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

Obstructive Jaundice Clinical Trial

Official title:

Role of Ultrasonography as a Single Tool for Guidance of Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246176
• Other study ID #: Soh-Med-22-1-02
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: February 2022
• Source: Sohag University
• Contact: Mostafa A Ahmed, resident
• Phone: 01127688037
• Email: mostafa011186[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Obstructive
• Obstructive Jaundice

Intervention

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

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. Review. Erratum in: Radiographics. 2017 May-Jun;37(3):1004. Damodharan, Karthik [corrected to Damodharan, Karthikeyan]. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correction of hyperbilirubinemia.	We correct hyperbilirubinemia in patient with malignant obstructive jaundice using ultrasound to insert external drain.	4 weeks