Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis

NCT04874103 | Completed

• 1 other identifier: EUS-GBD Hong Kong
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the long-term safety and efficacy of the Hong Kong follow up protocol in patients who will undergo drainage of the gallbladder under endoultrasonography (EUS) guidance in patients with acute cholecistitis not suitable for surgery.

Conditions

Cholecystitis, Acute

Keywords

endoscopic ultrasound; eus; acute cholecistitis; gallbladder drainage

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events after EUS gallbladder drainage and cholecystoscopy

  Percentage adverse events after the procedures. Adverse events will be considered major if they prevent completion of the scheduled procedure and/or resulted in prolongation of hospital stay, another therapeutic procedure (needing sedation/anesthesia), or subsequent medical consultation. Any potential adverse event such as pancreatitis, burns of the gastric or duodenal walls, bowel injury, or peritonitis will be recorded and graded according to the above-mentioned classification.

  From date of treatment every 2-3 months, assessed until death or up to 2 years

• Incidence of recurrent acute cholecystitis after EUS-GBD and cholecystoscopy

  Percentage of patients with recurrent acute cholecystitis symptoms after EUS-GBD and cholecystoscopy with residual stone removal if present after resolution of the index episode.

  From date of treatment, every 2-3 months, assessed until death or up to 2 years

Secondary Outcomes (3)

• Incidence of patients with resolution of acute cholecystitis symptoms after EUS-GBD

  Within 96 hours after procedure

• Need for advaced gallbladder interventions

  From date of treatment, every 2-3 months, assessed until death or up to 2 years

• Need for ERCP

  From date of treatment, every 2-3 months, assessed until death or up to 2 years

Study Arms (1)

EUS guided gallbladder drainage and cholecystoscopy

EUS-GBD will be performed using LAMS (such as Hot-AxiosTM device). A 10mm x 10mm stent system will be used if the largest gallstone is smaller than 10mm in size and a 15 x 10mm stent will be used if the largest gallstone is larger than 10mm. Colecystoscopy will be subsequently performed after at least 2 weeks using standard or therapeutic gastroscope. Lithotripsy will be performed using mechanical lithotripsy or laser lithotripsy.

Eligibility Criteria

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

Study Population

This study concerns consecutive patients undergoing EGBD using LAMS as per decision of the on call surgeons of the Emergency Surgery Department with diagnosis of acute cholecystitis, who are unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions

You may qualify if:

• Consecutive patients with acute cholechystitis unsuitable for surgery
• age ≥ 18 years old
• Written informed consent from patient or guardian who is able to understand the nature and possible consequences of the study

You may not qualify if:

• Pregnancy
• Patients unwilling to undergo follow-up assessments
• Patients with suspected gangrene or perforation of the gallbladder
• Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
• Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
• Patients with liver cirrhosis, portal hypertension and/or gastric varices
• Abnormal coagulation (INR \> 1.5 and/or platelets \< 50.000/mm3)
• Contraindication to perform endoscopy

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Universita' Cattolica del Sacro Cuore

Rome, 00136, Italy

Location

Related Publications (4)

• Lee SS, Park DH, Hwang CY, Ahn CS, Lee TY, Seo DW, Lee SK, Kim MW. EUS-guided transmural cholecystostomy as rescue management for acute cholecystitis in elderly or high-risk patients: a prospective feasibility study. Gastrointest Endosc. 2007 Nov;66(5):1008-12. doi: 10.1016/j.gie.2007.03.1080. Epub 2007 Sep 4.

  PMID: 17767933 BACKGROUND

• Keus F, Gooszen HG, van Laarhoven CJ. Open, small-incision, or laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis. An overview of Cochrane Hepato-Biliary Group reviews. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD008318. doi: 10.1002/14651858.CD008318.

  PMID: 20091665 BACKGROUND

• Kwan V, Eisendrath P, Antaki F, Le Moine O, Deviere J. EUS-guided cholecystenterostomy: a new technique (with videos). Gastrointest Endosc. 2007 Sep;66(3):582-6. doi: 10.1016/j.gie.2007.02.065.

  PMID: 17725950 BACKGROUND

• Teoh AYB, Serna C, Penas I, Chong CCN, Perez-Miranda M, Ng EKW, Lau JYW. Endoscopic ultrasound-guided gallbladder drainage reduces adverse events compared with percutaneous cholecystostomy in patients who are unfit for cholecystectomy. Endoscopy. 2017 Feb;49(2):130-138. doi: 10.1055/s-0042-119036. Epub 2016 Nov 22.

  PMID: 27875855 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Alberto Larghi, MD, Phd

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 5, 2021
• Study Start: May 6, 2020
• Primary Completion: July 15, 2023
• Study Completion: September 15, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)