Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05153031
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2021-11-07
Brief Title:
Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis
Sponsor:
Hospital General Universitario de Alicante
Organization:
Hospital General Universitario de Alicante
Study Overview
Official Title:
Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis A Retrospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 surgerygeneral anesthesia The investigators conduct a retrospective observational study Period 2016-2021 Inclusion criteria Patients treated with PC for AC Tokyo guidelines TG1318 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
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 surgerygeneral 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 perforationperitonitis or perivesical abscess Each patient was classified according to the TG1318 severity scale Grade I mild Grade II moderate or Grade III severe The degree of adherence to the TG1318 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 andor 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 Calots 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
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 perforationperitonitis or perivesical abscess Each patient was classified according to the TG1318 severity scale Grade I mild Grade II moderate or Grade III severe The degree of adherence to the TG1318 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 andor 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 Calots 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None