Randomized Controlled Trial of Liberal Versus Restricted Fluid Management in Patients Undergoing Pancreatectomy: Erratum

Randomized Controlled Trial of Liberal Versus Restricted Fluid Management in Patients Undergoing... ERRATUM Randomized Controlled Trial of Liberal Versus Restricted Fluid Management in Patients Undergoing Pancreatectomy: Erratum In an article published in the October 2016 issue of Annals of Surgery, a portion of the article was omitted. DR. CHARLES J. YEO (Philadelphia, PA): I rise to congratulate Drs. Grant, Brennan, Allen and others from Memorial Sloan Kettering for organizing and performing this marvelous study and for adding to the growing literature regarding what on the surface would appear to be a very simple and straightforward question, that is, what is the appropriate amount and type of fluid to give a patient intraoperatively and perioperatively in the setting of complex pancreatic surgery? This question has been debated for decades. The waters have become a bit muddled. There have been hemodilution strategies utilized, there have been hypertonic fluid strategies utilized, and, in fact, the term ‘‘permissive oliguria’’ has actually been introduced into practice, which makes some senior surgeons quiver. Overall, this is a very well done study with the caveat that one can always quibble and challenge various decisions made in organizing and designing a randomized control trial. In essence, these authors sought to study a population of pancreatectomy patients, randomized between a liberal arm (that is 12 ml/kg/hr) versus a restricted arm (that is 6 ml/kg/hr), and then assessed for standard post-operative complications. An appropriate CONSORT diagram is given, a total of 330 patients were randomized after resectability was established, the operations were done in short periods of time, and the outcomes are excellent. The study groups were very comparable to other institution’s populations, in that approximately 60% of patients underwent resection for adenocarcinoma, and only about a third of the patients had undergone preoperative biliary stenting. The overall rate of grade 3 complications is laudable, the 30 day readmission rate is only 19%, the reoperation rate was low, and the 60 day mortality rate was <1%. Excellent outcomes. Bravo! Now, for a few questions: Number one. Normosol was chosen as the fluid of choice for both groups. Normosol is essentially a generic version of plasmalyte. Both differ a bit from Ringer’s lactate. Murray, can you please discuss your choice of Normosol? In some situations it can be significantly more disruptive of acid base equilibrium than Ringer’s lactate because it’s composed of sodium gluconate with its attendant inability to generate bicarbonate, so why Normosol, and does it matter? Number 2. I’m curious about including in your cohort not only Whipple patients but also distal pancreatectomy patients, the latter of which may have been done open, laparoscopically, or robotically. In the manuscript, there was no subgroup analysis of Whipple patients alone. I think many in the audience would argue that the postoperative physiology of Whipple patients is often very different from the postoperative physiology of distal pancreatectomy patients. Please comment and address the issue of whether a subgroup analysis for Whipple patients alone was performed. If so, does it have a sample size adequate to prove equivalence or non inferiority between the two groups? Third, please provide some clarity regarding the definitions of various complications used in the study. For many, the ISGPS definitions for pancreas related complications such as fistula, DGE and hemorrhage have been standard. Are there minor differences between the ISGPS and the MSKCC definitions? Or are there important differences? Fourth, an interesting subtlety of your patient population is that one third received prophylactic octreotide or pasireotide the latter as part of the New England Journal reported prospective randomized trial and 75% of the patients undergoing pancreatectomy did not have perioperative drainage. We have talked about this earlier this morning. Perhaps this latter practice contributes to the observation of a relatively high percentage, 20% of your patients requiring post op IR interventions. Is it your contention that the prophylactic somatostatin inhibitor use and lack of drainage are beneficial, or might they have contributed to confound the analysis of your data? Let me say lastly, from a personal perspective, it’s wonderful to be on the other side of the stage from Dr. Brennan. I feel as if I have been given the opportunity to throw him a few softballs. I remember at this very meeting several times in the past Murray drilled fastballs right at my head, tough questions, tough questions, but fair questions. They were right in the strike zone, they were fair and to the point. Thank you, Dr. Brennan, for your many contributions to surgical science, and thanks to the American Surgical Association for the opportunity to discuss this paper. REFERENCE 1. Grant F, Brennan MF, Allen PJ, et al. Prospective Randomized Controlled Trial of Liberal Vs Restricted Perioperative Fluid Management in Patients Undergoing Pancreatectomy. Ann Surg. 264:4;591–598. Annals of Surgery  Volume 267, Number 3, March 2018 www.annalsofsurgery.com | e61 Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Annals of Surgery Wolters Kluwer Health

Randomized Controlled Trial of Liberal Versus Restricted Fluid Management in Patients Undergoing Pancreatectomy: Erratum

Annals of Surgery , Volume 267 (3) – Mar 1, 2018
Free
1 page

Loading next page...
1 Page
 
/lp/wolters_kluwer/randomized-controlled-trial-of-liberal-versus-restricted-fluid-iCh6JyjG5y
Publisher
Wolters Kluwer Health
Copyright
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
ISSN
0003-4932
eISSN
1528-1140
D.O.I.
10.1097/SLA.0000000000002261
Publisher site
See Article on Publisher Site

Abstract

ERRATUM Randomized Controlled Trial of Liberal Versus Restricted Fluid Management in Patients Undergoing Pancreatectomy: Erratum In an article published in the October 2016 issue of Annals of Surgery, a portion of the article was omitted. DR. CHARLES J. YEO (Philadelphia, PA): I rise to congratulate Drs. Grant, Brennan, Allen and others from Memorial Sloan Kettering for organizing and performing this marvelous study and for adding to the growing literature regarding what on the surface would appear to be a very simple and straightforward question, that is, what is the appropriate amount and type of fluid to give a patient intraoperatively and perioperatively in the setting of complex pancreatic surgery? This question has been debated for decades. The waters have become a bit muddled. There have been hemodilution strategies utilized, there have been hypertonic fluid strategies utilized, and, in fact, the term ‘‘permissive oliguria’’ has actually been introduced into practice, which makes some senior surgeons quiver. Overall, this is a very well done study with the caveat that one can always quibble and challenge various decisions made in organizing and designing a randomized control trial. In essence, these authors sought to study a population of pancreatectomy patients, randomized between a liberal arm (that is 12 ml/kg/hr) versus a restricted arm (that is 6 ml/kg/hr), and then assessed for standard post-operative complications. An appropriate CONSORT diagram is given, a total of 330 patients were randomized after resectability was established, the operations were done in short periods of time, and the outcomes are excellent. The study groups were very comparable to other institution’s populations, in that approximately 60% of patients underwent resection for adenocarcinoma, and only about a third of the patients had undergone preoperative biliary stenting. The overall rate of grade 3 complications is laudable, the 30 day readmission rate is only 19%, the reoperation rate was low, and the 60 day mortality rate was <1%. Excellent outcomes. Bravo! Now, for a few questions: Number one. Normosol was chosen as the fluid of choice for both groups. Normosol is essentially a generic version of plasmalyte. Both differ a bit from Ringer’s lactate. Murray, can you please discuss your choice of Normosol? In some situations it can be significantly more disruptive of acid base equilibrium than Ringer’s lactate because it’s composed of sodium gluconate with its attendant inability to generate bicarbonate, so why Normosol, and does it matter? Number 2. I’m curious about including in your cohort not only Whipple patients but also distal pancreatectomy patients, the latter of which may have been done open, laparoscopically, or robotically. In the manuscript, there was no subgroup analysis of Whipple patients alone. I think many in the audience would argue that the postoperative physiology of Whipple patients is often very different from the postoperative physiology of distal pancreatectomy patients. Please comment and address the issue of whether a subgroup analysis for Whipple patients alone was performed. If so, does it have a sample size adequate to prove equivalence or non inferiority between the two groups? Third, please provide some clarity regarding the definitions of various complications used in the study. For many, the ISGPS definitions for pancreas related complications such as fistula, DGE and hemorrhage have been standard. Are there minor differences between the ISGPS and the MSKCC definitions? Or are there important differences? Fourth, an interesting subtlety of your patient population is that one third received prophylactic octreotide or pasireotide the latter as part of the New England Journal reported prospective randomized trial and 75% of the patients undergoing pancreatectomy did not have perioperative drainage. We have talked about this earlier this morning. Perhaps this latter practice contributes to the observation of a relatively high percentage, 20% of your patients requiring post op IR interventions. Is it your contention that the prophylactic somatostatin inhibitor use and lack of drainage are beneficial, or might they have contributed to confound the analysis of your data? Let me say lastly, from a personal perspective, it’s wonderful to be on the other side of the stage from Dr. Brennan. I feel as if I have been given the opportunity to throw him a few softballs. I remember at this very meeting several times in the past Murray drilled fastballs right at my head, tough questions, tough questions, but fair questions. They were right in the strike zone, they were fair and to the point. Thank you, Dr. Brennan, for your many contributions to surgical science, and thanks to the American Surgical Association for the opportunity to discuss this paper. REFERENCE 1. Grant F, Brennan MF, Allen PJ, et al. Prospective Randomized Controlled Trial of Liberal Vs Restricted Perioperative Fluid Management in Patients Undergoing Pancreatectomy. Ann Surg. 264:4;591–598. Annals of Surgery  Volume 267, Number 3, March 2018 www.annalsofsurgery.com | e61 Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

Journal

Annals of SurgeryWolters Kluwer Health

Published: Mar 1, 2018

References

You’re reading a free preview. Subscribe to read the entire article.


DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Search

Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly

Organize

Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.

Access

Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

DeepDyve

Freelancer

DeepDyve

Pro

Price

FREE

$49/month
$360/year

Save searches from
Google Scholar,
PubMed

Create lists to
organize your research

Export lists, citations

Read DeepDyve articles

Abstract access only

Unlimited access to over
18 million full-text articles

Print

20 pages / month

PDF Discount

20% off