP procedure

Saline irrigation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With ERCP indications
  • With mechanical lithotripsy during operation

You may not qualify if:

  • Unwillingness or inability to consent for the study
  • Unstable vital signs
  • Coagulation dysfunction (INR\>1.5) and low peripheral blood platelet count (\<50×10 \^9 / L) or using anti-coagulation drugs
  • Prior surgery of Bismuth Ⅱ, Roux-en-Y and cholangiojejunostomy
  • Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock
  • Biliary-duodenal fistula confirmed during ERCP
  • Pregnant women or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Related Publications (3)

  • Ahn DW, Lee SH, Paik WH, Song BJ, Park JM, Kim J, Jeong JB, Hwang JH, Ryu JK, Kim YT. Effects of Saline Irrigation of the Bile Duct to Reduce the Rate of Residual Common Bile Duct Stones: A Multicenter, Prospective, Randomized Study. Am J Gastroenterol. 2018 Apr;113(4):548-555. doi: 10.1038/ajg.2018.21. Epub 2018 Mar 27.

    PMID: 29610513BACKGROUND

  • Ang TL, Teo EK, Fock KM, Lyn Tan JY. Are there roles for intraductal US and saline solution irrigation in ensuring complete clearance of common bile duct stones? Gastrointest Endosc. 2009 Jun;69(7):1276-81. doi: 10.1016/j.gie.2008.10.018. Epub 2009 Feb 26.

    PMID: 19249039BACKGROUND

  • Lin Y, Yang M, Cao J, Zhang X, Mi N, Yang X, Wang H, Gao L, Bai M, Fu W, Li X, Yue P, Yuan J, Meng W, Leung JW. Saline irrigation for reducing the recurrence of common bile duct stones after lithotripsy: a randomized controlled trial. EClinicalMedicine. 2023 Apr 27;59:101978. doi: 10.1016/j.eclinm.2023.101978. eCollection 2023 May.

    PMID: 37152367DERIVED

MeSH Terms

Conditions

CholecystolithiasisGallstonesCholangitisRecurrence

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBile Duct DiseasesDisease AttributesPathologic Processes

Study Officials

  • Wenbo Meng, MD,PhD

    Hepatopancreatobiliary Surgery Institute of Gansu Province

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph. D, Direct of surgery

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 3, 2019

Study Start

May 10, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)