Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis.

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Brief Title

Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis.

Official Title

Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis: A Retrospective Cohort Study.

Brief Summary

      Percutaneous cholecystostomy (PC) is an increasingly performed procedure for acute
      cholecystitis (AC), safe and less invasive than laparoscopic cholecystectomy, very useful in
      selected patients (severe comorbidities, not suitable for surgery/general anesthesia,..) The
      investigators conduct a retrospective observational study. Period: 2016-2021. Inclusion
      criteria: Patients treated with PC for AC. Tokyo guidelines TG13/18 the investigators
      algorithm to treat AC.

      The characteristics of the sample undergoing Percutaneous Cholecystostomy, main indications,
      evolution and clinical results were reported in an initial observational study. Subsequently,
      a retrospective analytical study was designed to compare various cohorts: lithiasic vs
      alithiasic Acute Cholecystitis, elective vs emergency surgery or management with PC alone.
    

Detailed Description

      Laparoscopic cholecystectomy (LC) is the gold standard for the treatment of acute
      cholecystitis (AC). Percutaneous cholecystostomy (PC) is an increasingly performed procedure
      for AC, safe and less invasive than LC, very useful in selected patients (severe
      comorbidities, not suitable for surgery/general anesthesia,..).

      The theoretical advantages offered by PC are the rapid resolution of sepsis and the optimal
      preparation of the patient for elective LC . Its main drawback is the possibility of
      recurrence of AC or other biliary events while awaiting LC.

      Thus, many questions about PC remain unanswered: how should the catheter be handled and
      removed? When is the best time to perform LC? Should cholecystectomy be offered to all
      patients after PC? Does PC complicate subsequent cholecystectomy? How good is the adherence
      to the Tokyo Guidelines in real life? To answer these questions, the investigators devised
      the present study involving patients undergoing PC at the investigators center.

      The inclusion criteria were: patients undergoing PC diagnosed with AC following the TG13 and
      TG18 diagnostic criteria. The exclusion criteria were: patients undergoing PC for causes
      other than AC, such as neoplasms, bile duct alterations or non-therapeutic diagnostic
      purposes; patients who had previously undergone endoscopic drainage.

      The characteristics of the sample undergoing PC, main indications, evolution and clinical
      results were reported in an initial observational study. Subsequently, a retrospective
      analytical study was designed to compare various cohorts: lithiasic vs alithiasic AC,
      elective vs emergency surgery or management with PC alone. Patients' main characteristics,
      associated morbidity (complications according to Clavien-Dindo grade (CD) and 90-day
      mortality, need for new drain placement, and surgical approach (laparoscopic vs. open) were
      compared, following the STROCSS 2019 guidelines.

      Variables were compiled from a review of the digitized medical histories which included one
      year of follow-up. The demographic variables studied were age and sex. Functional status was
      assessed according to the ASA scale and comorbidity using the Charlson Comorbidity Index
      (CCI). The type of radiological test used in the diagnosis (ultrasound, computed tomography
      (CT), nuclear magnetic resonance, cholangioresonance or a combination of these) and
      laboratory tests (C-reactive protein and leukocyte count) were recorded. Marked local
      inflammation was defined as gangrenous or emphysematous AC, biliary perforation/peritonitis,
      or perivesical abscess. Each patient was classified according to the TG13/18 severity scale:
      Grade I (mild), Grade II (moderate) or Grade III (severe). The degree of adherence to the
      TG13/18 was taken into account in the indication of PC.

      The main indications for PC, total length of hospitalization, time from admission to drainage
      placement, and drainage duration in days were recorded. The procedure was considered
      successful when the patient did not require a new drain or emergency surgery, did not die due
      to the infection, and could be discharged from hospital after PC removal. Even though PC is
      not a surgical intervention, the Clavien-Dindo complication scale was used.

      The patients who underwent cholecystectomy and those placed on the surgical waiting list were
      recorded, as was the type of surgery (emergency vs elective). In the case of emergency
      surgery the reason for the intervention was also reported. Approach, conversion rate to open
      surgery, total length of hospitalization, time from PC to cholecystectomy (in days), and
      finally complications according to the Clavien-Dindo classification were assessed. Ninety-day
      mortality rates of patients both after PC and after cholecystectomy were recorded, as well as
      the causes. As regards clinical evolution, readmission rates for biliary causes (AC, biliary
      colic, choledocholithiasis, cholangitis and/or pancreatitis) and other causes were reported,
      along with time until readmission and main reason.

      After the general assessment (physical examination, complementary tests and clinical status)
      the surgical team decided whether to proceed with PC or perform emergency surgery. The PC was
      placed by interventional radiologists. The technique was performed under local anesthesia in
      aseptic conditions, guided by ultrasound or CT. Ultrasound-guided transhepatic PC using the
      Seldinger technique was the usual procedure. Prior to removal, a cholangiography was
      performed through the catheter in order to check its patency and the passage of the contrast
      into the duodenum. In some cases, the drain was closed for 24-48 hours to assess tolerance
      before removal.

      Emergency cholecystectomy was performed by the oncall surgical team. If a laparoscopic
      approach was chosen, it was carried out using the French technique, with dissection of
      Calot's triangle until the Strasberg critical view of safety was achieved. If an open
      approach was selected or if conversion from laparoscopic surgery proved necessary, it was
      carried out via right subcostal laparotomy.
    


Study Type

Observational


Primary Outcome

global successful rate

Secondary Outcome

 total length of hospitalization during acute episode

Condition

Acute Cholecystitis

Intervention

lithiasic

Study Arms / Comparison Groups

 lithiasic acute cholecystitis
Description:  Acute cholecystitis with the presence of one or more calculi (gallstones) in the gallbladder.

Publications

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

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

195

Start Date

January 1, 2016

Completion Date

November 1, 2021

Primary Completion Date

February 28, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic
             criteria

        Exclusion Criteria:

          -  Patients undergoing PC for causes other than AC, such as neoplasms, bile duct
             alterations or non-therapeutic diagnostic purposes;

          -  Patients who had previously undergone endoscopic drainage.
      

Gender

All

Ages

17 Years - N/A


Contacts

, , 



Administrative Informations


NCT ID

NCT05153031

Organization ID

11/2021


Responsible Party

Principal Investigator

Study Sponsor

Hospital General Universitario de Alicante


Study Sponsor

, , 


Verification Date

December 2021