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

NCT ID: NCT04874103

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-06
• Study Completion Date: 2023-09-15

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.

Detailed Description

Acute cholecystitis is a common surgical condition. However, in elderly patients or patients with significant comorbidity, emergency laparoscopic cholecystectomy can be associated with significant risk of morbidities. Thus, in these patients, percutaneous cholecystostomy (PC) could be employed for drainage of the gallbladder. However, complications including intrahepatic hemorrhage, pneumothorax, biliary peritonitis and pneumonia have been reported in a mean of 6.2% of patients (range 0-25%). Furthermore, PC has several other disadvantages including risk of bile leakage, recurrent cholecystitis, inadvertent tube removal and migration (0-25%), necessitating repeated procedures. In order to avoid nuisances associated with PC, studies looking at potential ways to achieve endoscopic gallbladder drainage have been performed. On the other hand, EUS-guided transmural drainage procedures are increasingly performed for management of a variety of conditions and has also been described for drainage of the gallbladder in patients that are not fit for surgery since 2007. Recently, a lumen-apposing metal stent (LAMS) has become available which allows easier deployement of the stent. A 9.8mm gastroscope or a 5mm ultrathin nasal endoscope can pass through the lumen of the stent and enter the gallbladder for stone removal or other interventions A recent study group from Hong Kong promoted a specific follow up for EUS guided gallbaldder drainage patients who underwent a follow-up cholecystoscopy after the procedure to check for clearance of stones. In patients with stones that were too large to pass out spontaneously, basket mechanical lithotripsy was employed to break down the stones, followed by laser lithotripsy if the latter was not successful. No data on the safety and efficacy of the Hong Kong follow up protocol in patients who underwent EGBD using LAMS coming from countries other than Asian are available, in which differences in etiological and pathogenic factors might not required such an intensive follow up protocol. To explore this important question we have designed a study aimed at evaluating the long-term safety and efficacy of the Hong Kong follow up protocol in patients undergoing EGBD performed using LAMS.

Conditions

Cholecystitis, Acute

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Guido Costamagna

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Larghi, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli

Locations

Universita' Cattolica del Sacro Cuore

Rome, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 17767933 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20091665 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17725950 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27875855 (View on PubMed)

Other Identifiers

EUS-GBD Hong Kong

Identifier Type: -

Identifier Source: org_study_id