Review for 10.1186/s12876-022-02116-0 (2022)

Reviewer’s report
Title: 
“One-step” approach versus “Step-up” approach minimally invasive
treatment for infected pancreatic necrosis: a study protocol for a single-center,
prospective, randomized controlled trial
Version: 
0 
Date: 
06 Dec 2021
Reviewer's report:
PEER REVIEWER ASSESSMENTS: 
OBJECTIVE - Full research articles: is there a clear objective that addresses a
testable research question(s) (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 minor issues
EXECUTION - Are the experiments and analyses performed with technical rigor
to allow confidence in the results?
N/A - no experiments or analyses
STATISTICS - Is the use of statistics in the manuscript appropriate?
N/A - there are no statistics in this study
INTERPRETATION - Is the current interpretation/discussion of the results
reasonable and not overstated?
No - there are minor issues
OVERALL MANUSCRIPT POTENTIAL - Is the current version of this work
technically sound? If not, can revisions be made to make the work technically
sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS: 
GENERAL COMMENTS: 
This is a reasonably well-prepared protocol of a RCT. It is based on a
preliminary observational study by the group and, overall, is positioned well to
become a valuable contribution to the literature.
REQUESTED REVISIONS: 
The following comments may help improve the manuscript:
1. One options for debridement that has been ignored by the authors is
endoscopic transmural (transgastric or transduodenal) necrosectomy. Please
discuss.
2. Mortality as a secondary endpoint was defined as "The incidence of in-
hospital death and deaths within 30 days of discharge". Given that patients will
be followed up for 2 years, do the authors maintain that a patient who dies in,
say, 90 days after hospitalization will not be counted?
3. The correct term to use throughout the manuscript is "infected pancreatic
necrosis", not "infectious pancreatic necrosis".
4. Not clear whether patients with isolated infected peri-pancreatic necrosis are
to be included or excluded.
5. Please define the following secondary endpoints/exclusions: chronic
pancreatitis, exocrine pancreatic dysfinction, endocrine pancreatic dysfinction.
The authors may want to use PMID 30482911 as a guideline.
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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
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No
Is the use of statistics and treatment of uncertainties appropriate?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes