Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction - 24/08/11

Doi : 10.1016/j.gie.2010.08.022

Peter B. Cotton, MD, FRCP, FRCS ^a,^⁎, Valerie Durkalski, PhD, MPH ^b, Kyle B. Orrell, MSHP, ACRP ^c, Olga Brawman-Mintzer, MD ^d, Douglas A. Drossman, MD ^e, C. Mel Wilcox, MD ^f, Patrick D. Mauldin, PhD ^g, Grace H. Elta, MD ^h, Paul R. Tarnasky, MD ⁱ, Evan L. Fogel, MD, MSc, FRCPC ^j, Sanjay B. Jagganath, MD ^k, Richard A. Kozarek, MD ^l, Martin L. Freeman, MD ^m, Joseph Romagnuolo, MD, FRCPC, MScEpid ⁿ, Patricia R. Robuck, PhD, MPH ^o
^a Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA.
^b Digestive Disease Center, Division of Biometry and Epidemiology, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
^c Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA.
^d Anxiety Disorders Program, Medical University of South Carolina, Charleston, South Carolina, USA.
^e Center for Functional GI and Motility Disorders, University of North Carolina, Chapel Hill, North Carolina, USA.
^f Division of Gastroenterology, University of Alabama, Birmingham, Alabama, USA.
^g Department of Clinical Pharmacy and Outcome Studies, South Carolina College of Pharmacy, Medical University of South Carolina, Charleston, South Carolina, USA.
^h Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan, USA.
ⁱ Methodist Dallas Medical Center, Dallas, Texas, USA.
^j Division of Gastroenterology and Hepatology, Indiana University Medical Center, Indianapolis, Indiana, USA.
^k Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, USA.
^l Virginia Mason Medical Center, Seattle, Washington, USA.
^m Division of Gastroenterology, Hepatology and Nutrition, University of Minnesota Medical Center, Minneapolis, Minnesota, USA.
ⁿ Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA.
^o Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.

Reprint requests: Peter B. Cotton, MD, FRCP, FRCS, Division of Gastroenterology and Hepatology, Medical University of South Carolina, 25 Courtenay Drive, ART 7100A, MSC 290, Charleston, SC 29425

Riassunto

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.

Subsequent progress: by late September 2010, 102 subjects had been randomized and a further 40 entered into EPISOD 2.

(Clinical trial registration number: NCT00688662.)

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations : RAPID, SOD, SOM

Mappa

	DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. Research support for this study was provided by the National Institute of Diabetes and Digestive and Kidney Diseases, grant U01DK074739.
	If you would like to chat with an author of this article, you may contact Dr Cotton at cottonp@musc.edu.

Esportazione

Vol 72 - N° 5

P. 986-991 - novembre 2010 Ritorno al numero

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