Reviewer's report
Title:Rectal indomethacin versus placebo to reduce the incidence of pancreatitis
after endoscopic retrograde cholangiopancreatography. Results of a controlled
clinical trial.
Version:2Date:5 February 2015
Reviewer: Alberto Mariani
Reviewer's report:
The issue of the medical prevention of post-ERCP pancreatitis (PEP) has been
recently emphasized thanks to updated European (Dumonceau 2014) and
American (Tenner 2013) guidelines. In this study, authors have confirmed the
efficacy of rectal administration of indomethacin for the prevention of PEP in
high-risk patients.
The topic is of great interest, but some methodological problems put aside the
relevance of the results.
The article is presented as a randomized study, but some criticisms can raise
about its prospective design: both the National Clinical Trials identifier number
and the two references used to define the high risk patients were dated April
2014 and 2015, respectively, while the period of enrollment of the patients
started before (from July 2012 to December 2013).
It is also surprising that the informed consent was given from “patients under the
effect of sedative medication” (from line 183 to 188, page 8): the informed
consent was obtained at the end of ERCP (line 184) and after that the
administration of suppositories, thus, with “patients under the effect of sedative
medication” (line 188).
It is not the case to report in the Methods section (page 8 line 179-180) the
“pancreatic fistulas” as an indication for the placement of pancreatic stent
because of the very low rate of a such disease. It should rather be considered as
an exclusion criteria.
In the Methods section, the references to the consensus definition of PEP
(Cotton 2001) and that for the rate of PEP (25%) reported for high risk patients
are not reported (page 9 line 203 and page 10 line 226, respectively).
In the Discussion section the added value of the results of this study in
comparison with those already published is lacking. Furthermore, the discussion
has to be entirely re-written: it is too long and it seems more a review than a
critical analysis of the results of this and other studies.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests.
Reviewer's report
Title:Rectal indomethacin versus placebo to reduce the incidence of pancreatitis
after endoscopic retrograde cholangiopancreatography. Results of a controlled
clinical trial.
Version:2Date:5 February 2015
Reviewer: Alberto Mariani
Reviewer's report:
The issue of the medical prevention of post-ERCP pancreatitis (PEP) has been
recently emphasized thanks to updated European (Dumonceau 2014) and
American (Tenner 2013) guidelines. In this study, authors have confirmed the
efficacy of rectal administration of indomethacin for the prevention of PEP in
high-risk patients.
The topic is of great interest, but some methodological problems put aside the
relevance of the results.
The article is presented as a randomized study, but some criticisms can raise
about its prospective design: both the National Clinical Trials identifier number
and the two references used to define the high risk patients were dated April
2014 and 2015, respectively, while the period of enrollment of the patients
started before (from July 2012 to December 2013).
It is also surprising that the informed consent was given from “patients under the
effect of sedative medication” (from line 183 to 188, page 8): the informed
consent was obtained at the end of ERCP (line 184) and after that the
administration of suppositories, thus, with “patients under the effect of sedative
medication” (line 188).
It is not the case to report in the Methods section (page 8 line 179-180) the
“pancreatic fistulas” as an indication for the placement of pancreatic stent
because of the very low rate of a such disease. It should rather be considered as
an exclusion criteria.
In the Methods section, the references to the consensus definition of PEP
(Cotton 2001) and that for the rate of PEP (25%) reported for high risk patients
are not reported (page 9 line 203 and page 10 line 226, respectively).
In the Discussion section the added value of the results of this study in
comparison with those already published is lacking. Furthermore, the discussion
has to be entirely re-written: it is too long and it seems more a review than a
critical analysis of the results of this and other studies.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests.
Please review this paper.
user
Reviewer's report
Title:Rectal indomethacin versus placebo to reduce the incidence of pancreatitis
after endoscopic retrograde cholangiopancreatography. Results of a controlled
clinical trial.
Version:2Date:5 February 2015
Reviewer: Alberto Mariani
Reviewer's report:
The issue of the medical prevention of post-ERCP pancreatitis (PEP) has been
recently emphasized thanks to updated European (Dumonceau 2014) and
American (Tenner 2013) guidelines. In this study, authors have confirmed the
efficacy of rectal administration of indomethacin for the prevention of PEP in
high-risk patients.
The topic is of great interest, but some methodological problems put aside the
relevance of the results.
The article is presented as a randomized study, but some criticisms can raise
about its prospective design: both the National Clinical Trials identifier number
and the two references used to define the high risk patients were dated April
2014 and 2015, respectively, while the period of enrollment of the patients
started before (from July 2012 to December 2013).
It is also surprising that the informed consent was given from “patients under the
effect of sedative medication” (from line 183 to 188, page 8): the informed
consent was obtained at the end of ERCP (line 184) and after that the
administration of suppositories, thus, with “patients under the effect of sedative
medication” (line 188).
It is not the case to report in the Methods section (page 8 line 179-180) the
“pancreatic fistulas” as an indication for the placement of pancreatic stent
because of the very low rate of a such disease. It should rather be considered as
an exclusion criteria.
In the Methods section, the references to the consensus definition of PEP
(Cotton 2001) and that for the rate of PEP (25%) reported for high risk patients
are not reported (page 9 line 203 and page 10 line 226, respectively).
In the Discussion section the added value of the results of this study in
comparison with those already published is lacking. Furthermore, the discussion
has to be entirely re-written: it is too long and it seems more a review than a
critical analysis of the results of this and other studies.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests.
assistant