NCT05927870

Brief Summary

Surgical cholecystostomy has proven value in the management of both inflammatory and obstructive biliary tract disease

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

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

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 14, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

June 23, 2023

Last Update Submit

July 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • value of cholecystostomy as preoperative step in critically ill patients

    The aim of this study was to assess the clinical outcomes of PCT use, with particular emphasis on a subgroup of patients who did not proceed to cholecystectomy.

    basline

Study Arms (1)

pyocele

EXPERIMENTAL

obstructed gallbladder with infection on top

Procedure: pigtail

Interventions

pigtailPROCEDURE

placing a small amount of local anaesthetic subcutaneously at the site of the gallbladder, a skin incision was made through which the catheter was introduced. A 7-Fr pigtail catheter was used in all cases . If possible, the catheter was introduced into the gallbladder after passing through the liver. The catheter was thereafter fixed, either by an internal locking device or by means of a suture to the skin. The catheter was rinsed with saline solution daily in order to prevent clogging.

pyocele

Eligibility Criteria

Age4 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pyocele of the gallbladder
  • Mucocele of the gallbladder
  • Perforated gallbladder
  • Malignant causes of gallbladder obstruction

You may not qualify if:

  • Uncontrolled bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Akhan O, Akinci D, Ozmen MN. Percutaneous cholecystostomy. Eur J Radiol. 2002 Sep;43(3):229-36. doi: 10.1016/s0720-048x(02)00158-4.

    PMID: 12204405BACKGROUND

Related Links

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Central Study Contacts

Basma Fawzy Abd Elhameed, Resident doctor

CONTACT

Mostafa Hashem Mahmoud Othman, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

August 1, 2023

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

July 14, 2023

Record last verified: 2023-06