Bile Aspiration vs Drain in Acute Cholecystitis

Brief Title

Bile Aspiration vs Drain in Acute Cholecystitis

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 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.
    

Study Type

Interventional

Primary Outcome

Amount of morphine administrated

Secondary Outcome

 Pain

Condition

Cholecystitis, Acute

Intervention

Gallbladder aspiration

Study Arms / Comparison Groups

 Cholecystostomy

Description:  Percutaneous cholecystostomy, leaving drain in situ

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

40

Start Date

August 1, 2021

Completion Date

August 31, 2023

Primary Completion Date

December 31, 2022

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gabriel Sandblom, Assoc Prof, +46 73 582 62 13, [email protected]

Location Countries

Sweden

Location Countries

Sweden

NCT ID

NCT03012243

Organization ID

Bile aspiration vs drain trial

Responsible Party

Principal Investigator

Study Sponsor

Karolinska Institutet

Study Sponsor

Gabriel Sandblom, Assoc Prof, Principal Investigator, Karolinska Institutet

Verification Date

February 2021