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

S

Sohag University

Status

Unknown

Conditions

Obstructive Jaundice

Treatments

Device: nephrostomy set

Study type

Interventional

Funder types

Other

Identifiers

NCT05246176
Soh-Med-22-1-02

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Cases
Experimental group
Description:
group of patient with inoperable malignant obstructive jaundice with failed internal drainage.
Treatment:
Device: nephrostomy set

Trial contacts and locations

1

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Central trial contact

Mostafa A Ahmed, resident; Medhat I Mohamed, ass. professor

Data sourced from clinicaltrials.gov

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