Title: Surface Area Outcomes in EUS-Guided Liver Biopsy: A Comparative Study of Franseen
and Fork-tip Needles
Version: 2 Date: 07 Feb 2025
Reviewer's report:
The authors present the results of a retrospective study enrolling a small number of patients (20)
in each arm, comparing the performances of two different EUS-FNB needles in EUS-guided
liver biopsy for parenchymal liver disease. The paper is fairly well written. As criticism, the
study has the drawbacks of a small retrospective study.
Besides,
1. There seems to be some problems with the statistical analysis. For example, there are some
striking differences between the two groups – for example age, or proportion of male/female,
though not statistically significant, which is odd. It is also not specified which statistical analysis
software was used. I would suggest repeat the statistical analysis with an alternate software.
2. The same with the proportion of acute hepatitis changes in the histological samples.
3. The same with the comparison of the number of portal tracts. The results in the table and the
graphics show a difference that seems more likely statistically significant. An alternate software
should be used in this case also.
4. The majority of the patients has suspicion of autoimmune liver disease. This has to be clearly
mentioned in the abstract and conclusions of the paper.
5. Since no dedicated evaluation per pass was made (i.e. material from each pass to be processed
and evaluated separately), deduction of variables per pass are just a surrogate. The authors need
to specify this clearly in the results section, discussions and conclusions of the paper.
6. The adverse events such as postprocedural pain more likely were not recorded. Please state
this clearly in the paper.
7. It should be clearly presented (in the results section) and afterwards discussed how did fibrosis
staging and involvement by steatosis influence the results of biopsy. Increased the chance/
decreased the change of yielding a good fragment? Which degree of fibrosis or MAFLD, and
by how many times?
8. The same magnification should be used when comparatively presenting the pictures of liver
fragments obtained with the two different needles.
9. The authors state that “two pathologists independently validated the histological evaluation
and quantification of portal tracts”; what was their interobserver agreement? What happened if
they disagreed?
10. Do not use the terms “sequentially assigned” or “sequential assignment”; it induces the false
idea of a prospective study.
11. I do not understand the idea of “the largest tissue sample obtained per pass was”. Why do
you have to use the term “largest”?
12. The authors state in two consecutive sentences that:
- fibrosis staging was identified as a significant determinant of the total hepatic tissue area
- factors such as fibrosis staging were not found to significantly influence the total hepatic tissue
area.
Please redo the analysis. Is or is not fibrosis staging associated with the tissue area?
13. What do you mean by “suspected cases in pathological diagnoses” (discussion section).
Please explain.
14. In this study, “both a trainer and a trainee performed each procedure” (however, not
mentioned in the methods section). It is not specified who did what procedure. This definitely
could have affected the study results.
Title: Surface Area Outcomes in EUS-Guided Liver Biopsy: A Comparative Study of Franseen
and Fork-tip Needles
Version: 2 Date: 07 Feb 2025
Reviewer's report:
The authors present the results of a retrospective study enrolling a small number of patients (20)
in each arm, comparing the performances of two different EUS-FNB needles in EUS-guided
liver biopsy for parenchymal liver disease. The paper is fairly well written. As criticism, the
study has the drawbacks of a small retrospective study.
Besides,
1. There seems to be some problems with the statistical analysis. For example, there are some
striking differences between the two groups – for example age, or proportion of male/female,
though not statistically significant, which is odd. It is also not specified which statistical analysis
software was used. I would suggest repeat the statistical analysis with an alternate software.
2. The same with the proportion of acute hepatitis changes in the histological samples.
3. The same with the comparison of the number of portal tracts. The results in the table and the
graphics show a difference that seems more likely statistically significant. An alternate software
should be used in this case also.
4. The majority of the patients has suspicion of autoimmune liver disease. This has to be clearly
mentioned in the abstract and conclusions of the paper.
5. Since no dedicated evaluation per pass was made (i.e. material from each pass to be processed
and evaluated separately), deduction of variables per pass are just a surrogate. The authors need
to specify this clearly in the results section, discussions and conclusions of the paper.
6. The adverse events such as postprocedural pain more likely were not recorded. Please state
this clearly in the paper.
7. It should be clearly presented (in the results section) and afterwards discussed how did fibrosis
staging and involvement by steatosis influence the results of biopsy. Increased the chance/
decreased the change of yielding a good fragment? Which degree of fibrosis or MAFLD, and
by how many times?
8. The same magnification should be used when comparatively presenting the pictures of liver
fragments obtained with the two different needles.
9. The authors state that “two pathologists independently validated the histological evaluation
and quantification of portal tracts”; what was their interobserver agreement? What happened if
they disagreed?
10. Do not use the terms “sequentially assigned” or “sequential assignment”; it induces the false
idea of a prospective study.
11. I do not understand the idea of “the largest tissue sample obtained per pass was”. Why do
you have to use the term “largest”?
12. The authors state in two consecutive sentences that:
- fibrosis staging was identified as a significant determinant of the total hepatic tissue area
- factors such as fibrosis staging were not found to significantly influence the total hepatic tissue
area.
Please redo the analysis. Is or is not fibrosis staging associated with the tissue area?
13. What do you mean by “suspected cases in pathological diagnoses” (discussion section).
Please explain.
14. In this study, “both a trainer and a trainee performed each procedure” (however, not
mentioned in the methods section). It is not specified who did what procedure. This definitely
could have affected the study results.
Please review this paper.
user
Title: Surface Area Outcomes in EUS-Guided Liver Biopsy: A Comparative Study of Franseen
and Fork-tip Needles
Version: 2 Date: 07 Feb 2025
Reviewer's report:
The authors present the results of a retrospective study enrolling a small number of patients (20)
in each arm, comparing the performances of two different EUS-FNB needles in EUS-guided
liver biopsy for parenchymal liver disease. The paper is fairly well written. As criticism, the
study has the drawbacks of a small retrospective study.
Besides,
1. There seems to be some problems with the statistical analysis. For example, there are some
striking differences between the two groups – for example age, or proportion of male/female,
though not statistically significant, which is odd. It is also not specified which statistical analysis
software was used. I would suggest repeat the statistical analysis with an alternate software.
2. The same with the proportion of acute hepatitis changes in the histological samples.
3. The same with the comparison of the number of portal tracts. The results in the table and the
graphics show a difference that seems more likely statistically significant. An alternate software
should be used in this case also.
4. The majority of the patients has suspicion of autoimmune liver disease. This has to be clearly
mentioned in the abstract and conclusions of the paper.
5. Since no dedicated evaluation per pass was made (i.e. material from each pass to be processed
and evaluated separately), deduction of variables per pass are just a surrogate. The authors need
to specify this clearly in the results section, discussions and conclusions of the paper.
6. The adverse events such as postprocedural pain more likely were not recorded. Please state
this clearly in the paper.
7. It should be clearly presented (in the results section) and afterwards discussed how did fibrosis
staging and involvement by steatosis influence the results of biopsy. Increased the chance/
decreased the change of yielding a good fragment? Which degree of fibrosis or MAFLD, and
by how many times?
8. The same magnification should be used when comparatively presenting the pictures of liver
fragments obtained with the two different needles.
9. The authors state that “two pathologists independently validated the histological evaluation
and quantification of portal tracts”; what was their interobserver agreement? What happened if
they disagreed?
10. Do not use the terms “sequentially assigned” or “sequential assignment”; it induces the false
idea of a prospective study.
11. I do not understand the idea of “the largest tissue sample obtained per pass was”. Why do
you have to use the term “largest”?
12. The authors state in two consecutive sentences that:
- fibrosis staging was identified as a significant determinant of the total hepatic tissue area
- factors such as fibrosis staging were not found to significantly influence the total hepatic tissue
area.
Please redo the analysis. Is or is not fibrosis staging associated with the tissue area?
13. What do you mean by “suspected cases in pathological diagnoses” (discussion section).
Please explain.
14. In this study, “both a trainer and a trainee performed each procedure” (however, not
mentioned in the methods section). It is not specified who did what procedure. This definitely
could have affected the study results.
assistant