Clinical Trial: Bile Aspiration vs Drain in Acute Cholecystitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Randomized Controlled Trial of Bile Aspiration vs Drain in Acute Cholecystitis

Brief Summary: In order to compare percutaneous cholecystostomy and leaving a drain in situ with percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled trial.

Detailed Summary:

Percutaneous cholecystostomy is a minimally invasive technique for treatment of cholecystitis. The cholecystostomy can be inserted transhepatically or transabdominally. The transhepatic route is preferred due to lower risk for bile leakage. The drainage decompresses the gallbladder and drains the bile. This decompression reduces the inflammatory process in the gallbladder. Percutaneous cholecystostomy is often applied in patients not fit for emergency surgery who are in need of intervention due to deterioration of their clinical status. However, even though cholecystostomy is widely practised, it is not fully evaluated.

Percutaneous cholecystostomy has a high success rate, a low procedure-related mortality but a 30 day mortality of 15%. Furthermore, recurrence rates within one year after a cholecystostomy are reported to range between 4 to 22%.

The time duration of the drainage differ between different studies and range from three to six weeks. Optimal timing for drainage has not been studied. Two weeks seem to be sufficient for a maturation of the tract for the transhepatic route and 3 weeks for the transabdominal route. It has been suggested that a prolonged drainage duration is associated with increased risk for recurrence of inflammation due to local irritation of the gallbladder mucosa by the drain.

Percutaneous cholecystostomy is often considered as a bridge to surgery. However, less than half of patients treated with PC are treated with cholecystectomy. This suggests that this treatment is often chosen in a group not fit for surgery and often turns out to be a definitive treatment.

Percutaneous gallbladder aspiration is a technique used for purposes similar to percutaneous cholecystostomy. This technique is an alterna
Sponsor: Karolinska Institutet

Current Primary Outcome: Morphine intake [ Time Frame: 24 hours ]

Need of analgesia after intervention


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain [ Time Frame: 5 days ]
    Pain estimated on Visual Analogue Scale
  • Nausea [ Time Frame: 5 days ]
    Nausea estimated with a Likert scale
  • Re-intervention [ Time Frame: 5 days ]
    Repeated percutaneous aspiration of adjustment of drain
  • Body temperature [ Time Frame: 5 days ]
    Temperature measured daily
  • CRP [ Time Frame: 5 days ]
    Daily measures of C-reactive protein
  • LPK [ Time Frame: 5 days ]
    Daily measures of Leukocyte particle Concentration
  • Time to discharge [ Time Frame: 30 days ]
    Time from intervention to discharge from the hospital
  • Complications [ Time Frame: 30 days ]
    Procedure-related complications


Original Secondary Outcome:

  • Pain [ Time Frame: 5 days ]
    Pain estimated on Visual Analogue Scale
  • Nausea [ Time Frame: 5 days ]
    Nausea estimated with a Likert scale
  • Re-intervention [ Time Frame: 5 days ]
    Repeated percutaneous aspiration of adjustment of drain
  • Body temperature [ Time Frame: 5 days ]
  • CRP [ Time Frame: 5 days ]
    Daily measures of C-reactive protein
  • LPK [ Time Frame: 5 days ]
    Daily measures of Leukocyte particle Concentration
  • Time to discharge [ Time Frame: 30 days ]
  • Complications [ Time Frame: 30 days ]
    Procedure-related complications


Information By: Karolinska Institutet

Dates:
Date Received: January 4, 2017
Date Started: July 1, 2017
Date Completion: September 2019
Last Updated: May 12, 2017
Last Verified: May 2017