Title: Endobiliary radiofrequency ablation in recurrence and unresectable perihilar
cholangiocarcinoma
Version: 0 Date: 25 Mar 2025
Reviewer's report:
Thank you for the opportunity to review this manuscript. I commend the authors for addressing
an important clinical issue. However, several points need clarification and improvement. Please
find my comments below.
Major Comments
1. The study includes a relatively small sample size, which may lead to insufficient statistical
power. It is generally advisable to perform a sample size calculation prior to conducting an RCT,
particularly when stent patency and overall survival are the primary outcomes. Please provide a
detailed explanation in the manuscript regarding how the sample size was determined, or justify
why a formal calculation was not performed.
2. The manuscript specifies stent patency and overall survival (OS) as primary outcomes, yet
their definitions are not clearly stated. In particular, the criteria for defining stent occlusion
should be explicitly described, as this is essential for reproducibility. Additionally, please present
Kaplan-Meier curves for both stent patency and OS.
3. Five patients received percutaneous stent placement, but the specific criteria or rationale
for choosing this approach over endoscopic stenting are not clearly described. Furthermore, it
is unclear whether radiofrequency ablation (RFA) for these five cases was performed via the
percutaneous route or endoscopically. There is limited information in the Methods section, so
please provide additional details in both the Methods and Results sections, clarifying how and
why the percutaneous approach was chosen and how ablation was performed in these cases.
4. In the Results section, the manuscript states: “CCA patients who received EBRFA had a trend
in survival time to be better than patients who received SEMS (OS = 94 vs. 79 days, HR = 1.31,
p = 0.735).” However, with a p-value of 0.735, one cannot conclude that there is a meaningful
trend favoring EBRFA.
5.
Minor Comment
1. Abbreviations used in the tables are not fully explained. Please provide a clear list of all
abbreviations below each table so readers can interpret them easily.
Title: Endobiliary radiofrequency ablation in recurrence and unresectable perihilar
cholangiocarcinoma
Version: 0 Date: 25 Mar 2025
Reviewer's report:
Thank you for the opportunity to review this manuscript. I commend the authors for addressing
an important clinical issue. However, several points need clarification and improvement. Please
find my comments below.
Major Comments
1. The study includes a relatively small sample size, which may lead to insufficient statistical
power. It is generally advisable to perform a sample size calculation prior to conducting an RCT,
particularly when stent patency and overall survival are the primary outcomes. Please provide a
detailed explanation in the manuscript regarding how the sample size was determined, or justify
why a formal calculation was not performed.
2. The manuscript specifies stent patency and overall survival (OS) as primary outcomes, yet
their definitions are not clearly stated. In particular, the criteria for defining stent occlusion
should be explicitly described, as this is essential for reproducibility. Additionally, please present
Kaplan-Meier curves for both stent patency and OS.
3. Five patients received percutaneous stent placement, but the specific criteria or rationale
for choosing this approach over endoscopic stenting are not clearly described. Furthermore, it
is unclear whether radiofrequency ablation (RFA) for these five cases was performed via the
percutaneous route or endoscopically. There is limited information in the Methods section, so
please provide additional details in both the Methods and Results sections, clarifying how and
why the percutaneous approach was chosen and how ablation was performed in these cases.
4. In the Results section, the manuscript states: “CCA patients who received EBRFA had a trend
in survival time to be better than patients who received SEMS (OS = 94 vs. 79 days, HR = 1.31,
p = 0.735).” However, with a p-value of 0.735, one cannot conclude that there is a meaningful
trend favoring EBRFA.
5.
Minor Comment
1. Abbreviations used in the tables are not fully explained. Please provide a clear list of all
abbreviations below each table so readers can interpret them easily.
Please review this paper.
user
Title: Endobiliary radiofrequency ablation in recurrence and unresectable perihilar
cholangiocarcinoma
Version: 0 Date: 25 Mar 2025
Reviewer's report:
Thank you for the opportunity to review this manuscript. I commend the authors for addressing
an important clinical issue. However, several points need clarification and improvement. Please
find my comments below.
Major Comments
1. The study includes a relatively small sample size, which may lead to insufficient statistical
power. It is generally advisable to perform a sample size calculation prior to conducting an RCT,
particularly when stent patency and overall survival are the primary outcomes. Please provide a
detailed explanation in the manuscript regarding how the sample size was determined, or justify
why a formal calculation was not performed.
2. The manuscript specifies stent patency and overall survival (OS) as primary outcomes, yet
their definitions are not clearly stated. In particular, the criteria for defining stent occlusion
should be explicitly described, as this is essential for reproducibility. Additionally, please present
Kaplan-Meier curves for both stent patency and OS.
3. Five patients received percutaneous stent placement, but the specific criteria or rationale
for choosing this approach over endoscopic stenting are not clearly described. Furthermore, it
is unclear whether radiofrequency ablation (RFA) for these five cases was performed via the
percutaneous route or endoscopically. There is limited information in the Methods section, so
please provide additional details in both the Methods and Results sections, clarifying how and
why the percutaneous approach was chosen and how ablation was performed in these cases.
4. In the Results section, the manuscript states: “CCA patients who received EBRFA had a trend
in survival time to be better than patients who received SEMS (OS = 94 vs. 79 days, HR = 1.31,
p = 0.735).” However, with a p-value of 0.735, one cannot conclude that there is a meaningful
trend favoring EBRFA.
5.
Minor Comment
1. Abbreviations used in the tables are not fully explained. Please provide a clear list of all
abbreviations below each table so readers can interpret them easily.
assistant