Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction

Peter B. Cotton, Valerie Durkalski, Kyle B. Orrell, Olga Brawman-Mintzer, Douglas A. Drossman, C. Mel Wilcox, Patrick D. Mauldin, Grace H. Elta, Paul R. Tarnasky, Evan Fogel, Sanjay B. Jagganath, Richard A. Kozarek, Martin L. Freeman, Joseph Romagnuolo, Patricia R. Robuck

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background Sphincter of Oddi dysfunction (SOD) is a controversial topic, especially in patients with no objective findings on laboratory or imaging studies (SOD type III). The value of ERCP manometry with sphincterotomy is unproven and carries significant risks. Objective To describe the process of planning and initiating a randomized sham-controlled study to establish whether patients with SOD respond to sphincter ablation, and whether the outcomes are predicted by the pain patterns, presence or absence of other functional GI or psychosocial problems, or the results of manometry. Design Planning a trial to establish which patients with "suspected SOD" (if any) respond to endoscopic sphincter ablation. Setting Meetings and correspondence by a planning group of gastroenterologists and clinical research specialists hosted at the Medical University of South Carolina. Patients Clarifying subject characteristics and inclusion and exclusion criteria. Interventions Defining the questionnaires, therapies, randomizations, and numbers of subjects required by outcome measures. Defining the metrics of success and failure. Results The planning resulted in funding for the proposed study as a cooperative agreement with the National Institute of Diabetes and Digestive and Kidney Diseases. Limitations Lack of data required several consensus decisions in designing the protocol. Conclusion The planning process was challenging, and some changes were needed after initiation. (Clinical trial registration number: NCT00688662.)

Original languageEnglish
Pages (from-to)986-991
Number of pages6
JournalGastrointestinal Endoscopy
Volume72
Issue number5
DOIs
StatePublished - Nov 2010

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Sphincter of Oddi Dysfunction
Manometry
National Institute of Diabetes and Digestive and Kidney Diseases (U.S.)
Endoscopic Retrograde Cholangiopancreatography
Random Allocation
Consensus
Outcome Assessment (Health Care)
Clinical Trials
Pain
Clinical Studies
Research

ASJC Scopus subject areas

  • Gastroenterology
  • Radiology Nuclear Medicine and imaging

Cite this

Cotton, P. B., Durkalski, V., Orrell, K. B., Brawman-Mintzer, O., Drossman, D. A., Wilcox, C. M., ... Robuck, P. R. (2010). Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction. Gastrointestinal Endoscopy, 72(5), 986-991. https://doi.org/10.1016/j.gie.2010.08.022

Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction. / Cotton, Peter B.; Durkalski, Valerie; Orrell, Kyle B.; Brawman-Mintzer, Olga; Drossman, Douglas A.; Wilcox, C. Mel; Mauldin, Patrick D.; Elta, Grace H.; Tarnasky, Paul R.; Fogel, Evan; Jagganath, Sanjay B.; Kozarek, Richard A.; Freeman, Martin L.; Romagnuolo, Joseph; Robuck, Patricia R.

In: Gastrointestinal Endoscopy, Vol. 72, No. 5, 11.2010, p. 986-991.

Research output: Contribution to journalArticle

Cotton, PB, Durkalski, V, Orrell, KB, Brawman-Mintzer, O, Drossman, DA, Wilcox, CM, Mauldin, PD, Elta, GH, Tarnasky, PR, Fogel, E, Jagganath, SB, Kozarek, RA, Freeman, ML, Romagnuolo, J & Robuck, PR 2010, 'Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction', Gastrointestinal Endoscopy, vol. 72, no. 5, pp. 986-991. https://doi.org/10.1016/j.gie.2010.08.022
Cotton PB, Durkalski V, Orrell KB, Brawman-Mintzer O, Drossman DA, Wilcox CM et al. Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction. Gastrointestinal Endoscopy. 2010 Nov;72(5):986-991. https://doi.org/10.1016/j.gie.2010.08.022
Cotton, Peter B. ; Durkalski, Valerie ; Orrell, Kyle B. ; Brawman-Mintzer, Olga ; Drossman, Douglas A. ; Wilcox, C. Mel ; Mauldin, Patrick D. ; Elta, Grace H. ; Tarnasky, Paul R. ; Fogel, Evan ; Jagganath, Sanjay B. ; Kozarek, Richard A. ; Freeman, Martin L. ; Romagnuolo, Joseph ; Robuck, Patricia R. / Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction. In: Gastrointestinal Endoscopy. 2010 ; Vol. 72, No. 5. pp. 986-991.
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AU - Drossman, Douglas A.

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AU - Mauldin, Patrick D.

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AU - Tarnasky, Paul R.

AU - Fogel, Evan

AU - Jagganath, Sanjay B.

AU - Kozarek, Richard A.

AU - Freeman, Martin L.

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N2 - Background Sphincter of Oddi dysfunction (SOD) is a controversial topic, especially in patients with no objective findings on laboratory or imaging studies (SOD type III). The value of ERCP manometry with sphincterotomy is unproven and carries significant risks. Objective To describe the process of planning and initiating a randomized sham-controlled study to establish whether patients with SOD respond to sphincter ablation, and whether the outcomes are predicted by the pain patterns, presence or absence of other functional GI or psychosocial problems, or the results of manometry. Design Planning a trial to establish which patients with "suspected SOD" (if any) respond to endoscopic sphincter ablation. Setting Meetings and correspondence by a planning group of gastroenterologists and clinical research specialists hosted at the Medical University of South Carolina. Patients Clarifying subject characteristics and inclusion and exclusion criteria. Interventions Defining the questionnaires, therapies, randomizations, and numbers of subjects required by outcome measures. Defining the metrics of success and failure. Results The planning resulted in funding for the proposed study as a cooperative agreement with the National Institute of Diabetes and Digestive and Kidney Diseases. Limitations Lack of data required several consensus decisions in designing the protocol. Conclusion The planning process was challenging, and some changes were needed after initiation. (Clinical trial registration number: NCT00688662.)

AB - Background Sphincter of Oddi dysfunction (SOD) is a controversial topic, especially in patients with no objective findings on laboratory or imaging studies (SOD type III). The value of ERCP manometry with sphincterotomy is unproven and carries significant risks. Objective To describe the process of planning and initiating a randomized sham-controlled study to establish whether patients with SOD respond to sphincter ablation, and whether the outcomes are predicted by the pain patterns, presence or absence of other functional GI or psychosocial problems, or the results of manometry. Design Planning a trial to establish which patients with "suspected SOD" (if any) respond to endoscopic sphincter ablation. Setting Meetings and correspondence by a planning group of gastroenterologists and clinical research specialists hosted at the Medical University of South Carolina. Patients Clarifying subject characteristics and inclusion and exclusion criteria. Interventions Defining the questionnaires, therapies, randomizations, and numbers of subjects required by outcome measures. Defining the metrics of success and failure. Results The planning resulted in funding for the proposed study as a cooperative agreement with the National Institute of Diabetes and Digestive and Kidney Diseases. Limitations Lack of data required several consensus decisions in designing the protocol. Conclusion The planning process was challenging, and some changes were needed after initiation. (Clinical trial registration number: NCT00688662.)

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