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.: PACTR202203696639414 Date of Approval: 03/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EUS guided biliary drainage in patients with distal malignant obstructive jaundice using double pigtail stent
Official scientific title Feasibility of double pigtail plastic stent in EUS guided hepatico -gasrosotmy
Brief summary describing the background and objectives of the trial 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 percutaneous transhepatic biliary drainage (PTBD) and surgery. EUS-guided biliary drainage EUS (EUS-BD) has been shown to have a high success rate and an acceptable complication rate. In our study, we will assess the feasibility of using plastic double pigtail in EUS guided hepatico-gastrostomy.
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 01/03/2022
Actual trial start date
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Active, not 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 Follow up for one month after the procedure Patients with distal malignant obstructive jaundice will be subjected to drainage of the biliary system through standard ERCP 15 Active-Treatment of Control Group
Experimental Group Hepaticogastrostomy double pigtail plastic stent group Follow up for one month after the procedure EUS guided Hepaticogastrostomy using double pigtail plastic stent 15
Experimental Group Hepaticogastrosomy metal stent group Follow up after one month from the procedure EUS guided biliary drainage using a metal stent 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients older than 18 years Diagnosed with malignant obstruction of the distal bile duct. Patients with performance A will be included. Patients with impaired coagulation profile. Low performance. Life expectancy less than 1 month. 80 and over: 80+ Year,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
No 31/03/2022 Egptian Liver Hospital
Ethics Committee Address
Street address City Postal code Country
Univeristy hospital Sherbeen 35661 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assess effectiveness and Safty of using double pigtail plastic stent in EUS guided hepaticogasterostomy Fourty eight hours, one week and one month after the procedure we will assess relivement of biliary obstruction, absence of bilary leak, perforation and intrabdominal collection and stent migration
Secondary Outcome Assessment of bilobar drainage in case of Pigtail plastic stenting One week after procedure by US
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Theodor Bilharz Research Institute TBRI Kornsh Alneel Alwarak GIZA Egypt
Specialized internal medicine Mansoura Univeristy street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor TBRI Kornish Alneel Warak Giza Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ragab Ragab Khalidmohamedragab@yahoo.com 00201009646294 Kornish Alneel
City Postal code Country Position/Affiliation
Warak GIZA Egypt Researcher of gasteroenterology and Hepatology TBRI
Role Name Email Phone Street address
Public Enquiries MOHAMED KANDYL drmkandyl84@gmail.com 00201114886247 Kornish Alneel
City Postal code Country Position/Affiliation
GIZA Egypt Researcher of gasteroenterology and Hepatology TBRI
Role Name Email Phone Street address
Scientific Enquiries Elsayed Ghoneem ghoneem_84@yahoo.com +201090254625 Univeristy street
City Postal code Country Position/Affiliation
Mansoura Egypt Lecture of Gasteroenterology and Hepatology faculty of medicine Mansoura univeristy.
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. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Double pigtail plastic stent EUS guided hepaticogasrosotmy Distal malignant obstruction
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