Clinical trial NCT03012243: Bile Aspiration Vs Drain in Acute Cholecystitis
Official title: Randomized Controlled Trial of Bile Aspiration Vs Drain in Acute Cholecystitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cholecystitis, Acute
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Amount of morphine administrated
timeFrame: 24 hours
Secondary outcomes:
measure: Pain
timeFrame: 5 days
measure: Nausea
timeFrame: 5 days
measure: Re-intervention
timeFrame: 5 days
measure: Body temperature
timeFrame: 5 days
measure: CRP
timeFrame: 5 days
measure: LPK
timeFrame: 5 days
measure: Time to discharge
timeFrame: 30 days
measure: Complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Center for Digestive Diseases
Study officials:
affiliation: Karolinska Institutet
name: Gabriel Sandblom, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: