- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05804201
EUS-guided Hepatico-gastrostomy With Hot Giobor
June 1, 2023 updated by: CHAN SHANNON MELISSA, Chinese University of Hong Kong
A Prospective, Single-center, Single-arm Study to Evaluate the Safety and Effectiveness of a Long Partially Covered Metal Stent With Hot Delivery System (Hot Giobor) for EUS-guided HGS in Patients With Malignant Biliary Obstruction
Endoscopic ultrasonography-guided hepaticogastrostomy (EUS-HGS) is a method of obtaining biliary drainage in patients with failed or difficult endoscopic retrograde cholangiopancreatography (ERCP).
The reason for failure of ERCP can be due to gastric outlet obstruction or failed cannulation.
HGS involves placement of a stent between the bile duct and the stomach under the guidance of endoscopic ultrasound to create a biliary drainage route similar to surgery.
The overall reported success rate is 94% with an overall complication rate of 14%.
The most common complications include pneumoperitoneum (air leaking into the abdomen) and bile leak.
Both complications are usually managed conservatively.
EUS-gudied HGS has been commonly performed but the type of stent used for the procedure is still under evolution.
A specific stent is needed to prevent complications.
The most commonly used stent in HK is a hybrid stent where the liver portion is uncovered to avoid stent migration and the rest of the stent is covered to avoid bile leakage and pneumoperitonum.
This stent is already available and is called the Giobor stent.
However, in order to use this stent, during the EUS procedure, the bile duct needs to be first punctured by a EUS needle, then a guidewire passed, then dilate the tract with an energy deviced 6Fr cytotome, then the stent can be passed.
This process is cumbersome and increase the chance of complications during exchange of the devices.
A newly developed stent that is cautery-fitted has been developed.
The use of this stent shortens the steps of stent application.
The current study aims to evaluate the feasibility and safety of a novel stent that is cautery-fitted designed for performance of EUS-HGS (Niti-S HOT Giobor).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shannon Melissa Chan
- Phone Number: 35052627
- Email: shannonchan@surgery.cuhk.edu.hk
Study Locations
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Hong Kong, Hong Kong, 00000
- The Chinese Universtiy of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Consecutive patients ≥ 18 years old
- Anatomically feasible for EUS-guided hepatico-gastrotomy
- Patient with clinical symptoms and/or sign of extra-hepatic biliary obstruction (jaundice, biliary-type pain, cholangitis)
- Patients with unsuccessful ERCP (failed ECRP, anticipated difficult ERCP or high risk for pancreatitis)
- Written informed consent (and assent when applicable) obtained from subject
Exclusion Criteria:
- Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder)
- Life expectancy of less than 1 month
- History of gastric surgery
- Coagulation disorders
- Pregnancy, breastfeeding, or unwilling to practice birth control during participation in the study
- Severe allergy to Nickel
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: HOT Giobor
EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giobor (Taewoong Medical, Gyeonggi-do, Korea), a novel device designed for hepatico-gastrostomy.
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(2) The EUS procedure will be performed with a therapeutic echoendoscope with a large working channel under guidance of ultrasound, endoscopy, and fluoroscopy.
The echoendoscope will be positioned in the stomach or duodenum.
Liver segment III, or sometimes segment II, will be punctured with an 19G needle.
After puncture, a guidewire will be introduced in the dilated bile duct, and a Hot Giobor will be placed.
All procedures will be performed with the patient and in the supine or prone position under monitored anesthesia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural / Device related serious adverse events
Time Frame: 1 month
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Any related serious adverse events occured in 1 month post procedure
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1 month
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Bilirubin level improvement
Time Frame: 1 month
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Bilirubin level improvement is defined as: > 50% serum bilirubin level is decreased from baseline.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical success
Time Frame: During index procedure
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Hot Giobor stent is placed at the desired site: transmural placement of the Hot Giobor stent across the stomach or duodenum into the bile duct.
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During index procedure
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Clinical success
Time Frame: At day 7
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Bilirubin level improvement is defined as: >20% serum bilirubin level is decreased from baseline.
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At day 7
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Stent patency
Time Frame: At 3, 6, 9 and 12 months
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Time between stent placement and stent occlusion &/or stent removal.
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At 3, 6, 9 and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shannon Melissa Chan, Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 15, 2023
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
March 27, 2023
First Submitted That Met QC Criteria
March 27, 2023
First Posted (Actual)
April 7, 2023
Study Record Updates
Last Update Posted (Actual)
June 2, 2023
Last Update Submitted That Met QC Criteria
June 1, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2022.460
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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