Professor of Medicine, Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Gastrointest Endosc. 2018 Jan;87(1):205-210. doi: 10.1016/j.gie.2017.04.015. Epub 2017 Apr 25.
The EPISOD (Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction) study randomized patients with post-cholecystectomy pain, and little or no objective evidence for biliary obstruction, to sphincterotomy or sham intervention. Results at 1 year showed no benefit for the active treatment. We now report the outcomes at up to 5 years.
One hundred three patients completing 1 year, and still blinded to treatment allocation, were enrolled and followed by phone every 6 months for a median of 58 months (range, 17-71 months). Their success was assessed at the final visit by 2 criteria: (1) a low pain score (Recurrent Abdominal Pain and Disability instrument [RAPID] <6) and (2) much or very much improved on the Patients' Global Impression of Change (PGIC) questionnaire (both with no repeat intervention and not taking narcotics).
By the RAPID criteria, success rates for the patients in the sphincterotomy and sham arms were similar: 26/65 (40%) versus 16/38 (42%), respectively. However, by the PGIC criteria, actively treated patients fared worse: 16/43 (37%) versus 16/22 (73%). A total of 75 patients underwent active treatment during the entire study. Their success rate by the RAPID criteria was 31 (41%) compared with 16 (62%) who had no active treatment at any time.
These data confirm our initial report that endoscopic sphincterotomy is no better than sham intervention in these patients (and, by some criteria, worse), and that ERCP can no longer be recommended. The patients have genuine and often severe symptoms, and further research is needed to establish effective management. (Clinical trial registration number: 00688662 05/3/2008.).
EPISOD（Oddi 括约肌功能障碍预测因子和干预措施评估）研究将胆囊切除术后疼痛且几乎没有或没有胆道梗阻客观证据的患者随机分配至行括约肌切开术或假手术。1 年的研究结果显示，活性治疗没有获益。我们现报告最长 5 年的随访结果。
103 例完成 1 年随访且仍对治疗分组保持盲态的患者入组，并通过电话每 6 个月随访 1 次，中位随访时间为 58 个月（范围 17-71 个月）。在最后 1 次随访时，通过 2 项标准评估其治疗效果：（1）低疼痛评分（复发性腹痛和残疾量表[RAPID]＜6）和（2）患者对治疗变化的总体印象（PGIC）问卷上报告“明显改善”或“非常改善”（两者均未再次行介入治疗且未使用麻醉性镇痛药）。
根据 RAPID 标准，括约肌切开术组和假手术组患者的成功率相似：分别为 65 例中的 26 例（40%）和 38 例中的 16 例（42%）。然而，根据 PGIC 标准，积极治疗的患者效果较差：43 例中的 16 例（37%）和 22 例中的 16 例（73%）。共有 75 例患者在整个研究过程中接受了积极治疗。根据 RAPID 标准，他们的成功率为 31 例（41%），而在任何时间均未接受积极治疗的患者中，有 16 例（62%）成功率为 31 例。
这些数据证实了我们最初的报告，即内镜下括约肌切开术与假手术相比在这些患者中并无优势（且在某些标准下，效果更差），并且不能再推荐行 ERCP。这些患者有真正且常常严重的症状，需要进一步研究来确定有效的治疗方法。（临床试验注册号：00688662 05/3/2008）。
