Ignite Creation Date:
2024-05-06 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05307419
Status:
UNKNOWN
Last Update Posted:
2022-05-17
First Post:
2022-02-02
Brief Title:
Full Thickness vs Rectal Suction Biopsy in the Diagnosis of Hirschsprungs Disease
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
Prospective Randomised Blinded Study Comparing Full Thickness Biopsy and Rectal Suction Biopsies in the Diagnosis of Mb Hirschsprung
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
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:
BIOPSY
Brief Summary:
The objective of this prospective study is to compare the diagnostic accuracy of rectal suction biopsy RSB compared to full thickness rectal biopsy FTB in the diagnosis of Hirschsprungs Disease HD in children The secondary objective to compare cost-effectiveness of the two procedures
Detailed Description:
Diagnostic procedures involving the need of surgically obtaining tissue material carry the risk of complications and the risk of being inconclusive due to various reasons Lowering the risk of inconclusive diagnostic tests with highest sensitivity and specificity is of high importance in all diagnostic procedures
A full thickness rectal biopsy FTB includes both the submucosal and the myenteric nerve plexus for histological evaluation for presence of ganglion cells and hypertrophic nerve fibers FTB is performed in general anesthesia GA the biopsy is cut with scissors under direct visualization of the intestine and with suturing of the biopsy defect The other method is a suction biopsy RSB in which the biopsy is more superficial acquiring only the submucosal layers RSBs are performed with a specially designed rectoscope and the biopsy is obtained under negative pressure within the scope without visual guidance This procedure can be performed without anesthesia in children blow 1 year and does not necessitate suturing of the bowel
The problem with especially RSB could be that the biopsy is too superficial or too small in size for proper pathological evaluation As a consequence the child has to undergo a new procedure There is also the risk of false positive or false negative results which is a serious clinical issue carrying the risk of performing extensive surgery in an otherwise healthy child
Inconclusive biopsies differ extensively from series to series But the two largest studies show a rate of inconclusive biopsies at 10 for RSB and 5 for FTBFreidmacher and Bjorn The biopsy profile is similar with less than 1 severe complications Above Clavien DindoIII in both procedures with bleeding as dominating in RSB and Fever in FTB
Thus there are different advantages and disadvantages between the two methods of biopsy in children suspicious of HD and different centers advocate either A prospective comparison of both methods with the child as its own control is a more precise way to compare the two methods and has never been performed Thus this study is expected to give an answer to an important research question that will have potential implication worldwide
Hypothesis
Our hypothesis is that FTB has lower rate of inconclusive biopsies compared to RSB in the diagnosis of HD
Design
Prospective biopsy sample randomised study
Method
Patients referred for rectal biopsy at Odense University Hospital on the suspicion of HD will undergo both an FTB and RSB performed under GA in the same procedure
Patients will be randomised to which biopsy will be examined first at the pathology department If a diagnosis can bed securely made on the first tissue samples the other biopsy materials will be stores for examination by another pathologist 30 days later If any nerve cell is present the sample is negative for Mb Hirschsprung If no nervecells is present the biopsy the patient is positive for mb Hirschsprung If the tissue is evaluated as not suitable for diagnosis the sample is inconclusive If the sample is inconclusive the tissue from the other biopsy method is evaluated immediately to secure a fast diagnosis
All children between 0-15 years of age undergoing biopsies for diagnosis of the diagnosis of HD in Western Denmark from 19 2020 will be offered to participate and parental accept will be acquired
Cost-effectiveness will be measured upon with data from pathology cost and surgery utensils cost
These will be compared between the two groups
Power calculation
With the assumption of a 5 inconclusive rate for FTB and 10 for RSB 25 a McNemars test for matched comparison of dichotomous outcome inconclusive conclusive indicates the need for 282 patients to obtain 70 strength and a significance level of 5 P-value 005
These calculations are based on the largest numbers of biopsy evaluations in the literature
In these publications a rate of 5 inconclusive biopsies at FTB and 10 at RSB are found
Interim analyse will be performed after 25 50 and 75 Above 8 complications on 30-day follow-up will result in the study will be paused and examinations of the complications will be performed
A full thickness rectal biopsy FTB includes both the submucosal and the myenteric nerve plexus for histological evaluation for presence of ganglion cells and hypertrophic nerve fibers FTB is performed in general anesthesia GA the biopsy is cut with scissors under direct visualization of the intestine and with suturing of the biopsy defect The other method is a suction biopsy RSB in which the biopsy is more superficial acquiring only the submucosal layers RSBs are performed with a specially designed rectoscope and the biopsy is obtained under negative pressure within the scope without visual guidance This procedure can be performed without anesthesia in children blow 1 year and does not necessitate suturing of the bowel
The problem with especially RSB could be that the biopsy is too superficial or too small in size for proper pathological evaluation As a consequence the child has to undergo a new procedure There is also the risk of false positive or false negative results which is a serious clinical issue carrying the risk of performing extensive surgery in an otherwise healthy child
Inconclusive biopsies differ extensively from series to series But the two largest studies show a rate of inconclusive biopsies at 10 for RSB and 5 for FTBFreidmacher and Bjorn The biopsy profile is similar with less than 1 severe complications Above Clavien DindoIII in both procedures with bleeding as dominating in RSB and Fever in FTB
Thus there are different advantages and disadvantages between the two methods of biopsy in children suspicious of HD and different centers advocate either A prospective comparison of both methods with the child as its own control is a more precise way to compare the two methods and has never been performed Thus this study is expected to give an answer to an important research question that will have potential implication worldwide
Hypothesis
Our hypothesis is that FTB has lower rate of inconclusive biopsies compared to RSB in the diagnosis of HD
Design
Prospective biopsy sample randomised study
Method
Patients referred for rectal biopsy at Odense University Hospital on the suspicion of HD will undergo both an FTB and RSB performed under GA in the same procedure
Patients will be randomised to which biopsy will be examined first at the pathology department If a diagnosis can bed securely made on the first tissue samples the other biopsy materials will be stores for examination by another pathologist 30 days later If any nerve cell is present the sample is negative for Mb Hirschsprung If no nervecells is present the biopsy the patient is positive for mb Hirschsprung If the tissue is evaluated as not suitable for diagnosis the sample is inconclusive If the sample is inconclusive the tissue from the other biopsy method is evaluated immediately to secure a fast diagnosis
All children between 0-15 years of age undergoing biopsies for diagnosis of the diagnosis of HD in Western Denmark from 19 2020 will be offered to participate and parental accept will be acquired
Cost-effectiveness will be measured upon with data from pathology cost and surgery utensils cost
These will be compared between the two groups
Power calculation
With the assumption of a 5 inconclusive rate for FTB and 10 for RSB 25 a McNemars test for matched comparison of dichotomous outcome inconclusive conclusive indicates the need for 282 patients to obtain 70 strength and a significance level of 5 P-value 005
These calculations are based on the largest numbers of biopsy evaluations in the literature
In these publications a rate of 5 inconclusive biopsies at FTB and 10 at RSB are found
Interim analyse will be performed after 25 50 and 75 Above 8 complications on 30-day follow-up will result in the study will be paused and examinations of the complications will be performed
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?:
False
Is an FDA AA801 Violation?:
None