Review for 10.1186/s12876-023-02696-5 (2023)

Reviewer’s report
Title: 
A novel capsule endoscopy for upper and mid-GI tract: the UMGI capsule
Version: 
1 
Date: 
05 Feb 2023
Reviewer's report:
The pilot study described in the article "A novel capsule endoscopy for upper
and mid GI tract: the UMGI capsule" focuses on a topic of great interest such as
the use of capsule endoscopy to study both upper and middle gastrointestinal
tract, in order to achieve a non- or minimally-invasive tool with high technical
and clinical performance associated with a good tolerability.
Unfortunately, this study presents major concerns:
1. It is not clear if this new device can add advantages. In the bleeding setting
EGD is required, as stated in the international guidelines cited by the authors,
especially in those cases with high suspect of UGI bleeding. The operativity (not
only hemostasis but also washing and suctioning) and less time-wasting of EGD
are very important. Even in other cases, such as patients with GI complaints, the
possibility to wash and biopsy the mucosa is often needed. Maybe the capsule
can play a role in a "second look" setting?
2. The authors present a device to study UMGI tract, but only 2/3 of 30 patients
have a mid-gut examination, furthermore without a comparator. It is all focused
on UGI part.
3. One of the main aims of the study is to compare capsule and EGD DY,
without taking into consideration the clinical relevance of lesions detected. The
only advantage of the capsule in the UGI seems to be in the bulb, but are all
these findings clinical significant (Saurin classification for capsule findings)?. 
4. It is often stated in different rephrased sentences that patients taking
antithrombotic or non-steroidal anti-inflammatory drugs are recommended to be
screened to GI injuries. This is not correct: there are some studies that conclude
that they are at mayor risk of developing GI injuries and/or GI bleeding, but there
is not a need to screen (with which time interval?) them with UGI or UMGI
endoscopy without clinical suspect of lesions/GI bleeding. 
5. One point of strength, according to the authors, is the higher acceptability of
the capsule compared to standard gastroscopy. But they compare capsule to EGD
performed without sedation, which is not the standard, leading to a strong bias. 
Moreover, in the added part at Page 13 line 37 the sentence "gastrointestinal
injuries induced by invasive procedure" should be removed. It cannot justify the
choice not to perform sedation because it is an EGD complication, regardless of
sedation. 
6. Another critical point is the UGI examination time, which is very long
compared to a standard EGD (in addition EGD examination time is lacking in
this work). Time is a very important point nowadays, especially in settings like
GI bleedings.
7. Discussion: "This study confirmed the diagnostic ability of UMGI capsule for
esophageal diseases with a consistency of 100% with EGD". It should be took
into account that there is still a limitation of circumferential view (only 2/3 of the
patients had complete view of EGJ), so this affirmation is a little strong. 
Other minor concerns are:
1. There are two errors in the abstract:
- (line 20): "The main outcomes was technical.." it is singular so "outcome";
- (line 31): "detection rates of 100%, 80.0% and 86.7% .." it should be used the
same number of decimals so "100.0%"
2. Method section - Study patients. Page 5 line 53: 
"...criteria were excluded
including" , "including" should be omitted.
3. Method section - Study outcomes. Page 8 line 1: "Secondary outcomes
including the visualization of UMGI tract..." , 
"including" should be omitted.
Furthermore "visualization of the UMGI tract" should be defined better.
4. Results section - Diagnostic performance. Page 10 line 50 and 53:
lymphangectasias are reported twice. Please check.
5. Figure legends, Figure 1 - source: please check grammatical and construction
errors of the period
6. Table 3: please check the small bowel part of the table, "both examination"
column: it should be reported N.A. (or similar, as reported in the "EGD only"
column) and not 0.
Declaration of competing interests
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salary from an organisation that may in any way gain or lose financially
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or in the future?
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Do you hold or are you currently applying for any patents relating to the
content of the manuscript?
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organization that holds or has applied for patents relating to the content of
the manuscript?
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paper?
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interests' below. If your reply is yes to any, please give details below.
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Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
No
Are the methods sufficiently described to allow the study to be repeated?
Yes
Is the use of statistics and treatment of uncertainties appropriate?
Yes
Is the presentation of the work clear?
No
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
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No