Ultrasonography as a Single Tool for Guided Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice
Primary Purpose
Obstructive Jaundice
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
nephrostomy set
Sponsored by
About this trial
This is an interventional other trial for Obstructive Jaundice
Eligibility Criteria
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.
Sites / Locations
- Sohag University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cases
Arm Description
group of patient with inoperable malignant obstructive jaundice with failed internal drainage.
Outcomes
Primary Outcome Measures
Correction of hyperbilirubinemia.
We correct hyperbilirubinemia in patient with malignant obstructive jaundice using ultrasound to insert external drain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05246176
Brief Title
Ultrasonography as a Single Tool for Guided Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice
Official Title
Role of Ultrasonography as a Single Tool for Guidance of Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Jaundice
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cases
Arm Type
Experimental
Arm Description
group of patient with inoperable malignant obstructive jaundice with failed internal drainage.
Intervention Type
Device
Intervention Name(s)
nephrostomy set
Intervention Description
insertion of the nephrostomy set through the skin to obtaining good external drainage of bile in case of malignant obstructive jaundice.
Primary Outcome Measure Information:
Title
Correction of hyperbilirubinemia.
Description
We correct hyperbilirubinemia in patient with malignant obstructive jaundice using ultrasound to insert external drain.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa A Ahmed, resident
Phone
01127688037
Email
mostafa011186@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Medhat I Mohamed, ass. professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R ElSherif, professor
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28287940
Citation
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. Damodharan, Karthik [corrected to Damodharan, Karthikeyan].
Results Reference
background
PubMed Identifier
27829281
Citation
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.
Results Reference
background
PubMed Identifier
26962281
Citation
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.
Results Reference
background
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Ultrasonography as a Single Tool for Guided Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice
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