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Article
Peer-Review Record

Association between Vascular Calcification and Esophagojejunal Anastomotic Complications after Total Gastrectomy for Gastric Cancer: A Propensity-Matched Study

Curr. Oncol. 2022, 29(5), 3224-3231; https://doi.org/10.3390/curroncol29050262
by Su-Lim Lee 1, Chul-Hyo Jeon 2, Ki-Bum Park 2, Ho-Seok Seo 2 and Han-Hong Lee 2,*
Reviewer 1: Anonymous
Reviewer 2: Anonymous
Curr. Oncol. 2022, 29(5), 3224-3231; https://doi.org/10.3390/curroncol29050262
Submission received: 27 February 2022 / Revised: 30 April 2022 / Accepted: 2 May 2022 / Published: 3 May 2022

Round 1

Reviewer 1 Report

 

Association between Vascular Calcification and Esophagojejunal Anastomotic Complications after Total Gastrectomy for Gastric Cancer? A Propensity-Matched Study

 

Abstract

Esophagojejunal anastomosis (EJA) complications after total gastrectomy are related to significant morbidity and mortality. The aim of this study was to evaluate the association between arterial calcifications and EJA complications such as leak and stricture for gastric cancer. Between January 2014 and October 2019, 30 patients with EJA complications after total gastrectomy were enrolled and matched to 30 patients without complications. Arterial calcification grade on preoperative computed tomography (CT) was reported in the abdominal aorta and superior mesenteric artery (SMA) as “absent”, “minor”, or “major”, and in the jejunal vascular arcade (JVA) and left inferior phrenic artery (LIPA) as “absent” or “present”. Chi-square test was used to compare the variables between the two groups. p-Value < 0.050 was considered statistically significant. Among 30 patients, the numbers of patients with leak and stricture were 23 and 7, respectively. Aortic calcifications were not associated with EJA complications regardless of their grade (p = 0.440). Only major SMA calcifications were associated with EJA complications, as they were present in 5 patients (16.7%) in the complication group and absent in the non-complication group (p = 0.020). Major SMA calcifications were more related to anastomotic stricture than leak. Three (13.0%) out of 23 patients with leak and 2 (28.6%) out of 7 with stricture had major SMA calcifications (p = 0.028). No calcifications were detected in the JVA or LIPA in any of the 60 patients. Major SMA calcifications were found to be associated with EJA complications, especially in stricture.

 

Comment: pls state the study design: is it a prospective trial or retrospective data review ? If it is a prospective study, the CONSORT checklist should be used as a guide too.

 

 

  1. Introduction

In this study, we attempted to find if an association exists between vascular 53 calcifications and the incidence of EJA complications after total gastrectomy for gastric 54 cancer using preoperative computed tomography (CT) assessment of the location and 55 extent of calcifications.

 

Comment:

 

 

  1. Materials and Methods

2.1. Definitions of complications

2.2. Patients & Matching

2.3. Anastomosis Technique

2.4. Image Acquisition and Evaluation

 

Comment : If this is prospective clinical trial, please also consider to report the following sections:

 

Title and abstract

1a

Identification as a randomised trial in the title

1b

Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts21 31)

Introduction

Background and objectives

2a

Scientific background and explanation of rationale

2b

Specific objectives or hypotheses

Methods

Trial design

3a

Description of trial design (such as parallel, factorial) including allocation ratio

3b

Important changes to methods after trial commencement (such as eligibility criteria), with reasons

Participants

4a

Eligibility criteria for participants

4b

Settings and locations where the data were collected

Interventions

5

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

Outcomes

6a

Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

6b

Any changes to trial outcomes after the trial commenced, with reasons

Sample size

7a

How sample size was determined

7b

When applicable, explanation of any interim analyses and stopping guidelines

Randomisation:

Sequence generation

8a

Method used to generate the random allocation sequence

8b

Type of randomisation; details of any restriction (such as blocking and block size)

Allocation concealment mechanism

9

Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

Implementation

10

Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

Blinding

11a

If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how

11b

If relevant, description of the similarity of interventions

Statistical methods

12a

Statistical methods used to compare groups for primary and secondary outcomes

12b

Methods for additional analyses, such as subgroup analyses and adjusted analyses

Results

Participant flow (a diagram is strongly recommended)

13a

For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome

13b

For each group, losses and exclusions after randomisation, together with reasons

Recruitment

14a

Dates defining the periods of recruitment and follow-up

14b

Why the trial ended or was stopped

Baseline data

15

A table showing baseline demographic and clinical characteristics for each group

Numbers analysed

16

For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

Outcomes and estimation

17a

For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

17b

For binary outcomes, presentation of both absolute and relative effect sizes is recommended

Ancillary analyses

18

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

Harms

19

All important harms or unintended effects in each group (for specific guidance see CONSORT for harms28)

Discussion

Limitations

20

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

Generalisability

21

Generalisability (external validity, applicability) of the trial findings

Interpretation

22

Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence

Other information

Registration

23

Registration number and name of trial registry

Protocol

24

Where the full trial protocol can be accessed, if available

Funding

25

Sources of funding and other support (such as supply of drugs), role of funders

 

2.5. Statistical analysis

The author has correctly selected chi square test for association (also called the chi-square test for independence) which is used to find a relationship between two categorical variables.  

 

 

Other comments

 

Table 1. Modified visual arterial calcification grading system

Table 2. Comparison of baseline characteristics between complication and non-complication groups after propensity score matching

Table 3. Association between arterial calcifications with esophagojejunal anastomosis complications

Table 4. The correlation between the kinds of anastomotic complication and the degree of SMA calcification

Table 1-4 are easy to read and well presented

 

The limitation of this study lies in the small sample size due to the relatively low 255 incidence of EJA complications. However, it was possible to conclude that major SMA 256 calcifications might induce tissue ischemia that compromises esophagojejunal 257 anastomotic healing after total gastrectomy for gastric cancer, and lead to anastomotic 258 complications, particularly stricture, rather than leak

 

Comment: to include Sample Size calculation

 

Conclusions

In conclusion, vascular calcification could affect for esophagojejunostomy condition 261 after total gastrectomy. Preoperative CT scan could predict patients at risk. Further 262 studies are needed to evaluate advanced techniques such as intraoperative ICG 263 angiography in preventing EJA complications in patients with major SMA calcifications

Comment: the conclusion should be expanded to include further summary

Author Response

Abstract

Comment: pls state the study design: is it a prospective trial or retrospective data review ? If it is a prospective study, the CONSORT checklist should be used as a guide too.

 

Thank you for comment. Our study is retrospective review. We added the study design in abstract.

--> Between January 2014 and October 2019, 30 patients with EJA complications after total gastrectomy were enrolled and matched to 30 patients without complications through retrospective data review.

 

  1. Materials and Methods

Comment : If this is prospective clinical trial, please also consider to report the following sections:

 

Our study is retrospective study. Thank you for your consideration.

 

2.5. Statistical analysis

Comment : The author has correctly selected chi square test for association (also called the chi-square test for independence) which is used to find a relationship between two categorical variables.

 

Thank you for your comment.

 

Other comments

Table 1-4 are easy to read and well presented

 

Thank you for your comment.

 

Comment: to include Sample Size calculation

 

Our study is retrospective study using data review. Therefore, sample size calculation was not conducted. Thank you for your comment.

 

Comment: the conclusion should be expanded to include further summary

 

We added further summary in conclusion.

--> In conclusion, vascular calcification could affect for esophagojejunostomy condition after total gastrectomy. Especially, major SMA calcification is associated with stricture of EJA. Preoperative CT scan could predict patients at risk. Further studies are needed to evaluate advanced techniques such as intraoperative ICG angiography in preventing EJA complications in patients with major SMA calcifications.

Reviewer 2 Report

Leak and strictures of the anastomosis are the most severe complications after total gastectomy in patients with gastric cancer. Recently, indications for detailed operations have been significantly expanded, including elderly patients who have severe comorbid pathology and vascular disorders. From these positions, of great interest is the analysis of the effect of vascular patency disorders on the frequency of postoperative complications in the area of ​​the esophago-intestinal anastomosis. The article is of interest to practical surgeons. I believe this study is relevant.  

The results of this study can be used as additional factors for determining the risk of postoperative complications and for selecting patients with gastric cancer for surgical treatment.

The study is not randomized and is retrospective. The authors carried out a qualitative and comprehensive analysis of the literature on this issue.  To my mind, the article is very interesting. I see no need for additional changes. 

The conclusion logically ends the article. The authors showed that major SMA calcifications were associated with EJA complications in 16.7% of cases. References in the text of the article fully correspond to the article list of references, both in the order of citation and in content. The authors used contemporary literature. 

 

Author Response

Thank you for insightful comments. 

This manuscript is a resubmission of an earlier submission. The following is a list of the peer review reports and author responses from that submission.


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