Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202203635372753 Date of Approval: 03/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Using EUS-guided biliary drainage as a primary modality to drain distal malignant biliary obstruction
Official scientific title Primary EUS-guided biliary drainage Versus ERCP biliary drainage in distal malignant biliary obstruction
Brief summary describing the background and objectives of the trial For more than three decades, drainage of the bile duct has been carried out using endoscopic retrograde cholangiopancreatography (ERCP) with a high success rate; however, it is not free of complications; pancreatitis, bleeding, and perforation are the most common complications, with rates ranging from 3 to 15%. ( Masci E et al., 2003). When ERCP is not successful, Traditionally those patients have been managed with percutaneous transhepatic biliary drainage (PTBD) or surgery (Ferrucci JT Jr et al., 1980). The potential complications associated with these procedures, along with the patient dissatisfaction associated with external drainage make these options less desirable. (Artifon EL et al., 2006). In recent years, endoscopic ultrasound (EUS) has evolved from a purely diagnostic procedure to a therapeutic one. Wiersema et al. first reported EUS-guided cholangiopancreatography in 1996. Subsequently, EUS-guided cholangiopancreatography followed by biliary drainage (BD) has been performed with many case reports and series confirming both the success and safety of this technique. EUS-BD offers several advantages over both PTBD and surgery. First, EUS-BD can be performed at the time of the initial ERCP, without a need for further delay or additional procedures. In addition, EUS-BD provides internal drainage as opposed to the external biliary drain that accompanies PTBD and has been associated with significant patient dissatisfaction. Our study Compare primary EUS- biliary drainage vs. ERCP in malignant obstruction of the distal bile duct: As regard success (technical and clinical), adverse events, timing, costs and need for reintervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2021
Actual trial start date 01/12/2021
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ERCP group once one day Patients will be subjected to transpapillary drainage via ERCP with the placement of a self-expanded metal stent. 33 Active-Treatment of Control Group
Experimental Group EUS guidied biliary drainage once one day Patients will be subjected to biliary drainage via EUS-guided choledochoduodenostomy or hepaticogastrostomy. 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients older than 18 years and diagnosed with malignant obstruction of the distal bile duct. • Type of malignancy:  Primary pancreatic cancer.  Ampulla of vater carcinoma.  Distal cholangiocarcinoma.  Pancreatic neuroendocrine tumor.  Metastatic lymph nodes.  Resectable and unresectable tumors will be included.  Patients with duodenal tumor invasion will be included. • Patients with performance A will be included. Exclusion criteria: • Patients with impaired coagulation profile. • Patients with sepsis (according to the severity of sepsis index). • Low performance. • Life expectancy less than 1 month. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/04/2021 Egyptian Liver Hospital
Ethics Committee Address
Street address City Postal code Country
Sherbeen Shebeen 6000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of effectiveness and Safty of EUS guided biliary drainage as a primary tool. Forty eight hours, one week and one month after the procedure we will assess relivement of biliary obstruction absence of bilary leak, perforation and intrabdomin collection and stent migrational
Secondary Outcome Assessment improvement of sepsis One week after procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Rajhi liver Hospital Univeristy street Assiut Egypt
Egyptian Liver Hospital Sherbeen Sherbeen Egypt
Theodor Bilharz Research institute Kornish Alneel GIZA Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alrajhi liver Hospital Univeristy street Assuit 71511 Egypt
Egyptian Liver Hospital Sherbeen Sherbeen 35661 Egypt
Theodor Bilharz Reasearch Institute Kornish Alneel Warak GIZA 12651 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Theodr Bilharz Research institute Kornish Alneel GIZA Egypt Hospital
Primary Sponsor Egyptian liver Hospital Sherbeen Sherbeen Egypt Hospital
Primary Sponsor Shefaa Al Orman Hospital Alrajhi liver hospital Assiut Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khalid Ragab khalidmohamedragab@yahoo.com +20009646294 Kornish Alneel
City Postal code Country Position/Affiliation
GIZA Egypt Researcher of gastroenterology and Hepatology Theodor Bilharz research institute
Role Name Email Phone Street address
Scientific Enquiries Alsayed Ghoneem ghoneem_84@yahoo.com +201090254625 univeristy hospital
City Postal code Country Position/Affiliation
Mansoura Egypt Researcher of gastroenterology Mansoura univeristy
Role Name Email Phone Street address
Public Enquiries Mohamed Kandyl drmkandyl84@gmail.com +201114886247 Kornishalneel
City Postal code Country Position/Affiliation
GIZA Egypt Researcher of Gastroenterology and Hepatology Theodor Bilharz Reseach Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data requests can be submitted starting after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by­ case basis. Statistical Analysis Plan,Study Protocol Data requests can be submitted starting after article publication and the data will be made accessible for up to 24 months. EUS guided biliary drainage Hepaticogasterostomy Choledochoduodenostomy
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information