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A randomized trial comparing endoscopic stenting to a sham procedure for chronic pancreatitis

Department of Medicine, Division of Gastroenterology and Hepatology, University of Alabama at Birmingham, Birmingham, AL, United States, melw{at}uab.edu

Tercio L Lopes

Department of Medicine, Division of Gastroenterology and Hepatology, University of Alabama at Birmingham, Birmingham, AL, United States

Background A number of studies support the use of endoscopically placed pancreatic duct (PD) stents to decrease pain in chronic pancreatitis (CP). Nevertheless, flaws in study design have prevented experts from reaching a consensus.

Purpose (1) Evaluate the efficacy of PD stenting to ameliorate abdominal pain in patients with CP and ductal strictures; (2) evaluate the placebo response rate from sham endoscopic therapy; (3) compare pain medication usage, healthcare utilization, psychological distress, and quality of life before and after endoscopic stenting; (4) prospectively evaluate the durability of the response.

Methods Patients with typical abdominal pain, imaging confirmation of CP and endoscopic retrograde cholangiopancreatography (ERCP) confirmation of PD stricture will complete questionnaires to assess quality of life, psychological distress, pain intensity/unpleasantness, pain medication usage, and healthcare utilization. Enrolled patients will be randomized to ERCP with sphincterotomy and PD stenting versus sham procedure. Pain level and medication usage will be assessed weekly with telephone interviews. At 6—8 weeks, patients treated with stents will undergo stent removal; those randomized to the sham procedure without significant improvement (<50% reduction in pain score) will cross over to the treatment group; and those randomized to sham procedure who experienced improvement (>50% reduction) will be followed clinically. Patients will be followed in clinic or by phone biannually (up to 3 years). The primary endpoint is improvement in abdominal pain. The secondary endpoints are reduction in narcotic use, healthcare utilization, and work days missed; return to employment; improvement in quality of life and weight gain.

Results Proposed study.

Limitations Strict inclusion criteria may limit enrollment.

Conclusion The proposed study represents the first trial of endoscopic stenting for symptomatic CP and ductal strictures with a credible sham procedure, assessment of multiple dimensions of pain, and psychosocial factors. Clinical Trials 2009; 6: 455—463. http://ctj.sagepub.com

This version was published on October 1, 2009

Clinical Trials, Vol. 6, No. 5, 455-463 (2009)
DOI: 10.1177/1740774509338230


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