Acute CholecystitisNCT05153031
Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis.
An observational study of Acute Cholecystitis and Percutaneous Cholecystostomy, run by Hospital General Universitario de Alicante.
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… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Acute Cholecystitis, Percutaneous Cholecystostomy
- What is being tested?
- lithiasic, Emergency surgery and cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria
Who may be able to join
- Patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria
Who cannot join
- 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.
About this study
Official title: Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis: A Retrospective Cohort Study.
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.
Read the 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.
- Conditions
- Acute Cholecystitis, Percutaneous Cholecystostomy
- Being tested
- lithiasic, Emergency surgery, cholecystectomy
- Keywords
- Acute Cholecystitis, percutaneous cholecystostomy, laparoscopic cholecystectomy
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lithiasicOther
Cholelithiasis is the presence of one or more calculi (gallstones) in the gallbladder.
Emergency surgeryProcedure or surgery
Emergency cholecystectomy
cholecystectomyProcedure or surgery
cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| lithiasic acute cholecystitis | Acute cholecystitis with the presence of one or more calculi (gallstones) in the gallbladder. Receives: Other: lithiasic | |
| alithiasic acute cholecystitis | Acute cholecystitis without the presence of one or more calculi (gallstones) in the gallbladder. | |
| elective cholecystectomy | Elective surgery is surgery that is scheduled in advance because it does not involve a medical emergency. | |
| emergency cholecystectomy | Emergence surgery Receives: Procedure: Emergency surgery | |
| management with percutaneous cholecystostomy alone | Patients that didnt recieve cholecystectomy during de whole study | |
| managemente with surgery | Patients that recieve cholecystectomy during de whole study Receives: Procedure: cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1.5 year
90-days mortality
Measured: 90 days
complications rate
Measured: through study completion, an average of 1.5 year
Secondary outcomes (5)
total length of hospitalization during acute episode
Measured: through study completion, an average of 1.5 year
drainage duration
Measured: through study completion, an average of 1.5 year
1-year readmission rate due to biliary complications
Measured: 1 year
The degree of adherence to treatment algorithm of the Tokyo Guidelines 13/18 in the indication of PC
Measured: through study completion, an average of 1.5 year
cholecystectomy rate
Measured: through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Jan 2016
- Primary completion28 Feb 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candido Fernando Alcazar-Lopez, Hospital General Universitario de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153031
- Sponsor's protocol ID
- 11/2021
- Status last verified
- Dec 2021
- First submitted
- 7 Nov 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miura F, Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gouma DJ, Garden OJ, Buchler 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.
PubMed 23307003Pisano 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, Leppaniemi 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.
PubMed 33153472Gulaya K, Desai SS, Sato K. Percutaneous Cholecystostomy: Evidence-Based Current Clinical Practice. Semin Intervent Radiol. 2016 Dec;33(4):291-296. doi: 10.1055/s-0036-1592326.
PubMed 27904248Yokoe 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.
PubMed 23340953Yokoe 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, Gimenez ME, de Santibanes 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.
PubMed 29032636Agha 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.
PubMed 31704426Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/
PubMed 28722969Charlson 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. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992 May;111(5):518-26.
PubMed 1598671Rubio-Garcia JJ, Velilla Vico D, Villodre Tudela C, Irurzun Lopez J, Contreras Padilla D, Alcazar Lopez C, Carbonell Morote S, Ramia-Angel JM. Impact of percutaneous cholecystostomy in the management of acute cholecystitis: a retrospective cohort study at a tertiary center. Updates Surg. 2023 Jun;75(4):905-914. doi: 10.1007/s13304-023-01499-3. Epub 2023 Mar 29.
PubMed 36991301
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis: A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05153031
- Acronym / sponsor ID
- 11/2021
- Conditions
- Acute Cholecystitis, Percutaneous Cholecystostomy
- Keywords
- Acute Cholecystitis, percutaneous cholecystostomy, laparoscopic cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Hospital General Universitario de AlicanteUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| lithiasic acute cholecystitis | – | Other: lithiasicAcute cholecystitis with the presence of one or more calculi (gallstones) in the gallbladder. |
| alithiasic acute cholecystitis | – | –Acute cholecystitis without the presence of one or more calculi (gallstones) in the gallbladder. |
| elective cholecystectomy | – | –Elective surgery is surgery that is scheduled in advance because it does not involve a medical emergency. |
| emergency cholecystectomy | – | Procedure: Emergency surgeryEmergence surgery |
| management with percutaneous cholecystostomy alone | – | –Patients that didnt recieve cholecystectomy during de whole study |
| managemente with surgery | – | Procedure: cholecystectomyPatients that recieve cholecystectomy during de whole study |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria
Key inclusion criteria (1 listed)
- Patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lithiasicCholelithiasis is the presence of one or more calculi (gallstones) in the gallbladder. | Other | lithiasic acute cholecystitis |
| Emergency surgeryEmergency cholecystectomy | Procedure or surgery | emergency cholecystectomy |
| cholecystectomycholecystectomy | Procedure or surgery | managemente with surgery |
Primary outcome
global successful rate
Time frame: through study completion, an average of 1.5 year
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
90-days mortality
Time frame: 90 days
complications rate
Time frame: through study completion, an average of 1.5 year
5 secondary outcomes
total length of hospitalization during acute episode
Time frame: through study completion, an average of 1.5 year
drainage duration
Time frame: through study completion, an average of 1.5 year
1-year readmission rate due to biliary complications
Time frame: 1 year
The degree of adherence to treatment algorithm of the Tokyo Guidelines 13/18 in the indication of PC
Time frame: through study completion, an average of 1.5 year
cholecystectomy rate
Time frame: through study completion, an average of 1.5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Background: PubMed 23307003Miura F, Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gouma DJ, Garden OJ, Buchler 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.
- Background: PubMed 33153472Pisano 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, Leppaniemi 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.
- Background: PubMed 27904248Gulaya K, Desai SS, Sato K. Percutaneous Cholecystostomy: Evidence-Based Current Clinical Practice. Semin Intervent Radiol. 2016 Dec;33(4):291-296. doi: 10.1055/s-0036-1592326.
- Background: PubMed 23340953Yokoe 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.
- Background: PubMed 29032636Yokoe 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, Gimenez ME, de Santibanes 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.
- Background: PubMed 31704426Agha 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.
- Background: PubMed 28722969Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/
- Background: PubMed 3558716Charlson 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. doi: 10.1016/0021-9681(87)90171-8.
- Background: PubMed 1598671Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992 May;111(5):518-26.
- Derived from this study: PubMed 36991301Rubio-Garcia JJ, Velilla Vico D, Villodre Tudela C, Irurzun Lopez J, Contreras Padilla D, Alcazar Lopez C, Carbonell Morote S, Ramia-Angel JM. Impact of percutaneous cholecystostomy in the management of acute cholecystitis: a retrospective cohort study at a tertiary center. Updates Surg. 2023 Jun;75(4):905-914. doi: 10.1007/s13304-023-01499-3. Epub 2023 Mar 29.
- Individual participant dataSharing planned: No
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Cholecystitis, Acute, Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis and Percutaneous Cholecystostomy, run by Hospital General Universitario de Alicante.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global successful rate (time frame: through study completion, an average of 1.5 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05153031, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.