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Status unknownNCT03442205Updated Mar 1, 2018

Treatment of Common Bile Duct Stones

An interventional study of LC + LCBDE + ENBD + primary closure of CBD and ERCP technique + LC in Common Bile Duct Stone, sponsored by Tongji Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 38 studies in Gallstones with a site in China — 7 open to participants now, 8 under way, none of them phase 3. Gallstones · China.

Planned enrollment
7th of 28
200 · median 145
Started
2018
with 2 others
No phase
22 of 38
7 open now
Registered
12th of 38
by date
Lead sponsor
2 of 38
Tongji Hospital

Among the 38 studies in Gallstones with a site in China, this one is the 7th largest by planned enrollment of the 28 interventional ones that give a count, is one of 3 that started in 2018, is one of 22 with no phase, and was the 12th registered.

Gallstones

200 studies on the registry are indexed under Gallstones; 36 are open to participants now.

Browse Gallstones studies →

Open to participants now

7 of the 38 studies in Gallstones with a site in China are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 24 Gallstones studies recruiting now, 11 (46%) set no upper age limit and 10 (42%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 38 studies in Gallstones with a site in China, or all of them as a file.
02

Study summary

ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation, especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for treatment. This study compares outcomes of different surgical procedures treating for the disease.

Methods/design: This is a prospective, randomized, controlled multicenter trial with three treatment arms. One group underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + intraoperative endoscopic nasobiliary drainage ENBD + primary closure of CBD. The other underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP) and subsequent LC and the third arm underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + primary closure of CBD. The duration of the entire trial is two years including prearrangement, follow-up and analyses.

Discussion: Despite the fact plenty evidences provided by meta-analyses suggests that these approaches would appear comparable. It is hopeful to fully address which would be the better approach with this RCT design.

03

Conditions studied

  • Common Bile Duct Stone

Browse trials for

Keywords

  • Common Bile Duct Stone;
  • Laparoscopic Common Bile Duct Exploration;
  • ERCP;
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with age between 18 - 80 years.
  • Patients diagnosed with gallstones.
  • Patients diagnosed with common bile duct stone by one of the three exam (US、MRCP and CT).
  • Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
  • Patients understood the trial and accepted one of the three managements.

Exclusion criteria

Exclusion Criteria:

  • Combined with Mirizzi syndrome and intrahepatic bile duct stones
  • Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)
  • History of upper abdominal surgery.
  • Serious heart, brain, lung, metabolic diseases history.
  • Pregnant women.
  • Unwillingness or inability to consent for the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Group A

    Procedure: LC + LCBDE + ENBD + primary closure of CBD

  • Experimental
    Group B

    Procedure: ERCP technique + LC

  • Experimental
    Group C

    Procedure: LC + LCBDE + primary closure of CBD

Interventions

  • ProcedureLC + LCBDE + ENBD + primary closure of CBD

    LC + LCBDE + ENBD + primary closure of CBD

  • ProcedureERCP technique + LC

    ERCP technique + LC

  • ProcedureLC + LCBDE + primary closure of CBD

    LC + LCBDE + primary closure of CBD

06

What researchers measure

Primary outcomes

  1. Rate of Adverse outcomes

    The patients developing complications/ the total patients

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Tongji Hospital
    Wuhan, Hubei 430000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2018; primary completion for Mar 2020, 24 months later.

Of 58 non-industry interventional studies with no phase under Gallstones, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 24 months is above that.

Counting every sponsor, half of 58 studies reached it within 20 months; a quarter within 12 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2018
First posted
Feb 22, 2018
StartEst.
Mar 1, 2018
Primary completionEst.
Mar 1, 2020
CompletionEst.
Mar 1, 2021
Last update
Mar 1, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03442205
Lead sponsor
Tongji Hospital
Responsible party
Renyi Qin (Clinical professor, Tongji Hospital) — Principal investigator
First posted
Feb 22, 2018
Start date
Mar 1, 2018 (estimated)
Primary completion
Mar 1, 2020 (estimated)
Completion
Mar 1, 2021 (estimated)
Last update
Mar 1, 2018

Study contacts

Hang Zhang, doctor
Contact
okashiiyo@126.com
+8602783665314
Renyi Qin, pHD
study chair · Tongji Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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