Malignant Biliary ObstructionNCT05804201
EUS-guided Hepatico-gastrostomy With Hot Giobor
A study testing EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob in people with Malignant Biliary Obstruction, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jun 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Malignant Biliary Obstruction
- Being tested
- EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob
- Keywords
- EUS-guided hepatico-gastrostomy, malignant biliary obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT GiobProcedure or surgery
(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.
| Study group | Role | What they receive |
|---|---|---|
| HOT Giobor | Other | EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giobor (Taewoong Medical, Gyeonggi-do, Korea), a novel device designed for hepatico-gastrostomy. Receives: Procedure: EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural / Device related serious adverse events
Any related serious adverse events occured in 1 month post procedure
Measured: 1 month
Bilirubin level improvement
Bilirubin level improvement is defined as: > 50% serum bilirubin level is decreased from baseline.
Measured: 1 month
Secondary outcomes (3)
Technical success
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.
Measured: During index procedure
Clinical success
Bilirubin level improvement is defined as: >20% serum bilirubin level is decreased from baseline.
Measured: At day 7
Stent patency
Time between stent placement and stent occlusion \&/or stent removal.
Measured: At 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start15 Jun 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN SHANNON MELISSA, Chinese University of Hong Kong
- Investigators
- Shannon Melissa Chan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804201
- Sponsor's protocol ID
- 2022.460
- Status last verified
- Jun 2023
- First submitted
- 27 Mar 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05804201
- Acronym / sponsor ID
- 2022.460
- Conditions
- Malignant Biliary Obstruction
- Keywords
- EUS-guided hepatico-gastrostomy, malignant biliary obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOT Giobor | Other | Procedure: EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT GiobEUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giobor (Taewoong Medical, Gyeonggi-do, Korea), a novel device designed for hepatico-gastrostomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob(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. | Procedure or surgery | HOT Giobor |
Primary outcome
Procedural / Device related serious adverse events
Time frame: 1 month
Any related serious adverse events occured in 1 month post procedure
Bilirubin level improvement
Time frame: 1 month
Bilirubin level improvement is defined as: > 50% serum bilirubin level is decreased from baseline.
3 secondary outcomes
Technical success
Time frame: During index procedure
Clinical success
Time frame: At day 7
Stent patency
Time frame: At 3, 6, 9 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Melissa Chan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob in people with Malignant Biliary Obstruction, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannon Melissa Chan (35052627, shannonchan@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural / Device related serious adverse events (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.