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

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Recruiting

CT.gov ID

NCT04874103

Collaborator

(none)

Enrollment

Location

42.8

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholecystitis, Acute

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Endoscopic Ultrasound-guided Gallbladder Drainage in High Surgical Risk Patients With Acute Cholecystitis: Prospective Evaluation of the Hong Kong Follow up Protocol

Actual Study Start Date :

May 6, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Incidence of adverse events after EUS gallbladder drainage and cholecystoscopy [From date of treatment every 2-3 months, assessed until death or up to 2 years]
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.
Incidence of recurrent acute cholecystitis after EUS-GBD and cholecystoscopy [From date of treatment, every 2-3 months, assessed until death or up to 2 years]
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.

Secondary Outcome Measures

Incidence of patients with resolution of acute cholecystitis symptoms after EUS-GBD [Within 96 hours after procedure]
Percetange of patients achieving acute cholecystitis symptoms resolution after EUS-GBD demonstrated by normalization of clinical parameters of acute cholecystitis within 96 hours. Clinical parameters reported are abdominal pain evaluated by the patients on a 10-point visual analogue scale, temperature, white blood cell count and serum C-reactive protein concentration.
Need for advaced gallbladder interventions [From date of treatment, every 2-3 months, assessed until death or up to 2 years]
Number of patients who will require more advanced gallbladder interventions during follow up such as colecystoscopy lithotripsy will be assessed by the numebr of patients who will require such treatments.
Need for ERCP [From date of treatment, every 2-3 months, assessed until death or up to 2 years]
rate of patients who will require ERCP due to stones migration during colecystoscopy will be assessed by the number of patients who will require such intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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