(1)子宮頸癌に対する妊孕性温存手術としての腹式広汎および単純子宮頸部摘出術について : 適格条件,術式の有用性,妊娠分娩例の検討(<特集>第62回学術講演会シンポジウム1 婦人科癌における妊孕性温存治療(手術および薬物療法))

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In 1986, Dargent performed the first vaginal radical trachelectomy associated with laparoscopic pelvic lymphadenectomy and reported that this procedure is also appropriate from the perspective of long-term prognosis. Thereafter Smith et al. began performing abdominal radial trachelectomy (ART) to address the problem of incomplete resection of the cardinal ligament in the vaginal approach. We began performing ART in June 2005 after IRB approval. We apply parametrial resection level in abdominal radical hysterectomy performed in Japan to our ART. We thought that our ART should also be performed for cervical cancer larger than those for which patients undergo vaginal radical trachelectomy overseas. Therefore, we established our independent eligibility criteria. The subjects of the present study were cases until March 2010 and the following were examined: (1) validity of the eligibility criteria, (2) specific surgical complications, and (3) progress of cases of pregnancy and childbirth. The preoperative eligibility criteria included general requirements such as women with a strong desire to have children but without infertility that is difficult to treat, without cancer of histologic type with poor prognosis, without suspicion of extrauterine spread on imaging, and without serious complications. Our independent criteria of ART consisted of the following. Criterion (a) was women who had stage I b1 or less advanced squamous cell cancer (including very early stage II a) with a transverse diameter of less than 3cm and with a cancer-free space between the tumor and internal os of at least 1cm. Criterion (b) was women who had stage. I b1 or less advanced adenocarcinoma with a transverse diameter of less than 2cm and with mainly exophytic growth. If the transverse and longitudinal diameters were almost the upper limits of the eligibility criteria, neoadjuvant chemotherapy (NAC) was performed after thorough discussion with the patient. Our independent criteria of abdominal simple trachelectomy (AST) consisted of the following. These early cancer cases underwent AST which does not require resection of cardinal ligaments. Criterion (c) was women who had stage I a1 or less advanced squamous cell carcinoma and who were at high risk for positive resection margins that could not be followed up after conization alone, or who had recurrence during follow-ups after conization. Criterion (d) was women who were at an earlier stage than stage I b1 adenocarcinoma with invasion within 3mm (FIGO stage I a1). The intraoperative eligibility criteria were women who were without lymph node metastasis by frozen-section evaluation, and without a lesion at the resection margin in the extirpated cervical area and in the cervical canal 5mm from the resection margin. We attempted ART in 52 patients (among whom 8 were NAC cases) in the period ending in March 2010. There were 6 patients who were excluded due to intraoperative histological examination (among whom 5 had lymph node metastases and one had a positive resection margin in the cervix). ART was performed in the remaining 46 patients. Postoperative adjuvant therapy included systemic chemotherapy and whole pelvic external irradiation. Systemic chemotherapy was performed in 6 patients with vascular permeation and deep stromal invasion. Whole pelvic external irradiation was performed in 1 patient with a sentinel node micrometastasis which was not identified intraoperatively but found postoperatively. Ten patients underwent AST. None had a positive sentinel node or a positive resection margin in the cervix, and AST was completed successfully in all 10 cases. No AST case required postoperative adjuvant therapy. The mean postoperative follow-up period was 24 months (range: 1〜58 months), and presently there have not been any cases of relapse. This procedure caused 3 specific postoperative complications: infection mainly in the uterovaginal anastomotic site, postoperative cervical stenosis, and uterine amenorrhea. There were 13 cases (23%) with infection at the anastomotic site, but all recovered within a few days of readministration of antibiotics. Recently, there has been a decreasing trend in infection at the anastomotic site because of monofilament threads used in uterovaginal sutures, postoperative use of broad spectrum prophylactic antibiotics, and daily postoperative vaginal lavage and antibiotic vaginal tablet. There were 18 cases (32%) that developed postoperative cervical stenosis. The cervical canal was dilated under anesthesia to avoid future obstruction. Recently, the frequency of dilation has decreased due to sutures placed more loosely in cervical cerclage and placement of FD-1^[○!R]. There were 4 cases (7%) with uterine amenorrhea. Initially, the Kuestner uterine forceps were used intraoperatively for grasping the uterus, but sufficient pressure developed to cause "crush" marks on the uterine body. Since November 2009, we have been using 3 absorbable threads passed through the bilateral round ligaments and the uterine fundus for grasping and traction. Suture traction has been used on 7 cases to date, and uterine amenorrhea has not been observed. There has been one patient who became pregnant after ART and one patient after AST. The former patient had a missed abortion at 8 weeks of pregnancy. The latter patient had a Cesarean section at 28 weeks and 0 days of pregnancy because a varix near the uterovaginal anastomotic site became enlarged and began to hemorrhage. This patient gave birth to a girl weighing 1,038g, and the varix rapidly disappeared with uterine contraction. We expanded the indications for trachelectomy and established new eligibility criteria. We have performed trachelectomy in a total of 56 cases to date, and it was completed safely in all. Although specific postoperative complications have occurred, there have not been any cases of relapse. We think valid eligibility criteria have been established. A randomized study cannot be conducted for trachelectomy, and therefore, it is difficult to establish a high level of evidence. Trachelectomy is a clinically investigative therapy whose evidence has not been established at this time. To establish high-quality evidence, it will be necessary to consolidate, accumulate, and standardize measures such as for postoperative complications, surgical techniques, and management methods.
2010-10-01

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