Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476054
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-14
Brief Title:
Optimal Timing for Laparoscopic Cholecystectomy After Cholecystostomy in Acute Cholecystitis Tokyo IIIII Setting
Sponsor:
Hospital Arnau de Vilanova
Organization:
Hospital Arnau de Vilanova
Study Overview
Official Title:
Optimal Timing for Laparoscopic Cholecystectomy After Percutaneous Cholecystostomy in Acute Cholecystitis Tokyo IIIII Setting A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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 drainage in acute cholecystitis has been recommended by the recent update of the Tokyo Guidelines for patients with grade II and III disease who are unable to undergo surgical treatment due to their condition or associated comorbidities
There are no reports providing high-quality scientific evidence on the optimal timing for surgery after percutaneous transhepatic gallbladder drainage so a consensus has not been reached The grade III stage generates the most controversy after percutaneous drainage delaying the cholecystectomy can lead to new episodes of exacerbation during the waiting period or may limit the procedure to a specific group of patients with this pathology
The economic impact including the number of readmissions increased length of stay and associated morbidity and mortality generates controversy regarding the subsequent therapeutic decisions after the medical management of cholecystitis in this special group of patients
There are no reports providing high-quality scientific evidence on the optimal timing for surgery after percutaneous transhepatic gallbladder drainage so a consensus has not been reached The grade III stage generates the most controversy after percutaneous drainage delaying the cholecystectomy can lead to new episodes of exacerbation during the waiting period or may limit the procedure to a specific group of patients with this pathology
The economic impact including the number of readmissions increased length of stay and associated morbidity and mortality generates controversy regarding the subsequent therapeutic decisions after the medical management of cholecystitis in this special group of patients
Detailed Description:
A multicentric blinded parallel clinical trial is proposed to compare early and late cholecystectomy after percutaneous cholecystostomy PC
The primary objective of the present study is to determine the ideal time interval-early versus late-for performing laparoscopic cholecystectomy LC in patients who underwent PC This includes assessing whether recurrence can be reduced As a secondary aim to analyze the morbidity and mortality associated with the intervention
Recruitment and Deadlines
Only surgical departments with an adequate number of patients will be included in the trial to ensure the sample size objective The selected recruitment period is 18 months
Study Variables
Surgical sheets laboratory reports daily notes made by hospital staff discharge summaries and outpatient clinic notes will be reviewed Pre-operative characteristics including sex age body mass index BMI comorbidities diabetes mellitus asthma chronic obstructive pulmonary disease malignant neoplasms and immunosuppressive therapy the main procedure performed as well as secondary procedures such as endoscopic retrograde cholangiopancreatography ERCP after confirming choledocholithiasis with magnetic resonance cholangiopancreatography MRCP will be collected Variables related to the pre-operative context of the patient such as Intensive Care Unit ICU admission the patients hemodynamic status the presence of septic shock and the need for vasoactive drugs will also be collected The characteristics studied for laparoscopic cholecystectomy LC were as follows type of prophylactic antibiotics used details of the LC surgical technique intraoperative complications assessment of technical difficulty as there are no quantitative scales relied on previous studies adapted according to our groups consensus defined as 1 Need for conversion 2 Atypical cholecystectomy eg subtotal 3 Strong adhesions on the gallbladder 4 Difficult dissection of the hilar region due to chronic inflammatory processes and 5 Increased average surgery time Postoperative characteristics recorded included hospital stay postoperative complications and treatments bile cultures subsequent complications need for reoperation 30 and 90-day morbidity and mortality and total follow-up time
Interventions
Pre-operative Study
All participants with PC will undergo a preoperative study using MRCP or endoscopic ultrasound EUS to rule out associated choledocholithiasis A second MRCP or EUS will be planned for the delayed group just before LC If choledocholithiasis is confirmed preoperative endoscopic retrograde cholangiopancreatography ERCP will be performed
Prophylactic Pre-operative Antibiotherapy
Prophylactic antibiotherapy will be administered according to hospital protocol
PC Catheter Removal
Various publications have proposed the removal of the PC catheter after confirming the clinical resolution of acute cholecystitis AC following PC performing percutaneous cholangiography between the third and fourth day of the procedure to evaluate the patency of the cystic duct If continuity is confirmed the catheter will be removed after the completion of antibiotic treatment and 24 hours before clinical discharge otherwise it will remain until the surgical intervention In the present study to avoid biases related to the catheters permanence between groups or complications associated with its removal the catheter will remain until the day of LC and its removal will be performed intraoperatively under direct vision The tip of the PC catheter will be sent for culture
Randomization and Blinding
Prior to inclusion in the trial the certified investigator from the Surgical Department will perform the screening and gather patient information and informed consent An online tool will be provided to generate the sequence for group assignment stratified by the grade of AC at the time of PC placement
According to the interval for surgical intervention
Early LC group Less than 2 weeks within the first 2 weeks of diagnosis after confirming CA resolution or improvement of functional status and coagulation that allows LC to be performed under optimal conditions preferably within the first 10 days from the onset of CA symptoms
Delayed LC group From the 6th week preferably between the 6th and 8th weeks of CA diagnosis
Randomization sheets will be kept outside the patients medical records The primary objective reduction of recurrence - in a previous study of the group it is up to 20 - with this data and assuming a reduction from 20 to 5 for those cannot be operated 73 patients per group will be needed will be clinically evaluated by a local group member who will not be part of the surgical team performing the intervention nor will have access to the randomization results to maintain blinding In case of risk to the patients included in the study access to randomization data will be allowed to the local investigator
The primary objective of the present study is to determine the ideal time interval-early versus late-for performing laparoscopic cholecystectomy LC in patients who underwent PC This includes assessing whether recurrence can be reduced As a secondary aim to analyze the morbidity and mortality associated with the intervention
Recruitment and Deadlines
Only surgical departments with an adequate number of patients will be included in the trial to ensure the sample size objective The selected recruitment period is 18 months
Study Variables
Surgical sheets laboratory reports daily notes made by hospital staff discharge summaries and outpatient clinic notes will be reviewed Pre-operative characteristics including sex age body mass index BMI comorbidities diabetes mellitus asthma chronic obstructive pulmonary disease malignant neoplasms and immunosuppressive therapy the main procedure performed as well as secondary procedures such as endoscopic retrograde cholangiopancreatography ERCP after confirming choledocholithiasis with magnetic resonance cholangiopancreatography MRCP will be collected Variables related to the pre-operative context of the patient such as Intensive Care Unit ICU admission the patients hemodynamic status the presence of septic shock and the need for vasoactive drugs will also be collected The characteristics studied for laparoscopic cholecystectomy LC were as follows type of prophylactic antibiotics used details of the LC surgical technique intraoperative complications assessment of technical difficulty as there are no quantitative scales relied on previous studies adapted according to our groups consensus defined as 1 Need for conversion 2 Atypical cholecystectomy eg subtotal 3 Strong adhesions on the gallbladder 4 Difficult dissection of the hilar region due to chronic inflammatory processes and 5 Increased average surgery time Postoperative characteristics recorded included hospital stay postoperative complications and treatments bile cultures subsequent complications need for reoperation 30 and 90-day morbidity and mortality and total follow-up time
Interventions
Pre-operative Study
All participants with PC will undergo a preoperative study using MRCP or endoscopic ultrasound EUS to rule out associated choledocholithiasis A second MRCP or EUS will be planned for the delayed group just before LC If choledocholithiasis is confirmed preoperative endoscopic retrograde cholangiopancreatography ERCP will be performed
Prophylactic Pre-operative Antibiotherapy
Prophylactic antibiotherapy will be administered according to hospital protocol
PC Catheter Removal
Various publications have proposed the removal of the PC catheter after confirming the clinical resolution of acute cholecystitis AC following PC performing percutaneous cholangiography between the third and fourth day of the procedure to evaluate the patency of the cystic duct If continuity is confirmed the catheter will be removed after the completion of antibiotic treatment and 24 hours before clinical discharge otherwise it will remain until the surgical intervention In the present study to avoid biases related to the catheters permanence between groups or complications associated with its removal the catheter will remain until the day of LC and its removal will be performed intraoperatively under direct vision The tip of the PC catheter will be sent for culture
Randomization and Blinding
Prior to inclusion in the trial the certified investigator from the Surgical Department will perform the screening and gather patient information and informed consent An online tool will be provided to generate the sequence for group assignment stratified by the grade of AC at the time of PC placement
According to the interval for surgical intervention
Early LC group Less than 2 weeks within the first 2 weeks of diagnosis after confirming CA resolution or improvement of functional status and coagulation that allows LC to be performed under optimal conditions preferably within the first 10 days from the onset of CA symptoms
Delayed LC group From the 6th week preferably between the 6th and 8th weeks of CA diagnosis
Randomization sheets will be kept outside the patients medical records The primary objective reduction of recurrence - in a previous study of the group it is up to 20 - with this data and assuming a reduction from 20 to 5 for those cannot be operated 73 patients per group will be needed will be clinically evaluated by a local group member who will not be part of the surgical team performing the intervention nor will have access to the randomization results to maintain blinding In case of risk to the patients included in the study access to randomization data will be allowed to the local investigator
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