NCT05979233

Brief Summary

to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 30, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

August 5, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

July 30, 2023

Last Update Submit

October 11, 2023

Conditions

Calcular Obstructive JaundiceGall Bladder Disease

Outcome Measures

Primary Outcomes (2)

  • total cost

    total cost in Egyptian pound

    6 months

  • hospital stay

    total hospital stay in days

    6 months

Secondary Outcomes (1)

  • complications

    30 days

Study Arms (3)

staged managment

ACTIVE COMPARATOR

ERCP then interval laparoscopic cholecystectomy

Procedure: staged managment

one session ERCP then LC

EXPERIMENTAL

one session ERCP then LC

Procedure: one session ERCP then LC

one session LC then ERCP

EXPERIMENTAL

one session LC then ERCP

Procedure: one session LC then ERCP

Interventions

staged managmentPROCEDURE

staged management

staged managment
one session ERCP then LCPROCEDURE

one session ERCP then LC

one session ERCP then LC
one session LC then ERCPPROCEDURE

one session LC then ERCP

one session LC then ERCP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age from 18-70 year
  • combined CBD and gall stone
  • stone less than 1.5 cm
  • fit for surgery
  • no upper abdominal surgery

You may not qualify if:

  • age \<18 and \>70
  • unfit for surgery
  • stone more than 1.5 cm
  • upper abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Minya, 61511, Egypt

RECRUITING

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, professor & consultant of general surgery, Department of surgery, Minia university hospital, Egypt

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 7, 2023

Study Start

August 5, 2023

Primary Completion

February 15, 2024

Study Completion

February 20, 2024

Last Updated

October 13, 2023

Record last verified: 2023-10

Locations

EG(1)