Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial
Introduction Treatment for abdominal pain in patients with chronic pancreatitis (CP) remains challenging in the setting of central nervous system sensitisation, a phenomenon of remodelling and neuronal hyperexcitability resulting from persistent pain stimuli. This is suspected to render affected ind...
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BMJ Publishing Group
2024-03-01
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| Online Access: | https://bmjopen.bmj.com/content/14/3/e081505.full |
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| author | Adam Slivka Rohit Das Asbjørn Mohr Drewes Søren Schou Olesen Mouen A Khashab Vikesh K Singh Dhiraj Yadav Mahya Faghih Anna Evans Phillips Elham Afghani Venkata Sandeep Akshintala Panayiotis Y Benos Jeffrey Easler Charles Gabbert Vivek Halappa Jami L Saloman Biatta Sholosh Tianxiu Wang |
| author_facet | Adam Slivka Rohit Das Asbjørn Mohr Drewes Søren Schou Olesen Mouen A Khashab Vikesh K Singh Dhiraj Yadav Mahya Faghih Anna Evans Phillips Elham Afghani Venkata Sandeep Akshintala Panayiotis Y Benos Jeffrey Easler Charles Gabbert Vivek Halappa Jami L Saloman Biatta Sholosh Tianxiu Wang |
| author_sort | Adam Slivka |
| collection | DOAJ |
| description | Introduction Treatment for abdominal pain in patients with chronic pancreatitis (CP) remains challenging in the setting of central nervous system sensitisation, a phenomenon of remodelling and neuronal hyperexcitability resulting from persistent pain stimuli. This is suspected to render affected individuals less likely to respond to conventional therapies. Endotherapy or surgical decompression is offered to patients with pancreatic duct obstruction. However, the response to treatment is unpredictable. Pancreatic quantitative sensory testing (P-QST), an investigative technique of standardised stimulations to test the pain system in CP, has been used for phenotyping patients into three mutually exclusive groups: no central sensitisation, segmental sensitisation (pancreatic viscerotome) and widespread hyperalgesia suggestive of supraspinal central sensitisation. We will test the predictive capability of the pretreatment P-QST phenotype to predict the likelihood of pain improvement following invasive treatment for painful CP.Methods and analysis This observational clinical trial will enrol 150 patients from the University of Pittsburgh, Johns Hopkins and Indiana University. Participants will undergo pretreatment phenotyping with P-QST. Treatment will be pancreatic endotherapy or surgery for clearance of painful pancreatic duct obstruction. Primary outcome: average pain score over the preceding 7 days measured by Numeric Rating Scale at 6 months postintervention. Secondary outcomes will include changes in opioid use during follow-up, and patient-reported outcomes in pain and quality of life at 3, 6 and 12 months after the intervention. Exploratory outcomes will include creation of a model for individualised prediction of response to invasive treatment.Ethics and dissemination The trial will evaluate the ability of P-QST to predict response to invasive treatment for painful CP and develop a predictive model for individualised prediction of treatment response for widespread use. This trial was approved by the University of Pittsburgh Institutional Review Board. Data and results will be reported and disseminated in conjunction with National Institutes of Health policies.Trial registration number NCT04996628. |
| format | Article |
| id | doaj-art-e4cd25da4e174f66bf5ed04a09297663 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-e4cd25da4e174f66bf5ed04a092976632025-08-20T03:12:43ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2023-081505Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trialAdam Slivka0Rohit Das1Asbjørn Mohr Drewes2Søren Schou Olesen3Mouen A Khashab4Vikesh K Singh5Dhiraj Yadav6Mahya Faghih7Anna Evans Phillips8Elham Afghani9Venkata Sandeep Akshintala10Panayiotis Y Benos11Jeffrey Easler12Charles Gabbert13Vivek Halappa14Jami L Saloman15Biatta Sholosh16Tianxiu Wang1711 Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADivision of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USAMech-Sense, Department of Gastroenterology, Aalborg University Hospital, Aalborg, DenmarkCentre for Pancreatic Diseases and Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, DenmarkDivision of Gastroenterology and Hepatology, Johns Hopkins Medical Institute, Baltimore, Maryland, USADivision of Gastroenterology and Hepatology, Johns Hopkins Medical Institute, Baltimore, Maryland, USADivision of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USADivision of Gastroenterology and Hepatology, Johns Hopkins Medical Institute, Baltimore, Maryland, USA6 Department of Medicine, Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburg, Pittsburg, Pennsylvania, USADivision of Gastroenterology and Hepatology, Johns Hopkins Medical Institute, Baltimore, Maryland, USADivision of Gastroenterology and Hepatology, Johns Hopkins Medical Institute, Baltimore, Maryland, USADepartment of Epidemiology, University of Florida, Gainesville, Florida, USADivision of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USADivision of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USADivision of Radiology, Indiana University School of Medicine, Indianapolis, Indiana, USADivision of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USADivision of Radiology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USACenter for Research on Healthcare Data, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USAIntroduction Treatment for abdominal pain in patients with chronic pancreatitis (CP) remains challenging in the setting of central nervous system sensitisation, a phenomenon of remodelling and neuronal hyperexcitability resulting from persistent pain stimuli. This is suspected to render affected individuals less likely to respond to conventional therapies. Endotherapy or surgical decompression is offered to patients with pancreatic duct obstruction. However, the response to treatment is unpredictable. Pancreatic quantitative sensory testing (P-QST), an investigative technique of standardised stimulations to test the pain system in CP, has been used for phenotyping patients into three mutually exclusive groups: no central sensitisation, segmental sensitisation (pancreatic viscerotome) and widespread hyperalgesia suggestive of supraspinal central sensitisation. We will test the predictive capability of the pretreatment P-QST phenotype to predict the likelihood of pain improvement following invasive treatment for painful CP.Methods and analysis This observational clinical trial will enrol 150 patients from the University of Pittsburgh, Johns Hopkins and Indiana University. Participants will undergo pretreatment phenotyping with P-QST. Treatment will be pancreatic endotherapy or surgery for clearance of painful pancreatic duct obstruction. Primary outcome: average pain score over the preceding 7 days measured by Numeric Rating Scale at 6 months postintervention. Secondary outcomes will include changes in opioid use during follow-up, and patient-reported outcomes in pain and quality of life at 3, 6 and 12 months after the intervention. Exploratory outcomes will include creation of a model for individualised prediction of response to invasive treatment.Ethics and dissemination The trial will evaluate the ability of P-QST to predict response to invasive treatment for painful CP and develop a predictive model for individualised prediction of treatment response for widespread use. This trial was approved by the University of Pittsburgh Institutional Review Board. Data and results will be reported and disseminated in conjunction with National Institutes of Health policies.Trial registration number NCT04996628.https://bmjopen.bmj.com/content/14/3/e081505.full |
| spellingShingle | Adam Slivka Rohit Das Asbjørn Mohr Drewes Søren Schou Olesen Mouen A Khashab Vikesh K Singh Dhiraj Yadav Mahya Faghih Anna Evans Phillips Elham Afghani Venkata Sandeep Akshintala Panayiotis Y Benos Jeffrey Easler Charles Gabbert Vivek Halappa Jami L Saloman Biatta Sholosh Tianxiu Wang Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial BMJ Open |
| title | Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial |
| title_full | Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial |
| title_fullStr | Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial |
| title_full_unstemmed | Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial |
| title_short | Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial |
| title_sort | pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction study protocol for an observational clinical trial |
| url | https://bmjopen.bmj.com/content/14/3/e081505.full |
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