NCT05246176

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

January 12, 2022

Last Update Submit

February 17, 2022

Conditions

Obstructive Jaundice

Outcome Measures

Primary Outcomes (1)

  • Correction of hyperbilirubinemia.

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

    4 weeks

Study Arms (1)

Cases

EXPERIMENTAL

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

Device: nephrostomy set

Interventions

nephrostomy setDEVICE

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

Cases

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28287940BACKGROUND

  • 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.

    PMID: 27829281BACKGROUND

  • 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.

    PMID: 26962281BACKGROUND

MeSH Terms

Conditions

Jaundice, Obstructive

Condition Hierarchy (Ancestors)

JaundiceHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Central Study Contacts

Mostafa A Ahmed, resident

CONTACT

01127688037mostafa011186@med.sohag.edu.eg

Medhat I Mohamed, ass. professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 12, 2022

First Posted

February 18, 2022

Study Start

July 15, 2021

Primary Completion

June 15, 2022

Study Completion

August 15, 2022

Last Updated

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Locations

EG(1)