A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.

Acute Cholecystitis Clinical Trial

— DRAC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212717
• Other study ID #: CREC-2014.301-T
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2014
• Est. completion date: March 2019

Study information

• Verified date: July 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• EUS-guided gallbladder drainage (EGBD)
The gallbladder would be identified by a linear echoendoscope (EUS) and a suitable puncture site in the stomach or the duodenum without intervening blood vessels would be located. The gallbladder would be punctured with a 19-gauge needle and a guidewire would be passed through the needle and looped in the gallbladder. The Hot AXIOS stent would then be inserted. A naso-gallbladder drain or a 5-7Fr double pigtail stents can be inserted into gallbladder if the effluent failed to clear after irrigation. This would be performed to improve drainage and avoid obstruction of the stent.
• Percutaneous cholecystostomy (PC)
Trained interventional radiologists in the respective hospitals would perform the procedure under local anesthesia. A transhepatic route would be used in all patients to decrease bile leakage. An 8.5 Fr pigtail drainage catheter would be placed between the 8th or 9th intercostal space under sonographic and fluoroscopic guidance. The pigtail catheter would be drained to a bedside bag.

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong	Hong Kong
Japan	Kinki University Hospital	Osaka
Japan	Tokyo Medical University Hospital	Tokyo
Spain	University Hospital Rio Hortega	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	American Society for Gastrointestinal Endoscopy, Kinki University, Tokyo Medical University, University of Barcelona

Countries where clinical trial is conducted

China,  Japan,  Spain, 

References & Publications (3)

de la Serna-Higuera C, Pérez-Miranda M, Gil-Simón P, Ruiz-Zorrilla R, Diez-Redondo P, Alcaide N, Sancho-del Val L, Nuñez-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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall morbidities		1 years
Secondary	Technical success	Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent.	30 days
Secondary	Pain scores	Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.	7 days
Secondary	Analgesic requirements	The amount of analgesic consumed during admission will be recorded and compared between groups. Oral panadol and intravenous tramadol (or equivalent) would be provided as required to patients.	7 days
Secondary	Stone clearance rates	The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography	1 years
Secondary	Clinical success	Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts.	30 days
Secondary	Reintervention rate	The number of patients requiring biliary related re-interventions within 1 year	1 year
Secondary	Re-admission rate	The number of patients requiring hospital re-admissions due to biliary related events	1 year