Bile Aspiration Vs Drain in Acute Cholecystitis

Not Applicable

Not yet recruiting

• Conditions: Cholecystitis, Acute
• Interventions: Procedure: Cholecystostomy; Procedure: Gallbladder aspiration

• Registration Number: NCT03012243
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03
• Study Start: 2025-03-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Acute cholecystitis, not warranting acute cholecystectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecystostomy	Cholecystostomy	Percutaneous cholecystostomy, leaving drain in situ
Gallbladder aspiration	Gallbladder aspiration	Gallblader aspiration without drain

Primary Outcome Measures

Name	Time	Method
Amount of morphine administrated	24 hours	The total amount of morphine required to relieve the pain the first 24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska University Hospital, Center for Digestive Diseases; 🇸🇪 Stockholm, Sweden