Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients

NCT ID: NCT01146743

Last Updated: 2011-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-03-31

Brief Summary

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The investigators would like to conduct a prospective, randomized non-inferiority study to compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients.

Detailed Description

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The primary outcome is to compare clinical resolution rate of EUS-guided gallbladder drainage versus percutaneous transhepatic gallbladder drainage in acute cholecystitis patients with high risk.

The secondary outcome is to compare complications, conversion rate to open cholecystectomy during laparoscopic cholecystectomy.

Conditions

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Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EUS-guided

EUS-guided gallbladder drainage in acute cholecystitis with high risk patients

Group Type ACTIVE_COMPARATOR

EUS-guided gallbladder drainage

Intervention Type PROCEDURE

EUS-guided gallbladder drainage was performed with a linear-array echoendoscope. The initial puncture was performed at the antrum of the stomach or bulb of the duodenum and was chosen to access the gallbladder body or neck and avoid visible vessels. After removal of the needle, a 6F or 7F bougie were inserted and then removed to dilate the tract. Afterward, nasobiliary drainage tube or stent was placed.

percutaneous transhepatic

percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients

Group Type ACTIVE_COMPARATOR

percutaneous transhepatic gallbladder drainage

Intervention Type PROCEDURE

Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.

Interventions

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EUS-guided gallbladder drainage

EUS-guided gallbladder drainage was performed with a linear-array echoendoscope. The initial puncture was performed at the antrum of the stomach or bulb of the duodenum and was chosen to access the gallbladder body or neck and avoid visible vessels. After removal of the needle, a 6F or 7F bougie were inserted and then removed to dilate the tract. Afterward, nasobiliary drainage tube or stent was placed.

Intervention Type PROCEDURE

percutaneous transhepatic gallbladder drainage

Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.

Intervention Type PROCEDURE

Other Intervention Names

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EUS-guided transmural drainage percutaneous cholecystostomy

Eligibility Criteria

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Inclusion Criteria

* high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)

Exclusion Criteria

* Age below 18 years
* Pregnancy
* When the risks of endoscopy to patient are judged to outweigh the most favorable benefits of the procedure.
* Unstable or unwilling to comply with follow-up
* When a perforated viscus is known or suspected
* Simultaneously participating in another investigational drug or device study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Asan Medical Center

Principal Investigators

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SangSoo Lee, M.D.

Role: STUDY_DIRECTOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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)

Other Identifiers

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EUS_GB1

Identifier Type: -

Identifier Source: org_study_id

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