Review for 10.1186/s12876-022-02610-5 (2022)

Reviewer’s report
Title: 
Long-term outcomes of endoscopic transpapillary gallbladder drainage
using a novel spiral plastic stent in acute calculus cholecystitis
Version: 
1 
Date: 
19 Aug 2022
Reviewer's report:
"PEER REVIEWER ASSESSMENTS: 
OBJECTIVE - Full research articles: is there a clear objective that addresses one
or several testable research questions? (Brief or other article types: is there a
clear objective?)
No - there are minor issues
DESIGN - Is the current approach (including controls and analysis protocols)
appropriate for the objective?
No - there are major issues
EXECUTION - Are the experiments and analyses performed with sufficient
technical rigor to allow confidence in the results?
No - there are major issues
STATISTICS - Is the use of statistics in the manuscript appropriate?
Yes - appropriate statistical analyses have been used in the study
INTERPRETATION - Is the current interpretation/discussion of the results
reasonable and not overstated?
No - there are major issues
OVERALL MANUSCRIPT POTENTIAL - Has the author addressed your
concerns sufficiently for you to now recommend the work as a technically sound
contribution? If not, can further revisions be made to make the work technically
sound?
Maybe - with major revisions
PEER REVIEWER COMMENTS: 
GENERAL COMMENTS: Dear authors
I read with interest your research paper about this novel device and technique for
gallbladder drainage.
I would like to make some comments:
1. The treatment of acute calculous cholecystitis is a very debated topic.
Guidelines recommend ELC as the treatment of choice. However several patients
do not receive early cholecystectomy for several reasons as you stated. In your
paper you described the results of this alternative technique: which were the
indications for EGBS instead conservative management with only antibiotics? I
think this is the main problem of your research. Since it is a retrospective study
is burdened for definition by a selection bias. I think it's mandatory to accurately
describe the indication for EGBS. It would be very interesting to see compared
long term results between NOM with antibiotics and NOM with EGBS. It is
justified to perform EGBS? Data provided do not provide sufficient evidence to
support this technique and I think you should revise your conclusions.
2. In the introduction you cited a recent meta-analysis comparing ELC with
PTGBD, stating that PTGBD has less complications that ELC. I think this is
completely wrong and misleading! The meta-analysis described higher mortality
in PTGBD (HR 3.68) but less complications. Please correct.
3. You declared that the study period was 2011-2019. Then you declared that
follow-up was every six month. How is possible that median follow up was only
234 days (8 months). Since the focus of your study is the long term follow up I
think it is mandatory to have an adequate follow up of all these patients (At least
median of 24 months).
4. About late cholecystectomy: please provide technical information about the
removal of the biliary stent. With a stent in the cystic duct it's very difficult to
perform a standard cholecystectomy. Provide timing and technique of removal.
5. Please remove data about stent migration in duodenum and put them in the
result section
REQUESTED REVISIONS: 
please see my comments above"
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Is the study design appropriate to answer the research question (including the use
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