Clinical trial NCT02212717: A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.
Official title: Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Cholecystitis
Keywords: Acute cholecystitis
EUS-guided gallbladder drainage
Percutaneous cholecystostomy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
name: Tokyo Medical University
name: Kinki University
name: University of Barcelona
First posted: 2014-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in treatment of this condition has been demonstrated but how the two procedures compare to one another is uncertain.

The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients aged ≥ 18 years old admitted for acute cholecystitis but are unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions including: American society of anesthesiology grading ≥ 3, APACHE score ≥ 12, limited life expectancy (less than 2 years) or deemed unsuitable for general anesthesia would be included.
* 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
* Previous drainage of the gallbladder

Primary outcomes:
measure: Overall morbidities
timeFrame: 1 years
Secondary outcomes:
measure: Technical success
timeFrame: 30 days
measure: Pain scores
timeFrame: 7 days
measure: Analgesic requirements
timeFrame: 7 days
measure: Stone clearance rates
timeFrame: 1 years
measure: Clinical success
timeFrame: 30 days
measure: Reintervention rate
timeFrame: 1 year
measure: Re-admission rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
state: Hong Kong
city: Osaka
country: Japan
facility: Kinki University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Barcelona
country: Spain
facility: University Hospital Rio Hortega
Study officials:
References:
citation: de la Serna-Higuera C, Perez-Miranda M, Gil-Simon P, Ruiz-Zorrilla R, Diez-Redondo P, Alcaide N, Sancho-del Val L, Nunez-Rodriguez H. EUS-guided transenteric gallbladder drainage with a new fistula-forming, lumen-apposing metal stent. Gastrointest Endosc. 2013 Feb;77(2):303-8. doi: 10.1016/j.gie.2012.09.021. Epub 2012 Dec 1. No abstract available.
citation: Itoi T, Binmoeller KF, Shah J, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Moriyasu F. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc. 2012 Apr;75(4):870-6. doi: 10.1016/j.gie.2011.10.020. Epub 2012 Jan 31.
citation: Teoh AY, Binmoeller KF, Lau JY. Single-step EUS-guided puncture and delivery of a lumen-apposing stent for gallbladder drainage using a novel cautery-tipped stent delivery system. Gastrointest Endosc. 2014 Dec;80(6):1171. doi: 10.1016/j.gie.2014.03.038. Epub 2014 May 13. No abstract available.
citation: Teoh AYB, Kitano M, Itoi T, Perez-Miranda M, Ogura T, Chan SM, Serna-Higuera C, Omoto S, Torres-Yuste R, Tsuichiya T, Wong KT, Leung CH, Chiu PWY, Ng EKW, Lau JYW. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1). Gut. 2020 Jun;69(6):1085-1091. doi: 10.1136/gutjnl-2019-319996. Epub 2020 Mar 12.