Objective: To preliminarily investigate the clinical outcomes of secondary loop electrosurgical excision procedure (LEEP) combined with transcervical resection of endocervical tissue (i.e., second combined surgeries) in patients with positive endocervical margins following the initial LEEP for high-grade squamous intraepithelial lesion (HSIL) or adenocarcinoma in situ (AIS) of the cervix. Methods: Patients who underwent second combined surgeries due to positive endocervical margins after the initial LEEP for cervical HSIL or AIS at Obstetrics and Gynecology Hospital, Fudan University between August 2015 and September 2023 were included. Postoperative cytological examinations, high-risk human papillomavirus (HR-HPV) testing, colposcopic biopsy results, and cervical canal length were followed up to evaluate the clinical efficacy of second combined surgeries. Results: (1) General clinical data: a total of 67 patients were enrolled, including 34 with cervical HSIL (HSIL group) and 33 with AIS (AIS group). In the HSIL group before the time of initial LEEP, the mean age was (41.3±5.3) years, with all patients positive for HR-HPV preoperatively. Preoperative cytology results revealed ≤low-grade squamous intraepithelial lesion (LSIL) in 13 cases and ≥HSIL in 21 cases. The preoperative cervical canal length was (3.71±0.17) cm. Patients in the AIS group before their the first LEEP were at an average age of (39.1±8.7) years old, with preoperative HR-HPV positive. Among them, 16 cases showed preoperative cytological results of ≤LSIL, while 17 cases showed ≥HSIL. The preoperative cervical canal length was (3.64±0.21) cm. (2) Pathological findings and postoperative follow-up of the HSIL group following second combined surgeries:in the HSIL group, the residual rate of HSIL in the endocervical canal tissue (ECT) was 24% (8/34). Out of the 34 HSIL patients, 10 cases (29%, 10/34) remained with positive endocervical margins post-second combined surgeries. Among these 10 patients, 5 cases (5/10) had no lesion detected in ECT, while the remaining 5 cases (5/10) exhibited HSIL in their ECT. Conversely, 24 patients (71%, 24/34) had negative endocervical margins after second combined surgeries. Of these 24 patients, 3 cases (12%, 3/24) were found to have HSIL in ECT, and 21 cases (88%, 21/24) had no lesion in ECT. During follow-ups conducted at 6 and 12 months post-second combined surgeries, the clearance rates of HR-HPV were 91% (31/34) and 100% (34/34), respectively. Notably, among the 29 patients (85%, 29/34) who were followed up for a period of 2 years or longer, all cases maintained a consistently negative HR-HPV status, highlighting the effectiveness of second combined surgeries in achieving long-term HR-HPV clearance (100%, 29/29). (3) Pathological findings and postoperative follow-up of the AIS group following second combined surgeries: the residual rate of AIS in the ECT following second combined surgeries among AIS patients was 15% (5/33). Out of the 33 AIS patients, 11 cases (33%, 11/33) had positive endocervical margins post-operation, among whom AIS was detected in the ECT of 2 cases (2/11), while 1 case (1/11) was diagnosed with adenocarcinoma in the cervical canal tissue (subsequently underwent radical surgery and was excluded from this study). In contrast, 22 patients (67%, 22/33) had negative endocervical margins post-operation, with AIS found in the ECT of 2 cases (9%, 2/22) and no lesions detected in the remaining 20 cases (91%, 20/22). Follow-up evaluations conducted at 6 and 12 months postoperatively revealed HR-HPV clearance rates of 91% (29/32) and 97% (31/32), respectively. All 32 (100%, 32/32) AIS patients were followed up for a duration of ≥2 years post-second combined surgeries, during which HR-HPV remained consistently negative. (4) Complications and cervical length following second combined surgeries: neither the HSIL group nor the AIS group experienced significant complications such as hemorrhage, infection or cervical canal adhesion. At the 6-month follow-up, the cervical length of both HSIL and AIS patients exceeded 3 cm. By the 12-month follow-up, the cervical length had recovered to 96.5% and 97.5% when compared to the original length, respectively, for the HSIL and AIS groups. Conclusions: For patients with HSIL or AIS who exhibit positive endocervical margins following the initial LEEP procedure, undergoing second combined surgeries presents as an optimal choice. This surgical intervention guarantees thorough excision of the lesion, and subsequent colposcopic follow-up evaluations consistently demonstrate an absence of residual disease or recurrence. Moreover, it augments the rate of sustained HR-HPV negativity, thereby contributing to more favorable clinical outcomes.
目的： 初步探讨二次子宫颈环形电切（LEEP）术联合宫腔镜下子宫颈管电切术（即二次联合手术）治疗子宫颈高级别鳞状上皮内病变（HSIL）和原位腺癌（AIS）首次LEEP术后内切缘阳性患者的临床效果。 方法： 选择2015年8月—2023年9月复旦大学附属妇产科医院宫颈与阴道早期疾病诊疗中心因子宫颈HSIL、AIS行首次LEEP术后内切缘阳性再行二次联合手术且术后随访1年以上的患者，对其二次联合手术后的细胞学检查、高危型人乳头状瘤病毒（HR-HPV）检测、阴道镜定期活检结果、子宫颈管长度进行随访，评估二次联合手术的临床效果。 结果： （1）一般临床资料：本研究共纳入患者67例，其中子宫颈HSIL 34例（HSIL组）、AIS 33例（AIS组）。HSIL组患者首次LEEP术时年龄为（41.3±5.3）岁，术前HR-HPV检查均阳性，术前细胞学结果≤低级别鳞状上皮内病变（LSIL）13例、≥HSIL 21例，术前子宫颈管长度为（3.71±0.17）cm；AIS组患者首次LEEP术时年龄为（39.1±8.7）岁，术前HR-HPV检测均阳性，术前细胞学结果≤LSIL 16例、≥HSIL 17例，术前子宫颈管长度为（3.64±0.21）cm。（2）HSIL组二次联合手术及术后HR-HPV转阴情况：HSIL组患者二次联合手术后子宫颈管HSIL残留率为24%（8/34）。34例HSIL组患者中，二次联合手术后仍为内切缘阳性者10例（29%，10/34），其中5例（5/10）子宫颈管无病灶、5例（5/10）子宫颈管为HSIL；二次联合手术后内切缘阴性者24例（71%，24/34），其中3例（12%，3/24）子宫颈管存在HSIL、21例（88%，21/24）子宫颈管无病灶。术后6、12个月时随访，细胞学检查、阴道镜下子宫颈活检均正常；HR-HPV转阴率分别为91%（31/34）和100%（34/34），其中29例（85%，29/34）随访时间≥2年患者的HR-HPV均持续阴性（100%，29/29）。（3）AIS组二次联合手术及术后HR-HPV转阴情况：AIS组患者二次联合手术后子宫颈管中AIS残留（包括进展为浸润性癌）率为15%（5/33）。33例AIS组患者中，二次联合手术后仍为内切缘阳性者11例（33%，11/33），其中2例（2/11）子宫颈管发现AIS、1例（1/11）子宫颈管诊断为腺癌（后续行根治性手术退出本研究）；二次联合手术后内切缘阴性者22例（67%，22/33），其中2例（9%，2/22）子宫颈管存在AIS、20例（91%，20/22）子宫颈管无病灶。术后6、12个月时随访，细胞学检查、阴道镜下子宫颈活检均正常；HR-HPV转阴率分别为91%（29/32）和97%（31/32），32例（100%，32/32）AIS组患者术后随访时间均≥2年且HR-HPV持续阴性。（4）二次联合手术后并发症及子宫颈长度：HSIL组、AIS组患者二次联合手术后均未出现大出血、感染及子宫颈管粘连等并发症。术后6个月随访时HSIL组、AIS组患者的子宫颈长度均超过3 cm，术后12个月随访时子宫颈长度分别达原始长度的96.5%、97.5%。 结论： 子宫颈HSIL、AIS首次LEEP术后内切缘阳性患者，后续行二次联合手术为一种不错的选择。通过该手术，可完全切除病灶，且在其后的随访中，阴道镜检查未发现病变残留及复发，并增加HR-HPV持续转阴率。.