Acute cholecystitis - Clinical trial details 

Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis: a prospective feasibility study

Recruitment status:
Recruiting
Primary Sponsor:
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Recruitment countries:
Japan
Health condition studied:
Acute cholecystitis
URL:
Link to the clinical trial website

About the trial

Interventions:
Endoscopic ultrasound-guided gallbladder drainage
Key inclusion and exclusion criteria:
  • Inclusion criteria: 1)Acute cholecystitis
    2)Moderate or mild cholecystitis which was not relieved with conservative therapy.
    3)Performance Status 0-3.
    4)Age >20
    5)Written informed consent was obtained.
  • Exclusion criteria: 1)Severe cholecystitis
    2)Cholangititis with choledocholithiasis
    3)Post-gastrectomy(B-II or Roux-en-Y anastomosis)
    4)Cardiovascular or respiratory decompensation
    5)Severe renal dysfunction
    6)With steroid therapy
    7)Severe ascites
    8)Severe bleeding diathesis
    9)JCS >1-1
    10)Severe heart disease
    11)Severe pulmonary disease
    12)Pregnant womman
    13)Inappropriate patient
  • Age minimum:  20years-old
  • Age maximum:  Not applicable
  • Gender:  Male and Female
Primary outcomes:
Technical success rate, Clinical success rate
Secondary outcomes:
Complications
Target sample size:
20
Study type:
Interventional
Study design:
Single arm Non-randomized
Contacts:
  • Name:  
  • Address:  7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
  • Phone: 
  • Email:  kkawakubo-gi@umin.ac.jp
  • Affiliation:  Graduate School of Medicine, The University of Tokyo Department of Gastroenterology
  • Name: Kazumichi Kawakubo 
  • Address:  7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
  • Phone:  kkawakubo-gi@umin.ac.jp
  • Email:  kkawakubo-gi@umin.ac.jp
  • Affiliation:  Graduate School of Medicine, The University of Tokyo Department of Gastroenterology

Technical details

Scientific title:
Sources of monetary support:
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Secondary sponsors:
Main ID:
JPRN-UMIN000006512
Secondary ID:
Register:
JPRN
Date of registration:
10/10/2011
Date of first enrollment:
2011/10/01
Last refreshed:
3 June 2014

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