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NCT Number: NCT02212717

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

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.

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chinese University of Hong Kong, Hong Kong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS-guided gallbladder drainage (EGBD)

Procedure

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)

Procedure

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.

Primary outcomes

  1. Overall morbidities

    Time frame: 1 years

Secondary outcomes

  1. Technical success

    Time frame: 30 days

    Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent.

  2. Pain scores

    Time frame: 7 days

    Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.

  3. Analgesic requirements

    Time frame: 7 days

    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.

  4. Stone clearance rates

    Time frame: 1 years

    The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography

  5. Clinical success

    Time frame: 30 days

    Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts.

  6. Reintervention rate

    Time frame: 1 year

    The number of patients requiring biliary related re-interventions within 1 year

  7. Re-admission rate

    Time frame: 1 year

    The number of patients requiring hospital re-admissions due to biliary related events

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • American Society for Gastrointestinal Endoscopy
  • Kinki University
  • Tokyo Medical University
  • University of Barcelona

Registry information

Official study 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.

Acronym: DRAC

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Aug 8, 2014
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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