Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis.

Acute Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153031
• Other study ID #: 11/2021
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: November 1, 2021

Study information

• Verified date: December 2021
• Source: Hospital General Universitario de Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: November 1, 2021
• Est. primary completion date: February 28, 2021
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Other:
• lithiasic
Cholelithiasis is the presence of one or more calculi (gallstones) in the gallbladder.

Procedure:
• Emergency surgery
Emergency cholecystectomy
• cholecystectomy
cholecystectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario de Alicante

References & Publications (9)

Agha R, Abdall-Razak A, Crossley E, Dowlut N, Iosifidis C, Mathew G; STROCSS Group. STROCSS 2019 Guideline: Strengthening the reporting of cohort studies in surgery. Int J Surg. 2019 Dec;72:156-165. doi: 10.1016/j.ijsu.2019.11.002. Epub 2019 Nov 6. — View Citation

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. — View Citation

Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992 May;111(5):518-26. — View Citation

Doyle DJ, Goyal A, Bansal P, Garmon EH. American Society of Anesthesiologists Classification. 2021 Oct 9. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/ — View Citation

Gulaya K, Desai SS, Sato K. Percutaneous Cholecystostomy: Evidence-Based Current Clinical Practice. Semin Intervent Radiol. 2016 Dec;33(4):291-296. Review. — View Citation

Miura F, Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gouma DJ, Garden OJ, Büchler MW, Yoshida M, Mayumi T, Okamoto K, Gomi H, Kusachi S, Kiriyama S, Yokoe M, Kimura Y, Higuchi R, Yamashita Y, Windsor JA, Tsuyuguchi T, Gabata T, Itoi T, Hata J, Liau KH; Tokyo Guidelines Revision Comittee. TG13 flowchart for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):47-54. doi: 10.1007/s00534-012-0563-1. — View Citation

Pisano M, Allievi N, Gurusamy K, Borzellino G, Cimbanassi S, Boerna D, Coccolini F, Tufo A, Di Martino M, Leung J, Sartelli M, Ceresoli M, Maier RV, Poiasina E, De Angelis N, Magnone S, Fugazzola P, Paolillo C, Coimbra R, Di Saverio S, De Simone B, Weber DG, Sakakushev BE, Lucianetti A, Kirkpatrick AW, Fraga GP, Wani I, Biffl WL, Chiara O, Abu-Zidan F, Moore EE, Leppäniemi A, Kluger Y, Catena F, Ansaloni L. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020 Nov 5;15(1):61. doi: 10.1186/s13017-020-00336-x. Review. — View Citation

Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Giménez ME, de Santibañes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9. Review. — View Citation

Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Garden OJ, Kiriyama S, Hata J, Gabata T, Yoshida M, Miura F, Okamoto K, Tsuyuguchi T, Itoi T, Yamashita Y, Dervenis C, Chan AC, Lau WY, Supe AN, Belli G, Hilvano SC, Liau KH, Kim MH, Kim SW, Ker CG; Tokyo Guidelines Revision Committee. TG13 diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):35-46. doi: 10.1007/s00534-012-0568-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	global successful rate	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	through study completion, an average of 1.5 year
Primary	90-days mortality		90 days
Primary	complications rate		through study completion, an average of 1.5 year
Secondary	total length of hospitalization during acute episode		through study completion, an average of 1.5 year
Secondary	drainage duration		through study completion, an average of 1.5 year
Secondary	1-year readmission rate due to biliary complications		1 year
Secondary	The degree of adherence to treatment algorithm of the Tokyo Guidelines 13/18 in the indication of PC		through study completion, an average of 1.5 year
Secondary	cholecystectomy rate		through study completion, an average of 1.5 year