Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06047327
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-09-14
Brief Title:
EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease A Randomized Controlled Non-inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
Liver biopsy may be indicated in various clinical scenarios to help diagnose and manage liver diseases Endoscopic ultrasound EUS liver biopsy and percutaneous USG guided liver biopsy are two methods used to obtain liver tissue samples EUS involves using an endoscope with an ultrasound probe to guide a needle through the stomach wall and into the liver while percutaneous ultrasound guided biopsy involves inserting a needle directly through the skin and into the liver using ultrasound guidance
A specimen measuring 15 mm or more and containing 6 to 8 CPTs is generally considered adequate for the histologic diagnosis of diffuse liver disease However stricter requirements of specimen length of 20 mm or longer with 11 or more CPTs for reliable grading and staging of chronic viral hepatitis have been recommended With this study we aim to study in a head-to-head comparison between EUS-guided and percutaneous PC liver biopsies with regards to tissue acquisition adequacy
A specimen measuring 15 mm or more and containing 6 to 8 CPTs is generally considered adequate for the histologic diagnosis of diffuse liver disease However stricter requirements of specimen length of 20 mm or longer with 11 or more CPTs for reliable grading and staging of chronic viral hepatitis have been recommended With this study we aim to study in a head-to-head comparison between EUS-guided and percutaneous PC liver biopsies with regards to tissue acquisition adequacy
Detailed Description:
Aim and Objective - EUS-LB with a 19G Franseen needle is non-inferior to PC-LB with a 18G BioPince Needle with regards to total specimen length and diagnostic adequacy
Hypothesis - i EUS-LB with a 19G FNB needle is non-inferior to PC-LB with a 18G full core biopsy needle with regards to total specimen length and diagnostic adequacy
ii There would be lesser procedure related pain and higher patient satisfaction with EUS-LB compared to PC-LB
Study population
1 Patients 18 years of age
2 Eligibility for deep sedation with propofol
3 Undergoing liver biopsy for diagnosisevaluationstaging
Study design All consecutive in-patients and out-patients requiring liver biopsy for evaluation of diffuse parenchymal liver disease will be evaluated for inclusion
Study period 1 year
Sample size with justification The percentage success rate of procurement of adequate liver biopsies defined by specimen length 15 mm and 8 CPTs was assumed to be 90 with PC-LB based on two recent retrospective studies comparing PC-LB with EUS-LB These studies used the bigger 16G Biopince needles Literature Bhogal N Endosc Int Open 2020 99 Facciorusso A Cancers 2021 100 With similar criteria for adequacy the success rates with EUS-LB were assumed to be 85 for non-inferiority comparison based on recent studies of EUS-LB using 19G Franseen needles Literature Hashimoto R Dig Dis Sci 2020 100 Aggarwal SN GIE 2021 972 Nallapeta N Hepatology 2021 556
With alpha-value of 10 power of 80 and non-inferiority margin of 10 we need to enroll 44 patients in each of PC-LB and EUS-LB arms for a total sample size of 88 patients We plan to enroll 90 patients in this trial to account for technical inadequacies
Intervention Patient after screening for all exclusion criteria will be randomized into either EUS guided liver biopsy or USG guided percutaneous biopsy
Monitoring and assessment All patients would undergo vital and baseline parameter screening before randomization Based on randomization they will undergo the liver biopsy procedure Post procedure all the patients will be closely observed in the recovery area for at least 4 hours after the procedure VAS for pain will be noted 4-point patient satisfaction scale will be provided to them They will be followed up after 72 hours by a phone call or in their rooms if updated to check for any adverse effects
Pain will be assessed with a visual analogue scale VAS score minimum score 0 maximum score 10
Patient satisfaction will be evaluated by using a four-point scale Very satisfied Satisfied Less satisfied and Not satisfied at all
Statistical Analysis Descriptive data following a normal distribution will be reported as means standard deviation SD whereas nonparametric data will be reported as median range Comparisons between the two needles will be performed with a t test Wilcoxon rank sum test or chi-square test as appropriate
A Mantel-Haenszel test of trend will be performed to determine whether a linear association existed between EUS-LB sampling and VCTE and CAP results
Adverse effects
AEs will be defined as any deviation from the anticipated intra-procedure and post-procedural course
Hypothesis - i EUS-LB with a 19G FNB needle is non-inferior to PC-LB with a 18G full core biopsy needle with regards to total specimen length and diagnostic adequacy
ii There would be lesser procedure related pain and higher patient satisfaction with EUS-LB compared to PC-LB
Study population
1 Patients 18 years of age
2 Eligibility for deep sedation with propofol
3 Undergoing liver biopsy for diagnosisevaluationstaging
Study design All consecutive in-patients and out-patients requiring liver biopsy for evaluation of diffuse parenchymal liver disease will be evaluated for inclusion
Study period 1 year
Sample size with justification The percentage success rate of procurement of adequate liver biopsies defined by specimen length 15 mm and 8 CPTs was assumed to be 90 with PC-LB based on two recent retrospective studies comparing PC-LB with EUS-LB These studies used the bigger 16G Biopince needles Literature Bhogal N Endosc Int Open 2020 99 Facciorusso A Cancers 2021 100 With similar criteria for adequacy the success rates with EUS-LB were assumed to be 85 for non-inferiority comparison based on recent studies of EUS-LB using 19G Franseen needles Literature Hashimoto R Dig Dis Sci 2020 100 Aggarwal SN GIE 2021 972 Nallapeta N Hepatology 2021 556
With alpha-value of 10 power of 80 and non-inferiority margin of 10 we need to enroll 44 patients in each of PC-LB and EUS-LB arms for a total sample size of 88 patients We plan to enroll 90 patients in this trial to account for technical inadequacies
Intervention Patient after screening for all exclusion criteria will be randomized into either EUS guided liver biopsy or USG guided percutaneous biopsy
Monitoring and assessment All patients would undergo vital and baseline parameter screening before randomization Based on randomization they will undergo the liver biopsy procedure Post procedure all the patients will be closely observed in the recovery area for at least 4 hours after the procedure VAS for pain will be noted 4-point patient satisfaction scale will be provided to them They will be followed up after 72 hours by a phone call or in their rooms if updated to check for any adverse effects
Pain will be assessed with a visual analogue scale VAS score minimum score 0 maximum score 10
Patient satisfaction will be evaluated by using a four-point scale Very satisfied Satisfied Less satisfied and Not satisfied at all
Statistical Analysis Descriptive data following a normal distribution will be reported as means standard deviation SD whereas nonparametric data will be reported as median range Comparisons between the two needles will be performed with a t test Wilcoxon rank sum test or chi-square test as appropriate
A Mantel-Haenszel test of trend will be performed to determine whether a linear association existed between EUS-LB sampling and VCTE and CAP results
Adverse effects
AEs will be defined as any deviation from the anticipated intra-procedure and post-procedural course
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