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Not yet recruitingNCT05823181Updated Apr 21, 2023

Early Versus Late Laparoscopic Exploration of Common Bile Duct After Failure of Extraction of Common Bile Duct Stones by ERCP

An observational study in Common Bile Duct Calculi, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study summary

The goal of this work is to assess the best time to perform LC combined with LCBD exploration and the feasibility and safety of such procedure in patients with combined GBS and CBDS after failure of ERCP extraction of CBD stones .

02

Conditions studied

  • Common Bile Duct Calculi

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03

In context

Gallstones

199 studies on the registry are indexed under Gallstones; 35 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 70 observational studies indexed under Gallstones.

Browse Gallstones studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients that presented with calcular obstructive jaundice 2ry to CBD stones and failed of extraction of common bile duct stone by ERCP.

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

  1. All patients that presented with calcular obstructive jaundice 2ry to CBD stones.
  2. Failed of extraction of common bile duct stone by ERCP.

Exclusion criteria

Exclusion Criteria:

  1. patients presented by cholangitis.
  2. patients presented by acute pancreatitis.
  3. Patients that developed post ERCP pancreatitis ,bleeding , perforation.
  4. history of previous biliary surgery rather than cholecystectomy.
  5. history of major upper abdominal surgery.
  6. pregnant females.
  7. patients with liverchirosis, abdominal , and those unfit for surgery.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Early laparoscopic exploration of common bile duct

    Early laparoscopic exploration of common bile duct after failure of extraction of common bile duct stones by ERCP

    Device: laparoscopy

  • Late laparoscopic exploration of common bile duct

    late laparoscopic exploration of common bile duct after failure of extraction of common bile duct stones by ERCP

    Device: laparoscopy

Interventions

  • Devicelaparoscopy

    laparoscopic exploration of common bile duct

06

What researchers measure

Primary outcomes

  1. intraoperative complications

    1. Assess the operative time in hours 2. intraoperative blood loss in millilitres 3. intraoperative organ injury (yes or no) 4. conversion to open surgery (yes or no)

    Time frame: Baseline

Secondary outcomes

  1. postoperative complications

    1. Postoperative bleeding in millilitres 2. biliary leakage in millilitres 3. missed stone (yes or no) 4. recumbency complications which are monitored for 30 days postoperatively. 5.Overall length of hospital stay and if Intensive Care Unit (ICU) stay needed will also be recorded in days.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

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 Sep 2023; primary completion for Sep 2025, 24 months later.

Of 23 observational studies under Gallstones, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 61. This study's planned 24 months is below that.

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

Registered
Feb 25, 2023
First posted
Apr 21, 2023
StartEst.
Sep 1, 2023
Primary completionEst.
Sep 2025
CompletionEst.
Nov 2025
Last update
Apr 21, 2023
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 Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05823181
Lead sponsor
Assiut University
Responsible party
Ebram Abdelmalak Abd (Principal Investigator, Assiut University) — Principal investigator
First posted
Apr 21, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Apr 21, 2023

Study contacts

Ebram Abdelmalak Abd Awad, Resident dr
Contact
ebrammalak195@gmail.com
01208032279

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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