Pilot Randomized Controlled Trial of Laparoscopic Cholecystectomy vs Active Nonoperative Therapy for the Treatment of Biliary Dyskinesia

BACKGROUND: Despite widespread adoption by the surgical community, high-quality prospective data supporting the practice of laparoscopic cholecystectomy (LC) for the treatment of biliary dyskinesia (BD) are lacking. STUDY DESIGN: Adult patients meeting criteria for diagnosis of BD (Rome III symptoms, normal ultrasound, gallbladder ejection fraction <38%) were randomized to either LC or a trial of nonoperative (NO) therapy with a low-dose neuromodulator (amitriptyline 25 mg/day). Patients in the NO arm were allowed to cross over to the surgical arm and remain in the study for any reason. Besides collection of basic demographics and medical/surgical history, patients were administered a standardized quality of life (QOL) assessment (Short Form-8) and a symptom-specific questionnaire (Rome III criteria) at enrollment and monthly through the study to assess the effect of treatment on biliary symptoms and overall QOL. RESULTS: Thirty patients were enrolled over 12 months (15 LC, 15 NO). In the LC group, 13 underwent LC, 1 refused surgery, 1 withdrew. In the NO group, 14 crossed over to the LC group (13 of whom had LC), yielding 26 patients who underwent LC. The SF-8 physical scores (PCS-8) were significantly improved at both the first and last follow-up visits (p < 0.0001, p = 0.0003, respectively). The SF-8 mental scores (MCS-8) were also significantly improved at both the first and last follow-up visits (p = 0.0187, p = 0.0017, respectively). With median follow-up of 12 months (range 3 to 14 months), all 26 reported relief of pain. CONCLUSIONS: This pilot study raises doubts regarding the feasibility of a randomized trial, presumably due to both clinician and patient bias toward LC and the lack of "gold-standard" nonoperative treatments. However, these prospective data indicate that, with careful patient selection (standardized symptom criteria/imaging methodology), LC results in pain relief and significant improvement in QOL in BD patients. Further prospective study of these findings is warranted. ((C) 2016 by the American College of Surgeons. Published by Elsevier Inc. All rights reserved.)