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Bile Aspiration vs Drain in Acute Cholecystitis

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ClinicalTrials.gov Identifier: NCT03012243
Recruitment Status : Not yet recruiting
First Posted : January 6, 2017
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Gabriel Sandblom, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Cholecystitis, Acute Procedure: Gallbladder aspiration Procedure: Cholecystostomy Not Applicable

Detailed Description:

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 alternative that may be more convenient than percutaneous cholecystostomy. The aspiration is performed with a small gauge needle under ultrasound guidance without leaving a drain. The aspiration leads to a decompression of the gallbladder, which facilitates recovery. However, it has only been described in a few studies and need more evaluation.

One single aspiration may be sufficient to relief symptoms for the majority of patients, but if two aspirations are performed the success rate increases substantially. One randomized controlled trial has been presented where PC is compared to gallbladder aspiration. In this trial PC was superior to gallbladder aspiration in terms of effectiveness. In this trail, however, only one aspiration was performed. No major complications occurred in either group and minor complications were equal between the groups. In a retrospective study comparing aspiration with PC it was found that gallbladder aspiration is safer than PC and has a comparable clinical outcome.

It is believed that single decompressions are sufficient for reduction of the intraluminal pressure. Only a minority of patients have positive bile cultures which, indicates that infection is not a key mechanism in development of cholecystitis, which indicates that a continuous drainage may not be necessary. As lower rates of complications are reported for aspiration due to usage of smaller needle and no drain left that can dislocate and cause bile leakage which is feared complication of PC. It is suggested that PC can have a role as a salvage method when aspiration is not successful.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Bile Aspiration vs Drain in Acute Cholecystitis
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cholecystostomy
Percutaneous cholecystostomy, leaving drain in situ
Procedure: Cholecystostomy
Ultrasound-guided insertion of drain in the gallbladder. The drain is left in the gallbladder until clinical assessment and laboratory analyses show that the acute cholecystitis has been successfully treated.
Other Name: Percutaneous intervention

Experimental: Gallbladder aspiration
Gallblader aspiration without drain
Procedure: Gallbladder aspiration
Percutaneous ultrasound-guided aspiration of bile from the gallbladder. This is performed without leaving a drain in the gallbladder. The aspiration is performed with the intention to relief the pressure in the gallbladder, without drain.
Other Name: Percutaneous intervention




Primary Outcome Measures :
  1. Morphine intake [ Time Frame: 24 hours ]
    Need of analgesia after intervention


Secondary Outcome Measures :
  1. Pain [ Time Frame: 5 days ]
    Pain estimated on Visual Analogue Scale

  2. Nausea [ Time Frame: 5 days ]
    Nausea estimated with a Likert scale

  3. Re-intervention [ Time Frame: 5 days ]
    Repeated percutaneous aspiration of adjustment of drain

  4. Body temperature [ Time Frame: 5 days ]
    Temperature measured daily

  5. CRP [ Time Frame: 5 days ]
    Daily measures of C-reactive protein

  6. LPK [ Time Frame: 5 days ]
    Daily measures of Leukocyte particle Concentration

  7. Time to discharge [ Time Frame: 30 days ]
    Time from intervention to discharge from the hospital

  8. Complications [ Time Frame: 30 days ]
    Procedure-related complications



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute cholecystitis, not warranting acute cholecystectomy

Exclusion Criteria:

  • Indication for acute cholecystectomy, i.e. history < 5 days and no contraindication to surgery
  • Liver cirrhosis
  • Ascites
  • Emphysematous cholecystitis
  • Gallbladder perforation
  • Suspected malignant condition
  • Portal Hypertension
  • Biliary pancreatitis
  • Common bile duct stones

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012243


Contacts
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Contact: Agnieszka Popowicz, MD +46 73 582 62 13 a.e.popowicz@gmail.com
Contact: Gabriel Sandblom, Assoc Prof +46 70 415 82 18 gabriel.sandblom@ki.se

Locations
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Sweden
Karolinska University Hospital, Center for Digestive Diseases
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Gabriel Sandblom, Assoc Prof Karolinska Institutet

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Responsible Party: Gabriel Sandblom, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03012243     History of Changes
Other Study ID Numbers: Bile aspiration vs drain trial
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases