Title: Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study
protocol of a prospective multicenter clinical trial
Version: 2 Date: 20 May 2023
Reviewer's report:
Dear Authors
I have read their manuscript with great interest.
In line 47 you state “It has been proven that secondary surgery after initial local resection (or
an attempt) has no negative effects on the development of LNM or cancer recurrence(8,12-16)
…… quality of life (QoL) without increased fear of cancer recurrence compared to patients who
underwent a segmental resection(17)..
This is true as cited for endoscopic resections, CAL-WR is a different technique and therefore
your assumption that it is also true for CAL-WR is not shown in the publication you cite. Please
clarify. This is a topic which should be addressed as secondary endpoint.
The decision criteria of Expert panel and of the Multidisciplinary team meeting are not specified.
Therefor a possible selection bias can´t be properly identified. Please give standardized decision
criteria.
The sample size conclusion is not conclusive. Where does the “assuming a proportion of 45%
of all patients with pT1 CC to be cured with local resection” come from? Please clarify the
proportion of patients with pT1 colon carcinoma for whom CAL-WR could be a curative
treatment, based on histology and risk factors of published data and based on your published
technical success data.
Title: Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study
protocol of a prospective multicenter clinical trial
Version: 2 Date: 20 May 2023
Reviewer's report:
Dear Authors
I have read their manuscript with great interest.
In line 47 you state “It has been proven that secondary surgery after initial local resection (or
an attempt) has no negative effects on the development of LNM or cancer recurrence(8,12-16)
…… quality of life (QoL) without increased fear of cancer recurrence compared to patients who
underwent a segmental resection(17)..
This is true as cited for endoscopic resections, CAL-WR is a different technique and therefore
your assumption that it is also true for CAL-WR is not shown in the publication you cite. Please
clarify. This is a topic which should be addressed as secondary endpoint.
The decision criteria of Expert panel and of the Multidisciplinary team meeting are not specified.
Therefor a possible selection bias can´t be properly identified. Please give standardized decision
criteria.
The sample size conclusion is not conclusive. Where does the “assuming a proportion of 45%
of all patients with pT1 CC to be cured with local resection” come from? Please clarify the
proportion of patients with pT1 colon carcinoma for whom CAL-WR could be a curative
treatment, based on histology and risk factors of published data and based on your published
technical success data.
Please review this paper.
user
Title: Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study
protocol of a prospective multicenter clinical trial
Version: 2 Date: 20 May 2023
Reviewer's report:
Dear Authors
I have read their manuscript with great interest.
In line 47 you state “It has been proven that secondary surgery after initial local resection (or
an attempt) has no negative effects on the development of LNM or cancer recurrence(8,12-16)
…… quality of life (QoL) without increased fear of cancer recurrence compared to patients who
underwent a segmental resection(17)..
This is true as cited for endoscopic resections, CAL-WR is a different technique and therefore
your assumption that it is also true for CAL-WR is not shown in the publication you cite. Please
clarify. This is a topic which should be addressed as secondary endpoint.
The decision criteria of Expert panel and of the Multidisciplinary team meeting are not specified.
Therefor a possible selection bias can´t be properly identified. Please give standardized decision
criteria.
The sample size conclusion is not conclusive. Where does the “assuming a proportion of 45%
of all patients with pT1 CC to be cured with local resection” come from? Please clarify the
proportion of patients with pT1 colon carcinoma for whom CAL-WR could be a curative
treatment, based on histology and risk factors of published data and based on your published
technical success data.
assistant