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期刊来源：Ann Intern Med

原文链接：https://doi.org/10.7326/M24-0210

摘要内容如下：

背景

尚无随机对照试验证实内镜下胰管减压术治疗疼痛性慢性胰腺炎。

客观

探讨胰管减压对慢性胰腺炎伴胰管内结石患者的止痛效果。

设计

24周，平行组，随机对照试验（ClinicalTrials.gov：NCT03966781）。

设置

2021年2月至2022年7月在印度的亚洲胃肠病研究所。

参与者

106例慢性胰腺炎患者。

干预

体外冲击波碎石术（ESWL）联合内镜逆行胰管造影术（ERP）与假手术的比较。

测量

主要终点是12周时0-10分视觉模拟评分（VAS）的疼痛缓解。在12周和24周后评估次要结果，包括30%疼痛缓解、阿片类药物使用、无痛日、问卷调查和干预并发症。

结果

ESWL/ERP组52例，假手术组54例。在12周时，ESWL/ERP组显示出比假手术组更好的疼痛缓解（VAS的变化的平均差异，-0.7[95%CI，-1.3至0]；P=0.039）。在24周的随访中，两组之间的差异没有持续，在12周或24周的随访中，30%的疼痛缓解没有差异。在12周的随访中，与假手术组相比，ESWL/ERP组的无疼痛天数增加（中位数差异，16.2天[CI，3.9至28.5天]），使用阿片类药物的天数减少（中位数差异，-5.4天[CI，-9.9至-0.9天]）。两组的安全性结果相似。

局限性

单中心研究和有限的随访时间。

结论

在慢性胰腺炎和导管内结石患者中，ESWL联合ERP可适度缓解短期疼痛。

主要资金来源

亚洲胃肠病学研究所和奥尔堡大学医院。

英文原文如下：

Abstracts

BACKGROUND  No randomized controlled trials have substantiated endoscopic decompression of the pancreatic duct in patients with painful chronic pancreatitis.

OBJECTIVE  To investigate the pain-relieving effect of pancreatic duct decompression in patients with chronic pancreatitis and intraductal stones.

DESIGN  24-week, parallel-group, randomized controlled trial (ClinicalTrials.gov: NCT03966781).

SETTING  Asian Institute of Gastroenterology in India from February 2021 to July 2022.

PARTICIPANTS  106 patients with chronic pancreatitis.

INTERVENTION  Combined extracorporeal shock-wave lithotripsy (ESWL) and endoscopic retrograde pancreatography (ERP) compared with sham procedures.

MEASUREMENTS  The primary end point was pain relief on a 0- to 10-point visual analog scale (VAS) at 12 weeks. Secondary outcomes were assessed after 12 and 24 weeks and included 30% pain relief, opioid use, pain-free days, questionaries, and complications to interventions.

RESULTS  52 patients in the ESWL/ERP group and 54 in the sham group were included. At 12 weeks, the ESWL/ERP group showed better pain relief compared with the sham group (mean difference in change, -0.7 [95% CI, -1.3 to 0] on the VAS; P = 0.039). The difference between groups was not sustained at the 24-week follow-up, and no differences were seen for 30% pain relief at 12- or 24-week follow-up. The number of pain-free days was increased (median difference, 16.2 days [CI, 3.9 to 28.5 days]), and the number of days using opioids was reduced (median difference, -5.4 days [CI, -9.9 to -0.9 days]) in the ESWL/ERP group compared with the sham group at 12-week follow-up. Safety outcomes were similar between groups.

LIMITATION  Single-center study and limited duration of follow-up.

CONCLUSION  In patients with chronic pancreatitis and intraductal stones, ESWL with ERP provided modest short-term pain relief.

PRIMARY FUNDING SOURCE  Asian Institute of Gastroenterology and Aalborg University Hospital.

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