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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05246176
Collaborator
(none)
50
1
1
13
3.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: nephrostomy set
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Role of Ultrasonography as a Single Tool for Guidance of Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice
Actual Study Start Date :
Jul 15, 2021
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cases

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

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

Outcome Measures

Primary Outcome Measures

  1. Correction of hyperbilirubinemia. [4 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Any adult Patients with malignant obstructive jaundice will included in this study
Exclusion Criteria:
  • Patients with bleeding diathesis.

  • Patients with associating comorbidities.

  • Patients with insufficient intrahepatic biliary dilatation < 0.5 cm or with extensive tumor infiltrates.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mostafa Aboelmakarem Ahmed, Principal investigator, Sohag University
ClinicalTrials.gov Identifier:
NCT05246176
Other Study ID Numbers:
  • Soh-Med-22-1-02
First Posted:
Feb 18, 2022
Last Update Posted:
Feb 18, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2022