Reviewer's report
Title:Management of patients with biliary sphincter of Oddi disorder without
sphincter of Oddi manometry
Version: 1Date:2 August 2010
Reviewer: C Mel Wilcox
Reviewer's report:
Your retrospective study assesses interventions and outcome in patients with
suspected SOD types I-III managed at a single center. The study is potentially
worthwhile as it sheds some light on the efficacy of treatment as well as outcome
of such patients. The study also assesses response following endoscopic
intervention in the absence of using manometry to define the syndrome.
Major Comments
As you accurately state in the “Discussion”, a major limitation is the retrospective
nature of the study and the absence of any rigorous quantitative measure of
abdominal pain. Thus, other than a subjective impression, the response is
difficult to accurately characterize and is a major limitation of the study.
Specific Comments
1. Page 3 – “praxis” should be practice
2. A major emphasis of the paper, both in Background and Discussion, is the lack
of using sphincter of Oddi manometry and using prophylactic pancreatic stents.
However, the manuscript emphasis is on management of these patients without
the use of manometry. Since patients are still undergoing ERCP and treatment at
your center, the discussion and emphasis on ERCP is somewhat superfluous
since these patients are still getting ERCP and are at essentially the same risk of
getting pancreatitis and other complications.
3. Page 5 – Management- specific doses of medications would be important to
know, specifically amitriptyline. Do these patients receive proton pump inhibitors
which would also be important as a diagnostic trial?
4. As noted above, “patients with no satisfactory symptom relief…….” In the
absence of any objective measure this information is difficult to interpret. In
addition, we are not told who made these assessments. Assuming it’s the
physician, then significant bias is likely.
5. Page 6, bottom – if a patient is discharged from the outpatient clinic, one
assumes that they are “cured”. However, were these patients followed long-term
to ensure the absence of any recurrence?
6. Page 7, top – when do these patients develop recurrence of symptoms? And
from what time point are they being measured? After sphincterotomy?
7. Page 7, top – Again, use of complete, improvement, unchanged are very
subjective.
8. In the “Results” section, one must specifically delineate the length and range
of follow-up. A table would be essential to characterize your cohort. You initially
mentioned that a number of patients had an intact gallbladder. This should have
been mentioned in the “Results” section and in your table characterizing these
patients. In addition, at most centers, patients with right upper quadrant pain with
a gallbladder in situ would undergo radionuclide imaging for gallbladder
dyskinesia. While I would agree this is controversial, at most centers in the
United States, ERCP and manometry are not considered unless the patient had
previously undergone cholecystectomy.
9. Page 8 – ERCP was frequently utilized (41%) in your cohort and I wonder why
so many ERCPs were, in fact, performed. As you know, generally if someone
undergoes a complete sphincterotomy, there is no residual biliary pressure in
contrast to the pancreatic sphincter. This has been supported by studies where
patients undergo repeat manometry showing absent sphincter pressures. Indeed
up to 7 ERCPs were required in some patients suggesting excess usage! Why
would biliary stenting be used in patients who had previously undergone
sphincterotomy? Also, if someone has undergone biliary sphincterotomy why
would surgery even be considered? Please define “restenosis”.
10. Page 9 – A number of statistical analyses were performed. Were any of these
pre-planned? Was any statistical test used to control for multiple comparisons?
11. “Discussion” should be reduced by 25%.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Reviewer's report
Title:Management of patients with biliary sphincter of Oddi disorder without
sphincter of Oddi manometry
Version: 1Date:2 August 2010
Reviewer: C Mel Wilcox
Reviewer's report:
Your retrospective study assesses interventions and outcome in patients with
suspected SOD types I-III managed at a single center. The study is potentially
worthwhile as it sheds some light on the efficacy of treatment as well as outcome
of such patients. The study also assesses response following endoscopic
intervention in the absence of using manometry to define the syndrome.
Major Comments
As you accurately state in the “Discussion”, a major limitation is the retrospective
nature of the study and the absence of any rigorous quantitative measure of
abdominal pain. Thus, other than a subjective impression, the response is
difficult to accurately characterize and is a major limitation of the study.
Specific Comments
1. Page 3 – “praxis” should be practice
2. A major emphasis of the paper, both in Background and Discussion, is the lack
of using sphincter of Oddi manometry and using prophylactic pancreatic stents.
However, the manuscript emphasis is on management of these patients without
the use of manometry. Since patients are still undergoing ERCP and treatment at
your center, the discussion and emphasis on ERCP is somewhat superfluous
since these patients are still getting ERCP and are at essentially the same risk of
getting pancreatitis and other complications.
3. Page 5 – Management- specific doses of medications would be important to
know, specifically amitriptyline. Do these patients receive proton pump inhibitors
which would also be important as a diagnostic trial?
4. As noted above, “patients with no satisfactory symptom relief…….” In the
absence of any objective measure this information is difficult to interpret. In
addition, we are not told who made these assessments. Assuming it’s the
physician, then significant bias is likely.
5. Page 6, bottom – if a patient is discharged from the outpatient clinic, one
assumes that they are “cured”. However, were these patients followed long-term
to ensure the absence of any recurrence?
6. Page 7, top – when do these patients develop recurrence of symptoms? And
from what time point are they being measured? After sphincterotomy?
7. Page 7, top – Again, use of complete, improvement, unchanged are very
subjective.
8. In the “Results” section, one must specifically delineate the length and range
of follow-up. A table would be essential to characterize your cohort. You initially
mentioned that a number of patients had an intact gallbladder. This should have
been mentioned in the “Results” section and in your table characterizing these
patients. In addition, at most centers, patients with right upper quadrant pain with
a gallbladder in situ would undergo radionuclide imaging for gallbladder
dyskinesia. While I would agree this is controversial, at most centers in the
United States, ERCP and manometry are not considered unless the patient had
previously undergone cholecystectomy.
9. Page 8 – ERCP was frequently utilized (41%) in your cohort and I wonder why
so many ERCPs were, in fact, performed. As you know, generally if someone
undergoes a complete sphincterotomy, there is no residual biliary pressure in
contrast to the pancreatic sphincter. This has been supported by studies where
patients undergo repeat manometry showing absent sphincter pressures. Indeed
up to 7 ERCPs were required in some patients suggesting excess usage! Why
would biliary stenting be used in patients who had previously undergone
sphincterotomy? Also, if someone has undergone biliary sphincterotomy why
would surgery even be considered? Please define “restenosis”.
10. Page 9 – A number of statistical analyses were performed. Were any of these
pre-planned? Was any statistical test used to control for multiple comparisons?
11. “Discussion” should be reduced by 25%.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Please review this paper.
user
Reviewer's report
Title:Management of patients with biliary sphincter of Oddi disorder without
sphincter of Oddi manometry
Version: 1Date:2 August 2010
Reviewer: C Mel Wilcox
Reviewer's report:
Your retrospective study assesses interventions and outcome in patients with
suspected SOD types I-III managed at a single center. The study is potentially
worthwhile as it sheds some light on the efficacy of treatment as well as outcome
of such patients. The study also assesses response following endoscopic
intervention in the absence of using manometry to define the syndrome.
Major Comments
As you accurately state in the “Discussion”, a major limitation is the retrospective
nature of the study and the absence of any rigorous quantitative measure of
abdominal pain. Thus, other than a subjective impression, the response is
difficult to accurately characterize and is a major limitation of the study.
Specific Comments
1. Page 3 – “praxis” should be practice
2. A major emphasis of the paper, both in Background and Discussion, is the lack
of using sphincter of Oddi manometry and using prophylactic pancreatic stents.
However, the manuscript emphasis is on management of these patients without
the use of manometry. Since patients are still undergoing ERCP and treatment at
your center, the discussion and emphasis on ERCP is somewhat superfluous
since these patients are still getting ERCP and are at essentially the same risk of
getting pancreatitis and other complications.
3. Page 5 – Management- specific doses of medications would be important to
know, specifically amitriptyline. Do these patients receive proton pump inhibitors
which would also be important as a diagnostic trial?
4. As noted above, “patients with no satisfactory symptom relief…….” In the
absence of any objective measure this information is difficult to interpret. In
addition, we are not told who made these assessments. Assuming it’s the
physician, then significant bias is likely.
5. Page 6, bottom – if a patient is discharged from the outpatient clinic, one
assumes that they are “cured”. However, were these patients followed long-term
to ensure the absence of any recurrence?
6. Page 7, top – when do these patients develop recurrence of symptoms? And
from what time point are they being measured? After sphincterotomy?
7. Page 7, top – Again, use of complete, improvement, unchanged are very
subjective.
8. In the “Results” section, one must specifically delineate the length and range
of follow-up. A table would be essential to characterize your cohort. You initially
mentioned that a number of patients had an intact gallbladder. This should have
been mentioned in the “Results” section and in your table characterizing these
patients. In addition, at most centers, patients with right upper quadrant pain with
a gallbladder in situ would undergo radionuclide imaging for gallbladder
dyskinesia. While I would agree this is controversial, at most centers in the
United States, ERCP and manometry are not considered unless the patient had
previously undergone cholecystectomy.
9. Page 8 – ERCP was frequently utilized (41%) in your cohort and I wonder why
so many ERCPs were, in fact, performed. As you know, generally if someone
undergoes a complete sphincterotomy, there is no residual biliary pressure in
contrast to the pancreatic sphincter. This has been supported by studies where
patients undergo repeat manometry showing absent sphincter pressures. Indeed
up to 7 ERCPs were required in some patients suggesting excess usage! Why
would biliary stenting be used in patients who had previously undergone
sphincterotomy? Also, if someone has undergone biliary sphincterotomy why
would surgery even be considered? Please define “restenosis”.
10. Page 9 – A number of statistical analyses were performed. Were any of these
pre-planned? Was any statistical test used to control for multiple comparisons?
11. “Discussion” should be reduced by 25%.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
assistant