Background

and study aims: Endobiliary dysplasia may persist after endoscopic papillectomy. Intraductal radiofrequency ablation (ID-RFA) is a potential alternative to complementary surgery. The aim of the study was to evaluate the efficacy and safety of ID-RFA for the treatment of adenomatous intraductal residue after endoscopic papillectomy.

Patients and methods

A prospective open-label multicenter study included patients with histologically proven endobiliary adenoma remnant (ductal extent <20 mm), after endoscopic papillectomy for ampullary tumor. RFA (effect 8, power 10 Watts, 30s) was performed during ERCP. Biliary ± pancreatic stent was placed at the end of the procedure. Endpoints were (1) the rate of residual neoplasia (ie, low-grade dysplasia-LGD, high-grade dysplasia-HGD, or invasive carcinoma) at 6 and 12 months; (2) rate of surgery, and (3) adverse events.

Results

Twenty patients (67 years (±11), 12 men) were included. The endobiliary adenoma was in LGD in 15 patients, and HGD in 5 patients. All underwent one successful ID-RFA session with biliary stent placement and recovered uneventfully. Five (25%) received a pancreatic stent. The rates of residual neoplasia were 15% and 30% at 6 and 12 months, respectively. Only 2 patients (10%) were referred for surgery. Eight patients (40%) experienced at least 1 adverse event between ID-RFA and 12 months of follow-up. No major adverse event occurred. HGD at inclusion was associated with higher dysplasia recurrence at 12 months (p=0.01).

Conclusions

ID-RFA of residual endobiliary dysplasia after endoscopic papillectomy can be offered as an alternative to surgery, with a 70% chance of dysplasia eradication at 12 months after a single session and a good safety profile. Patient follow-up remains warranted after ID-RFA. ClinicalTrial.gov identifier: NCT02825524

中文翻译：

---

胆道射频消融术根除内镜下乳头状瘤切除术后残留肿瘤的疗效和安全性：一项多中心前瞻性研究

背景

和研究目的：内镜下乳头状瘤切除术后胆道内异常增生可能会持续。导管内射频消融（ID-RFA）是替代手术的潜在替代方法。这项研究的目的是评估ID-RFA在内窥镜乳头切除术后治疗腺瘤性导管内残留的疗效和安全性。

患者和方法

一项前瞻性开放性多中心研究包括经组织学证实的壶腹肿瘤经组织学证实为胆管内腺瘤残留（导管范围<20 mm）的患者。在ERCP期间执行了RFA（效果8，功率10瓦，30秒）。在手术结束时放置胆胰胰支架。终点是（1）在6个月和12个月时残留肿瘤的发生率（即低度不典型增生-LGD，高度不典型增生-HGD或浸润性癌）；（2）手术率，和（3）不良事件。

结果

包括20例患者（67岁（±11），男性12例）。胆道内腺瘤在LGD中有15例，HGD在5例中。所有患者均进行了一次成功的ID-RFA手术，并放置了胆道支架，并且恢复良好。五（25％）人接受了胰支架。在6个月和12个月时，残留瘤形成的比率分别为15％和30％。仅2例患者（10％）被转介做手术。8例（40％）患者在ID-RFA与12个月的随访之间经历了至少1次不良事件。没有发生重大不良事件。纳入时的HGD与12个月时较高的异型增生复发相关（p = 0.01）。

结论

内窥镜乳头切除术后残留的胆管内异型增生的ID-RFA可作为手术的替代方法，单次治疗后12个月有70％的机会根除异型增生，并具有良好的安全性。ID-RFA后仍需对患者进行随访。ClinicalTrial.gov标识符：NCT02825524