NCT03701009

Brief Summary

The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

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

October 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

October 6, 2018

Last Update Submit

July 12, 2020

Conditions

Stone Clearance

Keywords

ERCPCommon bile duct stoneCholangitisResidual stoneIrrigation

Outcome Measures

Primary Outcomes (1)

  • Stone fragments clearance

    Type 1: Not clean, large stone fragments; Type 2: Clusters residue and floccule; Type 3: Small biliary sludge or floccule Type 4: Slightly clean with a small amount of floccule or small residue; Type 5: Clean.

    3 months

Secondary Outcomes (5)

  • Post-ERCP cholangitis

    3 months

  • Bleeding

    3 months

  • Post-ERCP pancreatitis

    3 months

  • Perforation

    3 months

  • The procedure time

    3 months

Study Arms (1)

Stone removal (Saline 50ml each time)

OTHER

After CBD stone removal via lithotripsy, and the cholangiogram showed normal, residual CBD stones were detected by SpyGlass in the first round, if CBD not clean, sterile saline 50ml were intermittently irrigated into the CBD. After that, if bile duct clearance was not achieved, another 50ml saline will be irrigated into CBD again until the clear bile duct determined by SpyGlass.

Procedure: CBD stone removal via lithotripsyProcedure: Saline 50mlProcedure: Saline +50ml

Interventions

CBD stone removal via lithotripsyPROCEDURE

Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.

Stone removal (Saline 50ml each time)
Saline +50mlPROCEDURE

If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance.

Stone removal (Saline 50ml each time)

Eligibility Criteria

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

You may qualify if:

  • ERCP common bile duct stone patients were able to provide written informed consent;
  • Size of stone large than 1.2 cm.

You may not qualify if:

  • Unwillingness or inability to consent for the study;
  • Coagulation dysfunction (INR\> 1.5) and low peripheral blood platelet count (\<50×10\^9 / L) or using anti-coagulation drugs;
  • Previous ERCP;
  • Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy;
  • Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, 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;
  • Presence of intrahepatic duct stone;
  • Malignancy.

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 (2)

  • 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

  • Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7.

    PMID: 21737076BACKGROUND

MeSH Terms

Conditions

GallstonesCholangitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBile Duct Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Xun Li, MD,PhD

    Hepatopancreatobiliary Surgery Institute of Gansu Province

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2018

First Posted

October 9, 2018

Study Start

October 10, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)