EUS-guided Hepatico-gastrostomy With Hot Giobor

NCT05804201 | Unknown DMC

• 1 other identifier: 2022.460
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

EUS-guided hepatico-gastrostomy, malignant biliary obstruction

Outcome Measures

Primary Outcomes (2)

• Procedural / Device related serious adverse events

  Any related serious adverse events occured in 1 month post procedure

  1 month

• Bilirubin level improvement

  Bilirubin level improvement is defined as: \> 50% serum bilirubin level is decreased from baseline.

  1 month

Secondary Outcomes (3)

• Technical success

  During index procedure

• Clinical success

  At day 7

• Stent patency

  At 3, 6, 9 and 12 months

Study Arms (1)

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.

Procedure: EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob

Interventions

EUS-guided hepatico-gastrostomy would be performed with Niti-S HOT Giob PROCEDURE

(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.

HOT Giobor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese Universtiy of Hong Kong

Hong Kong, 00000, Hong Kong

Location

Study Officials

• Shannon Melissa Chan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Melissa Chan

CONTACT

35052627; shannonchan@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: June 15, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)