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Status unknownNCT05246176Updated Feb 18, 2022

Ultrasonography as a Single Tool for Guided Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice

An interventional study of nephrostomy set in Obstructive Jaundice, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by Sohag University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2021, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Obstructive jaundice may be of malignant and benign etiologies. Carcinoma of the gall bladder, cholangiocarcinoma, pancreatic adenocarcinoma, metastasis, and lymph nodal compression of common bile duct (CBD) constitute the majority of malignant causes.

Most of the patients with malignant obstructive jaundice are already advanced and inoperable by the time they are diagnosed, hence carry bad prognosis with palliation being the only option left. Obstruction needs to be drained even in such cases for reducing pain, cholangitis, anorexia and pruritus as well as to reduce the serum bilirubin levels in certain cases to initiate chemo or intrabiliary brachytherapy.

Over the years, palliation has evolved with the introduction of newer methods and improvisation of existing techniques. Recent palliative measures prolong longevity and improve the quality of life, hence increasing the acceptance to such procedures; Methods of biliary drainage include: a. Surgical bypass b. Minimally invasive procedures; Endoscopic retrograde (ERCP) (cholangiopancreatography (ERCP), and Percutaneous transhepatic biliary drainage (PTBD).

ERCP as well as PTBD are well-established and effective means for biliary drainage as palliative treatment in unresectable cases.

With the current modern technique in experienced hands, Percutaneous Transhepatic Biliary Drainage (PTBD) equals endoscopic retrograde cholangio pancreatography (ERCP) regarding technical success and complications. In addition, there is a reduction in immediate procedure-related mortality with proven survival benefit. Moreover, it is the only immediate lifesaving procedure in cholangitis and sepsis.

02

Conditions studied

  • Obstructive Jaundice

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03

In context

Jaundice, Obstructive

62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.

This study's planned enrollment of 50 is below the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.

Browse Jaundice, Obstructive studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 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

  • Any adult Patients with malignant obstructive jaundice will included in this study

Exclusion criteria

Exclusion Criteria:

  • Patients with bleeding diathesis.
  • Patients with associating comorbidities.
  • Patients with insufficient intrahepatic biliary dilatation \< 0.5 cm or with extensive tumor infiltrates.
05

Study design

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

Study arms

  • Experimental
    Cases

    group of patient with inoperable malignant obstructive jaundice with failed internal drainage.

    Device: nephrostomy set

Interventions

  • Devicenephrostomy set

    insertion of the nephrostomy set through the skin to obtaining good external drainage of bile in case of malignant obstructive jaundice.

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What researchers measure

Primary outcomes

  1. Correction of hyperbilirubinemia.

    We correct hyperbilirubinemia in patient with malignant obstructive jaundice using ultrasound to insert external drain.

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Sohag University Hospital
    Sohag, Egypt
    Recruiting
    • Osama R ElSherif, professor · Contact
08

References and documents

Publications

  • Venkatanarasimha N, Damodharan K, Gogna A, Leong S, Too CW, Patel A, Tay KH, Tan BS, Lo R, Irani F. Diagnosis and Management of Complications from Percutaneous Biliary Tract Interventions. Radiographics. 2017 Mar-Apr;37(2):665-680. doi: 10.1148/rg.2017160159. Erratum In: Radiographics. 2017 May-Jun;37(3):1004. doi: 10.1148/rg.2017174004.. Damodharan, Karthik [corrected to Damodharan, Karthikeyan]. PubMed 28287940 ↗
  • Yarmohammadi H, Covey AM. Percutaneous biliary interventions and complications in malignant bile duct obstruction. Chin Clin Oncol. 2016 Oct;5(5):68. doi: 10.21037/cco.2016.10.07. PubMed 27829281 ↗
  • Gamanagatti S, Singh T, Sharma R, Srivastava DN, Dash NR, Garg PK. Unilobar Versus Bilobar Biliary Drainage: Effect on Quality of Life and Bilirubin Level Reduction. Indian J Palliat Care. 2016 Jan-Mar;22(1):50-62. doi: 10.4103/0973-1075.173958. PubMed 26962281 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05246176
Lead sponsor
Sohag University
Responsible party
Mostafa Aboelmakarem Ahmed (Principal investigator, Sohag University) — Principal investigator
First posted
Feb 18, 2022
Start date
Jul 15, 2021
Primary completion
Jun 15, 2022 (estimated)
Completion
Aug 15, 2022 (estimated)
Last update
Feb 18, 2022

Study contacts

Mostafa A Ahmed, resident
Contact
mostafa011186@med.sohag.edu.eg
01127688037
Medhat I Mohamed, ass. professor
Contact

Oversight

Data monitoring committee
No
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 2022. You cannot join it, but the record below documents what was studied.

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