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Not yet recruitingNCT05927870Updated Jul 14, 2023

Ultrasound Guided Percutaneous Cholecystostomy.

An interventional study of pigtail in Gall Bladder Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 4 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-14.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
4 Years to 100 Years
Sex
All
01

Study summary

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

Read the detailed description

The etiology of biliary obstruction can be benign or malignant. Benign disease, such as calculi, strictures, or pancreatitis, can be common causes in adult patients [5], whereas benign strictures including posttransplant anastomotic strictures and strictures secondary to hepatic artery insufficiency, stone disease, infection, and iatrogenic causes can be seen in children [6]. Obstruction can also be seen in the setting of biliary tract abnormalities, such as biliary atresia in neonates and symptomatic choledochal cysts, autoimmune pancreatitis, and sclerosing cholangitis in older children [7]. Biliary obstruction secondary to neoplasm commonly occurs with pancreatic cancer, cholangiocarcinoma, or metastases in adult patients and biliary rhabdomyosarcoma or neuroblastoma in younger patients [8].

The question remains as to whether all patients undergoing PCT drainage require a definitive cholecystectomy. Previous publications have suggested that there is a reluctance to use PCT in older and comorbid patients due to concerns of potentially committing such patients to an interval surgical procedure for which they may not be suitable.

02

Conditions studied

  • Gall Bladder Disease

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03

In context

Gallbladder Diseases

92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.

This study's planned enrollment of 50 is below the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.

Browse Gallbladder Diseases 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
4 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled bleeding disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    pyocele

    obstructed gallbladder with infection on top

    Procedure: pigtail

Interventions

  • Procedurepigtail

    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.

06

What researchers measure

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.

    Time frame: basline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 12204405 ↗

Related links

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 Aug 2023; primary completion for Jul 2024, 11 months later.

Of 32 non-industry interventional studies with no phase under Gallbladder Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 11 months is below that.

Counting every sponsor, half of 34 studies reached it within 14 months; a quarter within 8 and three quarters within 26.

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

Registered
Jun 23, 2023
First posted
Jul 3, 2023
StartEst.
Aug 1, 2023
Primary completionEst.
Jul 1, 2024
CompletionEst.
Sep 1, 2024
Last update
Jul 14, 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 Jul 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05927870
Lead sponsor
Assiut University
Responsible party
Basma Fawzy Abd Elhameed Ali (Resident doctor, Assiut University) — Principal investigator
First posted
Jul 3, 2023
Start date
Aug 1, 2023 (estimated)
Primary completion
Jul 1, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Jul 14, 2023

Study contacts

Basma Fawzy Abd Elhameed, Resident doctor
Contact
basmafawzy80@gmail.com
01062649652
Mostafa Hashem Mahmoud Othman, professor
Contact
hashemradiol@yahoo.com
01000684012

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 Jun 2023. You cannot join it, but the record below documents what was studied.

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