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Optimizing pancreatectomy outcomes: Follow the evidence
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 1 ( 2 0 1 3 ) 2 1 3 e2 1 5
Available online at www.sciencedirect.com
journal homepage: www.JournalofSurgicalResearch.com
Commentary
Optimizing pancreatectomy outcomes: Follow the evidence James John Mezhir, MD* Department of Surgery, Division of Surgical Oncology and Endocrine Surgery, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 4642-JCP, Iowa City, Iowa 52242
article info Article history: Received 8 February 2012 Received in revised form 9 February 2012 Accepted 17 February 2012 Available online 10 March 2012
A PubMed search of “pancreatectomy” reveals 10,376 articles, and a fraction of these represent randomized controlled trials (n ¼ 81) [1]. The number of randomized trials performed to date by surgeons to optimize outcomes in pancreatic resection is remarkable. Some of the recent major trials are shown in Table 1. These trials form the basis for many discussions on teaching rounds and include some of the most debatable topics in surgical Morbidity and Mortality conference, such as the routine use of intraperitoneal drains and when to remove them, preoperative biliary drainage, the use of pancreatic stents, intraoperative fluid restriction, preoperative biliary stent versus no drainage, or how to close the pancreatic stump. Operative outcomes continue to improve with the implementation of evidence-based approaches to patient care, better perioperative management, and of course patient selection. We are also seeing a significant improvement in complications reporting, which enables us to critically evaluate studies and broaden their application to our own practices [2]. Despite the many published trials, there are a few hurdles to successful implementation. A lack of expertise in performing a new technique (i.e., invagination for pancreaticojejunostomy) may prevent some surgeons from
applying a novel finding in the literature to their individual patient. Additionally, most surgeons will admit that personal biases/preferences may prevent them from implementing new findings to their clinical practice (i.e., I have always left a drain so why would I change?). Some interventions, however, that have proven beneficial to patients cannot be left to surgeon preference. An example of this includes the use of routine deep venous thrombosis prophylaxis because of the high risk of thromboembolism in this patient population [3]. A challenge that is faced by many centers is finding an ideal way to implement evidence-based care into the operating room and surgical ward. In addition to the implementation of better reporting of preventable complications (American College of Surgeons National Surgical Quality Improvement Program) [4], one potential solution includes the use of medical or surgical care bundles (SCBs). Care bundles are being reported with increased frequency and most notably in an effort to reduce central line infections [5]. Dr. Yeo’s group from Thomas Jefferson University recently published their experience with implementation of a perioperative SCB in an attempt to reduce complications associated with pancreaticoduodenectomy [6]. Their retrospective cohort study compared two groups of
DOI of original article: 10.1016/j.jss.2011.09.028. * Corresponding author. Department of Surgery, Division of Surgical Oncology and Endocrine Surgery, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 4642-JCP, Iowa City, Iowa 52242. Tel.: þ1 319 384 5124; fax: þ1 319 353 8940. E-mail address: [email protected]. 0022-4804/$ e see front matter ª 2013 Elsevier Inc. All rights reserved. doi:10.1016/j.jss.2012.02.038
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j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 1 ( 2 0 1 3 ) 2 1 3 e2 1 5
Table 1 e Recent randomized controlled trials in pancreatectomy outcomes. Variable
Study, year
Randomization
PBD
van der Gaag et al., 2010 [8]
PBD versus surgery alone
Anastomotic technique Pancreatic stump closure Duration of intraperitoneal drainage
Berger et al., 2009 [9]
Invagination versus duct to mucosa anastomosis for pancreaticojejunostomy Hand sewn versus stapler after distal pancreatectomy Early drain removal (POD 3) versus late drain removal (POD 5)
Diener et al., 2011 [10] Bassi et al., 2010 [11]
Pancreatic stent
Pessaux et al., 2011 [12]
External pancreatic stent versus no stent
Intraoperative fluid management
Fischer et al., 2010 [13]
Acute normovolemic hemodilution versus standard fluid management
Outcome 46% complication rate from PBD procedures performed preoperatively No difference in operative complications Statistically significant decrease in fistula rate in invagination group No difference in pancreatic fistula or operative mortality Significant reduction in pancreatic fistulae, overall complications, and hospital stay and associated costs in early drain removal group Significant decrease in pancreatic fistulae, wound infections, and delayed gastric emptying in stented group No difference in transfusions between groups Hemodilution group had a significant increase in pancreatic anastomotic complications likely because of increased fluid administration
PBD ¼ Preoperative biliary drainage; POD = Post-operative day.
patientsdthose that were treated from October 2005 to May 2008 (n ¼ 233) without the SCB and those that were treated from May 2008 to May 2010 (n ¼ 233) after implementation of the SCB. The 12 measures in the SCB are shown in Table 2. The authors astutely highlight some of the limitations of their study in the Discussion so they will not be mentioned here in detail. Of note, despite the SCB measures being implemented, the impact on the specific interventions was not measured (i.e., glucose measurements, patient temperature, or a documentation of compliance with the SCB). Also, preoperative biliary drainage, a critical preoperative factor associated with infectious complications, was not available. Irrespective of this, in comparison with the control (pre-SCB) group, wound infections were significantly lower (7.7% compared with 15.0%, P ¼ 0.01). Overall postoperative morbidity and other complications, such as fistula/leak/ abscess, delayed gastric emptying, or deep venous thrombosis, were equivalent between groups. There also was no difference in mortality, hospital stay, or 30-d readmission.
Table 2 e Twelve-measure SCB implemented at Thomas Jefferson University from 2008 to 2010 [6]. 1 2 3 4 5 6 7 8 9 10 11 12
Absence of remote infection Preoperative smoking cessation Preadmission chlorhexidineealcohol skin preparation Preoperative clipper hair removal Preoperative chlorhexidineealcohol skin preparation Preoperative antibiotic administration Intraoperative wound edge protection Intraoperative glycemic control Intraoperative temperature control Gown and glove change before skin closure Deep venous thrombosis prophylaxis and b-blocker administration Pre and postoperative briefings
Despite only finding a difference in one critical parameter, the successful implementation of an SCB is remarkable. At a high volume institution with multiple surgeons, developing and executing a protocol successfully that impacted patient care is a triumph for Dr. Yeo’s group. Clearly this is the start of something good. Studies like this can potentially lead the way toward more significant improvements in complications, such as pancreatic fistula that will significantly impact patient outcomes. However, it is equally important to note that most patients who have this operation performed are being treated for pancreatic adenocarcinoma (44.6% in this series). Despite the efforts to improve the operation, it will ultimately be the disease that prevails and we should continue to focus our efforts on the biology of this cancer in addition to improving our operative outcomes [7].
references
[1] Available at: http://www.ncbi.nlm.nih.gov/pubmed. Accessed Feb 8, 2012. [2] Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: An international study group (ISGPF) definition. Surgery 2005;138:8. [3] Agnelli G, Bolis G, Capussotti L, et al. A clinical outcome-based prospective study on venous thromboembolism after cancer surgery: The @RISTOS project. Ann Surg 2006;243:89. [4] Kelly KJ, Greenblatt DY, Wan Y, et al. Risk stratification for distal pancreatectomy utilizing ACS-NSQIP: Preoperative factors predict morbidity and mortality. J Gastrointest Surg 2011;15:250. discussion 9. [5] Furuya EY, Dick A, Perencevich EN, et al. Central line bundle implementation in US intensive care units and impact on bloodstream infections. PLoS One 2011;6: e15452. [6] Lavu H, Klinge MJ, Nowcid LJ, et al. Perioperative surgical care bundle reduces pancreaticoduodenectomy wound infections. J Surg Res 2012;174:215.
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 1 ( 2 0 1 3 ) 2 1 3 e2 1 5
[7] Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011;364:1817. [8] van der Gaag NA, Rauws EA, van Eijck CH, et al. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med 2010;362:129. [9] Berger AC, Howard TJ, Kennedy EP, et al. Does type of pancreaticojejunostomy after pancreaticoduodenectomy decrease rate of pancreatic fistula? A randomized, prospective, dual-institution trial. J Am Coll Surg 2009;208: 738. discussion 47. [10] Diener MK, Seiler CM, Rossion I, et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): A randomised, controlled multicentre trial. Lancet 2011;377:1514.
215
[11] Bassi C, Molinari E, Malleo G, et al. Early versus late drain removal after standard pancreatic resections: Results of a prospective randomized trial. Ann Surg 2010; 252:207. [12] Pessaux P, Sauvanet A, Mariette C, et al. External pancreatic duct stent decreases pancreatic fistula rate after pancreaticoduodenectomy: Prospective multicenter randomized trial. Ann Surg 2011;253:879. [13] Fischer M, Matsuo K, Gonen M, et al. Relationship between intraoperative fluid administration and perioperative outcome after pancreaticoduodenectomy: Results of a prospective randomized trial of acute normovolemic hemodilution compared with standard intraoperative management. Ann Surg 2010; 252:952.
Available online at www.sciencedirect.com
journal homepage: www.JournalofSurgicalResearch.com
Commentary
Optimizing pancreatectomy outcomes: Follow the evidence James John Mezhir, MD* Department of Surgery, Division of Surgical Oncology and Endocrine Surgery, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 4642-JCP, Iowa City, Iowa 52242
article info Article history: Received 8 February 2012 Received in revised form 9 February 2012 Accepted 17 February 2012 Available online 10 March 2012
A PubMed search of “pancreatectomy” reveals 10,376 articles, and a fraction of these represent randomized controlled trials (n ¼ 81) [1]. The number of randomized trials performed to date by surgeons to optimize outcomes in pancreatic resection is remarkable. Some of the recent major trials are shown in Table 1. These trials form the basis for many discussions on teaching rounds and include some of the most debatable topics in surgical Morbidity and Mortality conference, such as the routine use of intraperitoneal drains and when to remove them, preoperative biliary drainage, the use of pancreatic stents, intraoperative fluid restriction, preoperative biliary stent versus no drainage, or how to close the pancreatic stump. Operative outcomes continue to improve with the implementation of evidence-based approaches to patient care, better perioperative management, and of course patient selection. We are also seeing a significant improvement in complications reporting, which enables us to critically evaluate studies and broaden their application to our own practices [2]. Despite the many published trials, there are a few hurdles to successful implementation. A lack of expertise in performing a new technique (i.e., invagination for pancreaticojejunostomy) may prevent some surgeons from
applying a novel finding in the literature to their individual patient. Additionally, most surgeons will admit that personal biases/preferences may prevent them from implementing new findings to their clinical practice (i.e., I have always left a drain so why would I change?). Some interventions, however, that have proven beneficial to patients cannot be left to surgeon preference. An example of this includes the use of routine deep venous thrombosis prophylaxis because of the high risk of thromboembolism in this patient population [3]. A challenge that is faced by many centers is finding an ideal way to implement evidence-based care into the operating room and surgical ward. In addition to the implementation of better reporting of preventable complications (American College of Surgeons National Surgical Quality Improvement Program) [4], one potential solution includes the use of medical or surgical care bundles (SCBs). Care bundles are being reported with increased frequency and most notably in an effort to reduce central line infections [5]. Dr. Yeo’s group from Thomas Jefferson University recently published their experience with implementation of a perioperative SCB in an attempt to reduce complications associated with pancreaticoduodenectomy [6]. Their retrospective cohort study compared two groups of
DOI of original article: 10.1016/j.jss.2011.09.028. * Corresponding author. Department of Surgery, Division of Surgical Oncology and Endocrine Surgery, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 4642-JCP, Iowa City, Iowa 52242. Tel.: þ1 319 384 5124; fax: þ1 319 353 8940. E-mail address: [email protected]. 0022-4804/$ e see front matter ª 2013 Elsevier Inc. All rights reserved. doi:10.1016/j.jss.2012.02.038
214
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 1 ( 2 0 1 3 ) 2 1 3 e2 1 5
Table 1 e Recent randomized controlled trials in pancreatectomy outcomes. Variable
Study, year
Randomization
PBD
van der Gaag et al., 2010 [8]
PBD versus surgery alone
Anastomotic technique Pancreatic stump closure Duration of intraperitoneal drainage
Berger et al., 2009 [9]
Invagination versus duct to mucosa anastomosis for pancreaticojejunostomy Hand sewn versus stapler after distal pancreatectomy Early drain removal (POD 3) versus late drain removal (POD 5)
Diener et al., 2011 [10] Bassi et al., 2010 [11]
Pancreatic stent
Pessaux et al., 2011 [12]
External pancreatic stent versus no stent
Intraoperative fluid management
Fischer et al., 2010 [13]
Acute normovolemic hemodilution versus standard fluid management
Outcome 46% complication rate from PBD procedures performed preoperatively No difference in operative complications Statistically significant decrease in fistula rate in invagination group No difference in pancreatic fistula or operative mortality Significant reduction in pancreatic fistulae, overall complications, and hospital stay and associated costs in early drain removal group Significant decrease in pancreatic fistulae, wound infections, and delayed gastric emptying in stented group No difference in transfusions between groups Hemodilution group had a significant increase in pancreatic anastomotic complications likely because of increased fluid administration
PBD ¼ Preoperative biliary drainage; POD = Post-operative day.
patientsdthose that were treated from October 2005 to May 2008 (n ¼ 233) without the SCB and those that were treated from May 2008 to May 2010 (n ¼ 233) after implementation of the SCB. The 12 measures in the SCB are shown in Table 2. The authors astutely highlight some of the limitations of their study in the Discussion so they will not be mentioned here in detail. Of note, despite the SCB measures being implemented, the impact on the specific interventions was not measured (i.e., glucose measurements, patient temperature, or a documentation of compliance with the SCB). Also, preoperative biliary drainage, a critical preoperative factor associated with infectious complications, was not available. Irrespective of this, in comparison with the control (pre-SCB) group, wound infections were significantly lower (7.7% compared with 15.0%, P ¼ 0.01). Overall postoperative morbidity and other complications, such as fistula/leak/ abscess, delayed gastric emptying, or deep venous thrombosis, were equivalent between groups. There also was no difference in mortality, hospital stay, or 30-d readmission.
Table 2 e Twelve-measure SCB implemented at Thomas Jefferson University from 2008 to 2010 [6]. 1 2 3 4 5 6 7 8 9 10 11 12
Absence of remote infection Preoperative smoking cessation Preadmission chlorhexidineealcohol skin preparation Preoperative clipper hair removal Preoperative chlorhexidineealcohol skin preparation Preoperative antibiotic administration Intraoperative wound edge protection Intraoperative glycemic control Intraoperative temperature control Gown and glove change before skin closure Deep venous thrombosis prophylaxis and b-blocker administration Pre and postoperative briefings
Despite only finding a difference in one critical parameter, the successful implementation of an SCB is remarkable. At a high volume institution with multiple surgeons, developing and executing a protocol successfully that impacted patient care is a triumph for Dr. Yeo’s group. Clearly this is the start of something good. Studies like this can potentially lead the way toward more significant improvements in complications, such as pancreatic fistula that will significantly impact patient outcomes. However, it is equally important to note that most patients who have this operation performed are being treated for pancreatic adenocarcinoma (44.6% in this series). Despite the efforts to improve the operation, it will ultimately be the disease that prevails and we should continue to focus our efforts on the biology of this cancer in addition to improving our operative outcomes [7].
references
[1] Available at: http://www.ncbi.nlm.nih.gov/pubmed. Accessed Feb 8, 2012. [2] Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: An international study group (ISGPF) definition. Surgery 2005;138:8. [3] Agnelli G, Bolis G, Capussotti L, et al. A clinical outcome-based prospective study on venous thromboembolism after cancer surgery: The @RISTOS project. Ann Surg 2006;243:89. [4] Kelly KJ, Greenblatt DY, Wan Y, et al. Risk stratification for distal pancreatectomy utilizing ACS-NSQIP: Preoperative factors predict morbidity and mortality. J Gastrointest Surg 2011;15:250. discussion 9. [5] Furuya EY, Dick A, Perencevich EN, et al. Central line bundle implementation in US intensive care units and impact on bloodstream infections. PLoS One 2011;6: e15452. [6] Lavu H, Klinge MJ, Nowcid LJ, et al. Perioperative surgical care bundle reduces pancreaticoduodenectomy wound infections. J Surg Res 2012;174:215.
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 1 ( 2 0 1 3 ) 2 1 3 e2 1 5
[7] Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011;364:1817. [8] van der Gaag NA, Rauws EA, van Eijck CH, et al. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med 2010;362:129. [9] Berger AC, Howard TJ, Kennedy EP, et al. Does type of pancreaticojejunostomy after pancreaticoduodenectomy decrease rate of pancreatic fistula? A randomized, prospective, dual-institution trial. J Am Coll Surg 2009;208: 738. discussion 47. [10] Diener MK, Seiler CM, Rossion I, et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): A randomised, controlled multicentre trial. Lancet 2011;377:1514.
215
[11] Bassi C, Molinari E, Malleo G, et al. Early versus late drain removal after standard pancreatic resections: Results of a prospective randomized trial. Ann Surg 2010; 252:207. [12] Pessaux P, Sauvanet A, Mariette C, et al. External pancreatic duct stent decreases pancreatic fistula rate after pancreaticoduodenectomy: Prospective multicenter randomized trial. Ann Surg 2011;253:879. [13] Fischer M, Matsuo K, Gonen M, et al. Relationship between intraoperative fluid administration and perioperative outcome after pancreaticoduodenectomy: Results of a prospective randomized trial of acute normovolemic hemodilution compared with standard intraoperative management. Ann Surg 2010; 252:952.