698
Morgan et al
Discussion
potentially poor coping with a debilitating disease state. Postoperatively, these patients had similar QOL improvements to 1 year follow-up. Mean physQOL scores at 2 and 3 years follow-up, however, were higher in patients demonstrating at-risk behavior for opioid misuse than in patients without opioid misuse behaviors. Careful evaluation of the COMM is worthwhile in understanding these results.10 Positive responses to many of the questions could be indicative of poor pain control rather than the more ominous and complex implications of opioid misuse. For example, the test asks “In the past 30 days, how often have you had to go to someone other than your prescribing physician to get sufficient pain relief from medications (ie, the emergency room)?” “In the past 30 days how often have you taken your medications differently from how they are prescribed?” “In the past 30 days, how often have you had to make an emergency phone call or show up at the clinic without an appointment?” “In the past 30 days, how often have you had to take more of your medication than prescribed?” and “In the past 30 days how often have you had to visit the emergency room?” A high score on the COMM might be an indicator of a more severe or more difficult to control pain diathesis that would be more likely to respond to intervention rather than maladaptive behavior.
CONCLUSIONS Behavioral therapy is effective in the treatment of chronic illness associated with pain disorders.9 Behavioral health care and support is an essential component of the management of the CP patient undergoing TPIAT. Psychometric testing is valuable in assessing specific patient behaviors and needs and remains an important component of preoperative evaluation and postoperative management of TPIAT patients. This analysis, unfortunately, did not identify a psychometric screening test to reliably predict outcomes in patients undergoing TPIAT. Data from this study, however, do not negate the impact and value of preoperative and postoperative behavioral therapy in TPAIT patients. Author Contributions Study conception and design: Morgan, Adams Acquisition of data: Morgan, Borckardt, Balliet, Owczarski, Adams Analysis and interpretation of data: Morgan, Borckardt, Balliet, Adams Drafting of manuscript: Morgan, Borckardt, Balliet, Adams Critical revision: Morgan, Borckardt, Balliet, Adams
J Am Coll Surg
REFERENCES 1. Demir IE, Tieftrunk E, Maak M, et al. Pain mechanisms in chronic pancreatitis: of a master and his fire. Langenbecks Arch Surg 2011;396:151e160. 2. Barth KS, Balliet W, Pelic CM, et al. Screening for current opioid misuse and associated risk factors among patients with chronic nonalcoholic pancreatitis pain. Pain Med 2014; 15:1359e1364. 3. Morgan K, Owczarski SM, Borckardt J, et al. Pain control and quality of life after pancreatectomy with islet autotransplantation for chronic pancreatitis. J Gastrointest Surg 2012;16: 129e134. 4. Sutherland DE, Radosevich DM, Bellin MD, et al. Total pancreatectomy and islet autotransplantation for chronic pancreatitis. J Am Coll Surg 2012;214:409e424. 5. Argo JL, Contreras JL, Wesley MM, Christein JD. Pancreatic resection with islet cell autotransplant for the treatment of severe chronic pancreatitis. Am Surg 2008;74:530e536. 6. Rilo HR, Ahmad SA, D’Alessio D. Total pancreatectomy and autologous islet cell transplant as a means to treat severe chronic pancreatitis. J Gastrointest Surg 2003;7: 978e989. 7. Everhart JE, Ruhl CE. Burden of digestive diseases in the United States Part III: liver, biliary tract, and pancreas. Gastroenterology 2009;136:1134e1144. 8. Brook RH, Ware JE Jr, Rogers WH, et al. Does free care improve adults’ health? Results from a randomized controlled trial. N Engl J Med 1983;309:1426e1434. 9. Madan A, Borckardt JJ, Barth KS, et al. Interprofessional collaborative care reduces excess service utilization among individuals with chronic pancreatitis. J Healthc Qual 2013;35: 41e46. 10. Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the current opioid misuse measure. Pain 2007;130:144e156.
Discussion DR JOHN CHRISTEIN (Birmingham, AL): Dr Morgan, your group at the Medical University of South Carolina (MUSC) have cultivated a robust islet autotransplantation program with very high volume. I have followed your work, discussed other manuscripts, and you have excellent operative outcomes. That is why this paper is so important to the pancreatectomy and islet autotransplant field. In this manuscript, you dive into the indications, which we have all been circling around for several years, and try to determine which patients do best and whether there is any way we can predict this upfront. I would like to commend you on your dedication to the multidisciplinary team that you use to diagnose, recommend a treatment strategy, and follow up with patients over the years. As we all know, chronic pancreatitis patients have a worse quality of life than heartand kidney-failure patients. There is much more to their treatment than simply removing the pancreas and putting some cells back in the liver.
Vol. 220, No. 4, April 2015
We are all learning and realizing, with more and more quality of life studies, that insulin freedom is great but true chronic pancreatitis patients have much worse problems than diabetes. A few questions: 1. In your analysis of the opioid use of the patients, were you able to make any correlation about: A. Duration of use before operation? B. Type of narcotic used, ie codeine vs oxycodone vs methadone, improvement in quality of life and depression, and time-to-improvement after operation? C. The subset of those patients who wean off narcotics quickly, say within 6 months, do they tend to have a better and more durable improvement in quality of life and depression scores? I know this is not preoperative, but maybe it can give us an early postoperative impression of who is going to struggle. 2. Were you able to look more into the psychological history, meaning were any patients treated clinically or pharmacologically before operation? Did they do better or worse? 3. Was there a difference in recovery in the total vs completion pancreatectomy group? Should we just always be doing total upfront? 4. How about etiology? Does your small group of alcoholic patients do worse? How does smoking play a role? 5. How can we do it better? Should some patients have to undergo preoperative psychological therapy for a period of time before operation? Are there any patients to whom you say “no,” based on poor preoperative scores?
DR STEVEN J HUGHES (Gainesville, FL): For someone who takes care of this disease process on a regular basis, nothing looks better from the outside than taking the whole thing out and performing an islet transplantation. One would hope that it would address one of the causes of pain, which a drainage procedure or partial resection cannot do. One would hope that it would reduce the morbidity of the operation by eliminating the risk of pancreatic fistula. Unfortunately, your data show what others have, which is that this operation is not perfect. Therefore, it is actually very appropriate to investigate whether we can identify patients preoperatively who truly will benefit from this very complicated procedure. In that context, I have 2 questions for you, in general categories. The first is that about 40% of your patients actually have the diagnosis of sphincter of Oddi dysfunction. This is a complicated diagnosis, and a diagnosis with many questions. How do you diagnose this condition in your institution? How do you interpret the impact of a recent study that showed that sphincterotomy vs sham endoscopy had no difference in outcomes? Do you think this is a group of patients whom you should continue to treat with this particular procedure? Do you have any genetic testing information in this subset of patients or the idiopathic group of patients? The second general concept is regarding the duration of disability. I think it is very important when you talk about psychometric issues, that these patients are referred to a surgeon when their
Morgan et al
Discussion
699
gastroenterologist has just run out of anything to offer them. They have been ill for some period of time. Can you enlighten us with any information with respect to the duration of disability of your patients? Have you been able to show any correlation between how long these patients have been ill and their overall response to this surgical treatment? DR KATY MORGAN: First, Dr Christein, we did look at the duration of opioid use. Really, in our database, it is duration of disease, but I assume it correlates with duration of narcotic use. We have found that it does not actually correlate with outcomes in terms of quality of life, but it does correlate with insulin independence. The longer that they have had disease, the less likely they are to be insulin-independent after surgery. You asked about the different specific types of narcotics. In our database, we convert everything into morphine equivalence. I am not able to go back and look at that, although I suppose we could with chart review. But, again, it’s not readily available in the database. I have my own personal preferences for what I think is harder to wean, but that is obviously not very scientific. To evaluate narcotic weaning and the ease of weaning, we actually separated our patients into patients who were successful narcotic weaners and those who failed narcotic weaning, and tried to look at differences between the 2 groups. Again, postoperatively long-term, we did not find any difference in outcomes in terms of quality of life. We did, however, find that patients who failed to wean well from narcotics did have a decreased preoperative psychological quality of life. So it is a certain patient type, I guess. In terms of the psychiatric history of these patients, that is part of the comprehensive behavioral medicine evaluation that they all undergo preoperatively. We leave it to our behavioral health psychologists. Sometimes they bring in the psychiatrist who works with them to determine whether someone has had adequate treatment and whether they are ready for surgery, so to speak. We are not directly involved in that determination, but, obviously, it is a big part of some of our discussions. We think it is an important part. We will have a treatment plan and follow-up for some of the higher risk patients. Dr Hughes, in terms of the sphincter of Oddi dysfunction questions, which I think are very good ones, first you mentioned Episode trial, which is a large multi-institutional NIH trial that recently came out. Our institution was the lead institution; the study looked at patients with postcholecystectomy pain who did not have any objective evidence of disease; they just had pain. They did not have elevated liver enzymes or abnormalities on imaging. Importantly, the study excluded patients with evidence of pancreatitis. That is a very different group of patients than what we are dealing with here. By definition, patients in our study had chronic pancreatitis. Having said that, our institution does draw a lot of patients with that label of sphincter of Oddi dysfunction. That is why when I present my etiology data, I prefer not to use the word “etiology” because that implies causation. Instead, I use the term “risk factor,” because our patients are brought to us with that diagnosis. Many of them have been treated for sphincter of Oddi dysfunction for several years. So, again, not to imply causation.
700
Morgan et al
Discussion
Looking at outcomes, though, the sphincter of Oddi dysfunction patients do not have different outcomes than the other patients in the group. If we look at the different etiology groups of our patients, the only patient group that seems to have different outcomes are our genetic patients. Patients with hereditary pancreatitis clearly have much better outcomes than our other patients. Probably only in the past year or so, I would guess, we have started routinely testing these patients for genetic factors as
J Am Coll Surg
contributory to their pancreatitis. I do not have great volumes of data on genetic testing on everyone, but I would suspect if we did that on the sphincter of Oddi dysfunction group, we would find some of that in that group. I agree with you on that. Finally, in terms of earlier intervention and duration of disability, again, as I said, it seems the longer you have disease, the less likely you are to be insulin-independent.
Morgan et al
Discussion
potentially poor coping with a debilitating disease state. Postoperatively, these patients had similar QOL improvements to 1 year follow-up. Mean physQOL scores at 2 and 3 years follow-up, however, were higher in patients demonstrating at-risk behavior for opioid misuse than in patients without opioid misuse behaviors. Careful evaluation of the COMM is worthwhile in understanding these results.10 Positive responses to many of the questions could be indicative of poor pain control rather than the more ominous and complex implications of opioid misuse. For example, the test asks “In the past 30 days, how often have you had to go to someone other than your prescribing physician to get sufficient pain relief from medications (ie, the emergency room)?” “In the past 30 days how often have you taken your medications differently from how they are prescribed?” “In the past 30 days, how often have you had to make an emergency phone call or show up at the clinic without an appointment?” “In the past 30 days, how often have you had to take more of your medication than prescribed?” and “In the past 30 days how often have you had to visit the emergency room?” A high score on the COMM might be an indicator of a more severe or more difficult to control pain diathesis that would be more likely to respond to intervention rather than maladaptive behavior.
CONCLUSIONS Behavioral therapy is effective in the treatment of chronic illness associated with pain disorders.9 Behavioral health care and support is an essential component of the management of the CP patient undergoing TPIAT. Psychometric testing is valuable in assessing specific patient behaviors and needs and remains an important component of preoperative evaluation and postoperative management of TPIAT patients. This analysis, unfortunately, did not identify a psychometric screening test to reliably predict outcomes in patients undergoing TPIAT. Data from this study, however, do not negate the impact and value of preoperative and postoperative behavioral therapy in TPAIT patients. Author Contributions Study conception and design: Morgan, Adams Acquisition of data: Morgan, Borckardt, Balliet, Owczarski, Adams Analysis and interpretation of data: Morgan, Borckardt, Balliet, Adams Drafting of manuscript: Morgan, Borckardt, Balliet, Adams Critical revision: Morgan, Borckardt, Balliet, Adams
J Am Coll Surg
REFERENCES 1. Demir IE, Tieftrunk E, Maak M, et al. Pain mechanisms in chronic pancreatitis: of a master and his fire. Langenbecks Arch Surg 2011;396:151e160. 2. Barth KS, Balliet W, Pelic CM, et al. Screening for current opioid misuse and associated risk factors among patients with chronic nonalcoholic pancreatitis pain. Pain Med 2014; 15:1359e1364. 3. Morgan K, Owczarski SM, Borckardt J, et al. Pain control and quality of life after pancreatectomy with islet autotransplantation for chronic pancreatitis. J Gastrointest Surg 2012;16: 129e134. 4. Sutherland DE, Radosevich DM, Bellin MD, et al. Total pancreatectomy and islet autotransplantation for chronic pancreatitis. J Am Coll Surg 2012;214:409e424. 5. Argo JL, Contreras JL, Wesley MM, Christein JD. Pancreatic resection with islet cell autotransplant for the treatment of severe chronic pancreatitis. Am Surg 2008;74:530e536. 6. Rilo HR, Ahmad SA, D’Alessio D. Total pancreatectomy and autologous islet cell transplant as a means to treat severe chronic pancreatitis. J Gastrointest Surg 2003;7: 978e989. 7. Everhart JE, Ruhl CE. Burden of digestive diseases in the United States Part III: liver, biliary tract, and pancreas. Gastroenterology 2009;136:1134e1144. 8. Brook RH, Ware JE Jr, Rogers WH, et al. Does free care improve adults’ health? Results from a randomized controlled trial. N Engl J Med 1983;309:1426e1434. 9. Madan A, Borckardt JJ, Barth KS, et al. Interprofessional collaborative care reduces excess service utilization among individuals with chronic pancreatitis. J Healthc Qual 2013;35: 41e46. 10. Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the current opioid misuse measure. Pain 2007;130:144e156.
Discussion DR JOHN CHRISTEIN (Birmingham, AL): Dr Morgan, your group at the Medical University of South Carolina (MUSC) have cultivated a robust islet autotransplantation program with very high volume. I have followed your work, discussed other manuscripts, and you have excellent operative outcomes. That is why this paper is so important to the pancreatectomy and islet autotransplant field. In this manuscript, you dive into the indications, which we have all been circling around for several years, and try to determine which patients do best and whether there is any way we can predict this upfront. I would like to commend you on your dedication to the multidisciplinary team that you use to diagnose, recommend a treatment strategy, and follow up with patients over the years. As we all know, chronic pancreatitis patients have a worse quality of life than heartand kidney-failure patients. There is much more to their treatment than simply removing the pancreas and putting some cells back in the liver.
Vol. 220, No. 4, April 2015
We are all learning and realizing, with more and more quality of life studies, that insulin freedom is great but true chronic pancreatitis patients have much worse problems than diabetes. A few questions: 1. In your analysis of the opioid use of the patients, were you able to make any correlation about: A. Duration of use before operation? B. Type of narcotic used, ie codeine vs oxycodone vs methadone, improvement in quality of life and depression, and time-to-improvement after operation? C. The subset of those patients who wean off narcotics quickly, say within 6 months, do they tend to have a better and more durable improvement in quality of life and depression scores? I know this is not preoperative, but maybe it can give us an early postoperative impression of who is going to struggle. 2. Were you able to look more into the psychological history, meaning were any patients treated clinically or pharmacologically before operation? Did they do better or worse? 3. Was there a difference in recovery in the total vs completion pancreatectomy group? Should we just always be doing total upfront? 4. How about etiology? Does your small group of alcoholic patients do worse? How does smoking play a role? 5. How can we do it better? Should some patients have to undergo preoperative psychological therapy for a period of time before operation? Are there any patients to whom you say “no,” based on poor preoperative scores?
DR STEVEN J HUGHES (Gainesville, FL): For someone who takes care of this disease process on a regular basis, nothing looks better from the outside than taking the whole thing out and performing an islet transplantation. One would hope that it would address one of the causes of pain, which a drainage procedure or partial resection cannot do. One would hope that it would reduce the morbidity of the operation by eliminating the risk of pancreatic fistula. Unfortunately, your data show what others have, which is that this operation is not perfect. Therefore, it is actually very appropriate to investigate whether we can identify patients preoperatively who truly will benefit from this very complicated procedure. In that context, I have 2 questions for you, in general categories. The first is that about 40% of your patients actually have the diagnosis of sphincter of Oddi dysfunction. This is a complicated diagnosis, and a diagnosis with many questions. How do you diagnose this condition in your institution? How do you interpret the impact of a recent study that showed that sphincterotomy vs sham endoscopy had no difference in outcomes? Do you think this is a group of patients whom you should continue to treat with this particular procedure? Do you have any genetic testing information in this subset of patients or the idiopathic group of patients? The second general concept is regarding the duration of disability. I think it is very important when you talk about psychometric issues, that these patients are referred to a surgeon when their
Morgan et al
Discussion
699
gastroenterologist has just run out of anything to offer them. They have been ill for some period of time. Can you enlighten us with any information with respect to the duration of disability of your patients? Have you been able to show any correlation between how long these patients have been ill and their overall response to this surgical treatment? DR KATY MORGAN: First, Dr Christein, we did look at the duration of opioid use. Really, in our database, it is duration of disease, but I assume it correlates with duration of narcotic use. We have found that it does not actually correlate with outcomes in terms of quality of life, but it does correlate with insulin independence. The longer that they have had disease, the less likely they are to be insulin-independent after surgery. You asked about the different specific types of narcotics. In our database, we convert everything into morphine equivalence. I am not able to go back and look at that, although I suppose we could with chart review. But, again, it’s not readily available in the database. I have my own personal preferences for what I think is harder to wean, but that is obviously not very scientific. To evaluate narcotic weaning and the ease of weaning, we actually separated our patients into patients who were successful narcotic weaners and those who failed narcotic weaning, and tried to look at differences between the 2 groups. Again, postoperatively long-term, we did not find any difference in outcomes in terms of quality of life. We did, however, find that patients who failed to wean well from narcotics did have a decreased preoperative psychological quality of life. So it is a certain patient type, I guess. In terms of the psychiatric history of these patients, that is part of the comprehensive behavioral medicine evaluation that they all undergo preoperatively. We leave it to our behavioral health psychologists. Sometimes they bring in the psychiatrist who works with them to determine whether someone has had adequate treatment and whether they are ready for surgery, so to speak. We are not directly involved in that determination, but, obviously, it is a big part of some of our discussions. We think it is an important part. We will have a treatment plan and follow-up for some of the higher risk patients. Dr Hughes, in terms of the sphincter of Oddi dysfunction questions, which I think are very good ones, first you mentioned Episode trial, which is a large multi-institutional NIH trial that recently came out. Our institution was the lead institution; the study looked at patients with postcholecystectomy pain who did not have any objective evidence of disease; they just had pain. They did not have elevated liver enzymes or abnormalities on imaging. Importantly, the study excluded patients with evidence of pancreatitis. That is a very different group of patients than what we are dealing with here. By definition, patients in our study had chronic pancreatitis. Having said that, our institution does draw a lot of patients with that label of sphincter of Oddi dysfunction. That is why when I present my etiology data, I prefer not to use the word “etiology” because that implies causation. Instead, I use the term “risk factor,” because our patients are brought to us with that diagnosis. Many of them have been treated for sphincter of Oddi dysfunction for several years. So, again, not to imply causation.
700
Morgan et al
Discussion
Looking at outcomes, though, the sphincter of Oddi dysfunction patients do not have different outcomes than the other patients in the group. If we look at the different etiology groups of our patients, the only patient group that seems to have different outcomes are our genetic patients. Patients with hereditary pancreatitis clearly have much better outcomes than our other patients. Probably only in the past year or so, I would guess, we have started routinely testing these patients for genetic factors as
J Am Coll Surg
contributory to their pancreatitis. I do not have great volumes of data on genetic testing on everyone, but I would suspect if we did that on the sphincter of Oddi dysfunction group, we would find some of that in that group. I agree with you on that. Finally, in terms of earlier intervention and duration of disability, again, as I said, it seems the longer you have disease, the less likely you are to be insulin-independent.
