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General Obstetrics and Gynecology:
Radical trachelectomy and pelvic lymphadenectomy with uterine preservation in the treatment of cervical cancer

John B. Schlaerth, MD,a Nicola M. Spirtos, MD,b and Alan C. Schlaerth,MD,a
aPasadena and bPalo Alto, Calif

Objective: The purpose of this study was to determine whether medical trechelectomy, combined with pelvic lymphadenectomy, can be a feasible method for the treatment of early-state cervical carcinoma in women who want to preserve their fertility.

Study Design: From January 1, 1996, through December 31, 1999, 12 women with stage 1 carcinoma of the cervix were scheduled to undergo radical trachelectomy and pelvic lymphadenectomy of the intact uterus as treatment. The procedure was abandoned in 2 women because of endometrial extension of the cancer. Surgical margins were clear in all other women. No lymph node metastases were encountered. The proximal cervical remnant was reinforced in 10 women.

Results: Hospitalization ranged from 2 to 8 days (mean 3.2 days). Estimated blood loss average 203 mL (range 50-600 mL). Complications included 2 introperative cystotomies and 1 pelvic hematoma. Four pregnancies have occured, with 2 third-trimester deliveries and 2 preterm losses at 24 and 26 weeks of gestation, respectively. The follow-up period has ranged from 26 to 84 months (mean, 47.6 months).

Conclusion: Radical trachelectomy, combined with pelvic lymphadenectomy, can be a feasible method of treatment for early-stage cervicial carcinoma in women who want to preserve their fertility.

Keywords: Radical trachelectomy, cervical cancer.


The recent changes in surgical treatment for gynocological cancers have emphasized minimizing invasiveness, lessing postoperative disability, and preserving function. With these concepts, it has been demonstrated and accepted that stage IA1 cervical cancers can be treated by cerviceal conization, thus preserving fertility in young women. However, with traditional approaches to stage IA2, IB, and IIA cervical cancers, (ie. radical hysterectomy and pelvic lymphadenectomy or chemoradiation), fertility is lost. It has been recently suggested that these early stage carcinomas of the cervix can be treated appropriataely in young women, with the preservation of fertility. D'Argent et al 1 in 1994 described an operation called, the the English language medical literature, radical vaginal trachelectomy. Their initial experience has been expanded and repeated by others. 2-5 Despite the fact that the total number of patients who were treated remains small and long-term results are not available, there seems to be short-term control of the disease that is comparable to traditional sugrical procedures. Further, pregnancies have occurred, and children have been born to women in these reports.

In 1995, we began offering this concept and its database to patients with early stage cervical cancer. The risk of lymph node metastases in these cancer stages (stage IA2, IB, and IIA) is significant, and the traditional therapies are directed not only to the primary site, but also to the adjacent lymph nodes. Simultaneous with our developing of, and experience with, radical trachelectomy, we had developed an extensive experience with laparoscopic pelvic lymphadenectomy and aortic lymph node sampling, both on our own and as a participant in National Cancer Institute study protocols of the methods through the Gynecologic Oncology Group.

Materials and Methods

From January 1995 to December 1999, 10 women underwent radical trachelectomy of the intact uterus and pelvic lymphadenectomy as treatment for their early-stage carcinoma of the cervix. The patients have all completed at least 2 years of follow-up. Two different approaches were used to perform the radical trachelectomy: vaginal and laparoscopically assisted vaginal. The radical vaginal trachelectomy technique is the one used in previous reports. The vaginotomy, paravaginal and paracervical dissection, purchases of the uterosacral and cardinal liganenos, litigation of teh decending branch of the uterine atery, ureterolysis, and transection of the distal cervix follow the primary steps of a radical vainal hysterectomy. (Figs 1 and 2).

The laparoscopically assisted radical vaginal trachelectomy, which was investigated here, was in a way, a continuation of the laparoscopic pelvic lynphadenectomy. The ureters were exposed as they entered the tunnel through the cardinal ligament: the uterine vessels were skeletonized, and the bladder had begun to be dissected inferiorly. At times, the uterine vessels were divided at their origin, and the urecerolysis completed. The cardinal and uterosacral ligaments were then divided, and anterior and posterior colpotomy could be performed laparoscopically. The completion of the colpotomy, the securing of the proximal paravaginal tissues, and the transection of the cervix were completed vaginally.

The pelvic lymphadenectomy that was performed in this series included a deliberate dissection of the parametirial lymph nodes because they are the first order lymph nodes for drainage from the cervix and they are always removed with the radical hysterectomey surgical specimen, as opposed to the pelvic lymph node surgical specimen. Their removal is deemed a vital part of radical trachelectomy and pelvic lymphadenectomy for cervical cancer.

Results

Two patients were found introperatively to have extention of the cancer to the proximal cervix/uterus fundus. Both women immediately underwent radical hysterectomy on discovery of this extention.

All 10 women were in their childbearing years: the average age was 30.0 (range, 23-44 years). All the women were nulliparous. Six of the women underwent a radical vaginal trachelectomy and 4 of the women underweny a laparoscopically assisted vaginal trachelectomy.

The histologic condition of the cancers were adenocarcinomas in 5 women, squamous cell in 4 women, and adenosquamous in 1 woman. Eight cancers were stage 1A2 (7 cancers were diagnosed on cone biopsy), and 2 cancers were stage 1B. Details of the cervical lesions are shown in Table I. In this series, the time that was required for the radical trachelectomy and pelvic lymphadenectomy were not separated. There was a distince impression that long operating times, when they occurred, were due to lapharoscopic component.

Blood loss ranged from 50 to 600 mL, with a mean loss of 203 mL. No patients received intraoperative or postoperative transfulsion. The mean lymph node count was 23 (range, 9-10). No metastic lylmph nodes were encountered. One lesion exhibited vascular space involvement.

Ureteral ascents were, at times, placed before the radical trachelectomy to aid in the identification of the uretas. Two patients sustained cystocomies during transvaginal dissection. These were repaired without incident. After operation, all patinets were maintained on Foley catheter drainage, which continued after discharge. The average hospital stay was 3.2 days (range, 2-8 days). Diagnosis, drainage, and recovery from an infected paravaginal hematoma were responsible for the longest hospitalization.

One patient with an adenocarcinoma had a follow-up Papanicolaou smear that showed atypical glandular cells of undetermined significance (AGUS). Endocervical curetage was negative, and further follow-up examinations over the ensuing 18 months have been normal. All 10 patinets have completed at least 2 years of follow-up examiniations: 2 patients have completed 5 years of follow-up examinations.

Fertilility Factors. All 10 patients have had their fertility spared. All the patients had cervical cerclages at the time of trachelectomy. Mersilene 5 mm tape (Mersillen; Ethicon, Inc. Somerville, NJ) was used in all but 2 cases (No. 1; Ethicbond; No. 1 prolene; Ethicon Inc., Somerville, NJ). The cerclage in 1 patient was expelled 9 months after the operation and not replaced. Four patients have achieved pregnancy; two losses at 24 and 26 weeks of gestation (hysterotomies), a viable term birth by cesarean section at 32 weeks of gestation, and a viable term birth by cesarean section at 38 weeks of gestation. After radical trachelectomy, a Foley catheter was inserted through the endocervix, and the balloon was inflated to serve as traction device to aid in the placement of the cerclage. Typically, it remained in place for a few days to avoid pyomecra or hematometra.

Two patients had amenorrhea during the follow-up period. Cervical stenosis was apparent, and hematometras were eventually released in both . For one of these women, laparoscopic assistance was necessary to define the upper vaginal/cervical anatomy so that drainage could proceed safely. Menses have resumed in both women. Both cervices seemed particularly fibrosic and small. Both women had ligacion of uterine arteries at their origin at the hypogastric arteries during laparoscopy before the radical trachelectomy. Treatment and outcomes are summarized in Table II.

Intraoperative and perioperative outcomes. Transurethral Foley catheter drainage was standard. Attempts to discontinue the catheter at discharge were unsuccessful, and between 2 and 3 weeks of significant urinary retention were typical.

In all cases, gross examination of the cancer at the point of transection of the endocervical canal took place during the operation. An adequate gross margin was apparent in all but 2 instances, in which the procedure continued as a radical hysterectomy. In six cases, rapid frozen section of the endocervical margins were performed. All were clear. In 5 cases, curettage of the remaining endocervix was performed. None of the cases showed neoplasia on permanent section.

Late outcomes. Once epithelializaton of the cervix had occurred, a tapering proximal vagina that led to the endocervical canal was usually seen. Palpation of the cerical remnant and isthmus on rectal examination gave the only evidence of a cervix. Follow-up endocervical curetages usually could be performed. Cytobrush sampling was applicable in all cases. Granulation tissue was treated by silver nitrate cautery. In 1 instance, erosion and ultimate explulsion of the cerclage stitch were responsible for granulation tissue. On final pathologic review, 1 squamous cell carcinoma was within 1 mm of the cervical margin. Radical hysterectomy was advised but refused by the patient. She has remained disease free for 74 months.

All patients have completed at least 2 years of follow-up examinations. The intervals after radical trachelectomy and pelvic lymphadenectomy raned from 28 to 34 months (mean, 47.6 months).

Comment

Roy and Plante 4 and D'Arent et al7 have suggested criteria for performing a radical trachelectomy: (1) a desire to preserve fertility; (2) no clinical evidence of impared fertility; (3) stage IA2 or IB; (4) lesion size <2 cm; (5) absence of adenocarcinoma; (6) absence of capillary space involvement; (7) limited endocervical involvement on colposcopic examination; and (8) no evidence of pelvic lymph node metasis. These guidelines all address imporant issues, but exactly when they become known during treament presents problems.

Because of a desire for future fertility, stage and lesion size are purely preoperative determinants; some of these criteria are largely intraoperative considerations (infertility caused by adnexal disease, endocervical involvment, lymph node metastasis. The determination that an adenocarcenomatous element or significant vascular space involvement is absent usually requires complete analysis of the radical trachelectomy specimen. An intricate and prolonged stepwide clinical evaluation is required before the decision is made that the treatment of the cancer and maintenance of fertilitiy can be achieved.

The patients' retention of fertility was an overriding concern that was stated during initial examination. The decision to proceed with a radical trachelectomy was a patient-driven process. No patient was solicited for this procedure. During the informed consent process, the database in the the literature was reviewed in detail. The lack of extensive experience with disease control, fertility, and long-term follow-up were mentioned. The risks and complications that were known versus the risks of the standard surgical and radiation therapies were presented. This was presented as an exceptional therapy, which applied modifications of standard procedures (ie. radical trachelectomy and pelvic lymphadenectomy) on women with an intact uterus. Last, the possibility of compromised fertility from the operation was noted.

No patient gave a history that suggested problems with fertility. Physical examination and laparoscopy disclosed no factors that would impede fertility. We did not suggest consultation with a reproductive endocrinologist before the operation. Laparoscopic pelvic lymphadenectomy was performed before the radical trachelectomy. The possibility of finding extensive tubal disease, endometriosis, or adhesions was discussed. A clear decision about how to proceed, should these finding suggest that advanced reproductive thereapy would be necessary to achieve a pregnancy was solicited. If a fertility problem is suggested before the surgery, the situation should be evaluated as far as reasonable before the decision to proceed is made.

All patients had early state, and most of the patients had relatively small cancers. Eight patients underwent cone biopsies for diagnosis (7 stage 1A, 1stage 1B). There were 8 women with stage 1A2 lesions and 2 women with stage 1B lesions. There is strong evidence that stage 1A2 lesions can be treated adequatedly by conization, trachelectomy or hysterctomy. There is an even stronger basis for the combination of radical excision and lymphadenectomy for stage 1IB lesions. It may perhaps be argued that the threat of a 1A2 lesion is less local and more lymphatic. For stage 1A2 lesions, a cone bipsy with interpretable clear margins may provide as much local control as radical trachelectomy or radical hysterectomy. Plevic lymphadenectomy, however, is still necessary.

The largest lesion in this series was 2 cm in diameter. Radical trachelectomy was abandoned intraoperatively because of endometrial extensions of the cancer in 2 patients. The lesions measured 3.0 and 5.0 cm in diameter. We have viewed size itself as an important but relative contraindication. Increasing size infers extention to th fundus, parametria, and lymph nodes. Exophytic lesions that emanate from the porria of the cervix with narrow bases may be reasonable exception to a size criteria.

Five our our patients had adenocarcinomas, and 1 patient had an adenosquamous lesion. Two pregancies occurred in women with glandular cancers. All 6 women had safe margins, despite the cancers arising from the endocervix. To date, we have not considered adenocarcinoma to be a contraindecation to radical trachelectomy. The issue for radical trachelectomy of the intact uterus that adenocarcinomas present is similar to that of a size criteria (ie. extension to the parameria or to the uterine fundus). Simililarly, so much of the endocervical canal may be involved by disease that salvage of the cervical remnent and fundus is pointless. Again, in the case of an adenocarcinoma that has been excised by cone biopsy with clear margins, no vascular space invasion and negative curettage of the posi-cone endocervical canal has been acceptable to us for radical trachelectomy and pelvis lymphadenectomy in patients who desire fertility retention.

Only 1 patient demonstrated capillary vascular space involvement. This was limited to a few histologic sections and the total amount was small. In view of this, in the absence of metastasis in the lymph nodes, no further therapy was entertained. If the degree of vascular space involvement of the pretreatment biopsy was significant we opted for combined therapy (radiation or chemoradiation) with or without operation. Such patients were not considered for radical trachelectomy and pelvic lymphadenectomy. Although no patients were found to have unexpectedly significant vascular space involvement on the radical trachelectomy specimen, such women woul require the same combined therapies.

We have no appreciable experience to make a statement regarding limited endocervical involvement on colposcopy, because 7 of the 10 patients with cervical cancer who underwent radical trachclectomy and pelvic lymphadenectomy to preserve fertility came to us after a cone biopsy. Only 1 of these patients had residual (microscopic) disease in the radical trachelectomy specimen. The recent post-cone biopsy cervix presents a difficult scenario for colposcopic evaluation of the remaining cervix, regarding residual disease. With clinical lesions, colposcopic evaluation for the degree of endocervical involvement has more promise, although 1 of our 3 patients who was thought to be well clear of the intended margins of excision was found to have a positive margin. Other efforts to determine resectability have been suggested (ie. ultrasound scans, magnetic resonance imaging, and hysteroscopy). The value of these techniques seems to be to exclude women with cervical cancer reliably from radical trachelectomy that is based on too much endocervical involvement by their lesion, rather than to provide strong evidence for resectability. Novertheless, preoperative imaging of the cancer and the cervix could prove worthwhile and, although not performed in our series, deserves consideration. The question of how much endocervical margin suffices as adequate therapy is being debated. The consensus from reports, and our opinion as well, is that a remnant of at least 1 cm of endocervix is necessary for disease control and the maintenance of fertility. The resected margins should be free of invasive and reinvasive disease.

No patient in our series had metastasis to lymph nodes. We agree that metastais to lymph nodes is a contraindication to radical trachelectomy to preserve fertility. Such a finding requires postoperative therapy, which renders such women sterile. We perform the pelvic lymphadenectomy first, examining the lymph nodes by rapid frozen section before preceeding with radical trachelectomy. If metastases are found, the planned radical trachelectomy is abandoned. Similiarly, metastases to the uterine fundus preclude radical trachelectomy. Unexpected involvement of the uterine fundus was encountered twice in our series. The lymph nodes were free of matastasis on rapid frozen section, and the surgery continued as a radical hysterectomy in both. As a general principal, it seems wise to abandon radical trachelectomy during surgery when it is clear that it will not suffice for definitive treatment.

In this series, we have explored expanding the methods for radical trachelectomy beyond what has been described hus far. To date, a radical vaginal trachelectomy has been described and used. There has been little mention of using the laparoscopic route to perform a laparoscopically assisted radical vaginal trachelectomy. The performance of the laparoscopic lymphadenectomy first not only allows for the evaluation of the lymph nodes and the presence of tubal or extratubal factors, but it also allows for maneuvers that can facilitate the radical vaginal trachelectomy, thus becoming a laparoscopically assisted radical vaginal trachelectomy. Some of the techniques used in our development of the laparoscopic radical hysterectomy were applied here. 9 In light of our experience, the development of the paravasical space and mobilizaton of the rectum, bladder, and posterior portion of the pelvic ureter and transection of the uterosacaral ligament can be accomplished laparoscopically.

As far as the sequence of maneuvers to fully address the cervical cancer, it is important that the parametrial lymph nodes be removed. This is the first node group that drains the cervical stroma and is usually removed in toto as part of a radical hysterectomy specimen. Because a substantial portion of the uterus and parametrium remains after radical trachelectomy, it is important to extend pelvic lymphadenectomy to include these lymph nodes.16

The division of the uterine vessels at their origin with the hypogastric vessels, along with the complete division of the paracervical cardinal ligament, uterosacral ligament, and vaginotomy, may be unwise. Although 1 patient has achieved pregnancy, cervical stenosis and atrophy that result in obstructed menstrual flow have occurred in 2 women, and premature pregnancy loss occurred in 1 woman. This combination of procedures perhaps induced a signicant amount of ischemia such that the cervical remnant atrophied significantly. The uterine ateries were no longer divided at their origin. This may indicate that combining the procedures in the laparoscopically assisted radical trachelectomy should be avoided, particularly the division of the uterine vessels at their origin.

Before amputation of the cervix, a Foley catheter ws placed into the uterus, and the balloon was inflated. This served as a traction device and a means for the detrmination of the length of the cervical canal. The goal is to leave approximately 1 cm of proximal cervix below the isthmus. The catheter lso facilitaed the placement of the cerclage and the suturing of the vagina to the remaining cervix. In some patients, the catheter was left in situ for a short time (which may be an unnecessary precaution) to prevent hematometra or pyometra.

Our experience with radical trachelectomy and pelvic lymphadcnectomy suggests that it is an adequate therapy for women with early stage cervical cancer who want to preserve fertility. Although our experience is small, it shows that the preservation of fertility is problematic, as has been reported by other investigators.4,7 We found cervical stenosis as a complication in 2 patients, and the expulsion of the cerclage in another patient. Four pregnancies occurred, and 2 pregnancies were lost in the second trimester. One patient had rupture of fetal membranes with amnionitis, and the other patient had a fetal death. Neither patient demonstrated cervical dilatation. Their obsteric scenario has been inferred in other reports. 6,7 A possible means of avoidance of these losses is surgically closing the cervix after the first trimester. 6 The high rate of pregnancy loss is emerging as the major unresolved issue for ratical trachelectomy.

Currently, our approach to the fertility issue is as follows: pregnancy is avoided (usually by oral contractption) until 1 year of follow-up examination has been completed. An imaging study, usually magnetic resonance imaging, is performed at the 1 year follow-up visit to document the status of the cervical remnant and the cerclage. It is not clear to us whether there is an advantage to clerclage at the time of operation, at the 1 year follow-up visit, or during pregnancy. Once a woman becomes pregnant, early involvement with a perinatologist who is familiar with the second trimester loss rate seems very important if insight into causes, possible prophylactic measures, and possible treamtent meaures are to be gained.

Our report adds to the accumulating data on radical trachelectomy and pelvic lymphadenectomy for early state cancer of the cervix in women with an intact uterus who wish to preserve fertility. Our experience and short term results support radical trachelectomy and pelvic lymphadenectomy as reasonable forms of treatment. Fertility issues remain the largest unanswered problem.


References

  1. D'Argent D, Brun, JL., Roy M., Remi I. Pregancies following radical trachelectomy for invasive surgical cancer ][abstract] Gynecol Oncol 1994;52 :105.
  2. Schneider A, Krause N, Kuhne-Heid R, Noschel H. Preserving fertility in early cervix carcinoma: trachelectomy with laparoscopic lymphadonectomy, [in German.] Zentralbl Gynakol. 1996;118:6-8.
  3. Shepherd JH, Crawford RA, Oram DH. Radical trachelectomy: a way to preserve fertility in the treatment of early cervical cancer. Br J Obstet Gynaecol. 1998;105:912-915.
  4. Roy M, Plante M. Pregnancies after radical vaginal trachelectomy for early-stage cervical cancer. Am J Obstet Gynecol. 1998;179:1491-1496.
  5. D'Argent D. Using radical trachelectomy to preserve fertility in early invasive cervical cancer. Conmporary Obstet Gynocol 2000 :45(5):23-46.
  6. Covens A.L., Shaw P, Is radical trachelectomy a safe alternative to radical hysterectomy for patients with stage IA-B carcinoma of the cervix? Gynecol Oncol 1999;72:443-4.
  7. Dargent D, Martin X, Sacchetoni A, et al. Laparoscopic vaginal radical trachelectomy. Cancer. 2000;88:1877-82.
  8. Roman LD, Felix JC, Muderspatch I, Varkey T, Burnett AF, Quan D. et al.Influence of quantity of lymphevascular space invasion on the risk of nodal matastasis in women with early stage squamous cell carcinoma of the cervix.Gynecol Onco1998:1741763-7.
  9. Spirtos NM, Schlaerth JB, Kimball RE, Leiphart VM, Ballon SC. Laparoscopic radical hysterectomy (type III) with aortic and pelvic lymphadenectomy.Am J Obstet Gynecol. 1996 Jun;174(6):1763-7.
  10. Girardi F, Lichtenegger W, Tamussino K, Haas J. The importance of parametrial lymph nodes in the treatment of cervical cancer. Gynecol Oncol. 1989 Aug;34(2):206-11.

  11. Table I. Disease parameters for patients who underwent radical trachelectomy and pelvic lymphadenectomy.
    Patient Age Histologic
    Condition
    Stage Method
    Diagnosis
    VSI Residual in radical
    trachelectomy specimen
    128Squamous cell carcinoma1A2cone00
    228Adenocarcinoma1A2cone00
    344Squamous cell carcinoma 1A2biopsy0+
    434Adenocarcinoma1B biopsy0+
    535Adenosquamous cell carcinoma1A2cone00
    629Adenocarcinoma1A2cone0+
    728Squamous cell carcinoma1A2cone00
    825Squamous cell carcinoma1A2cone+0
    924Adenocarcinoma1A2cone00
    1034Adenocarcinoma1Bcone00


    Table II. Treatments and sequclae for patients who
    underwent radical trachelectomy and pelvic lymphadenectomy.
    Patient Method of Treatment Disease Outcome Pregnancy Complication
    1Radical vaginal trachelectomyNo evidence of disease00
    2Radical vaginal trachelectomy AGUS0Pelvic hematoma 
    3Radical vaginal trachelectomyNo evidence of disease00
    4Radical vaginal trachelectomyNo evidence of disease+0
    5Radical vaginal trachelectomyNo evidence of disease+0
    6Laparoscopically assisted radical vaginal trachelectomyNo evidence of disease00
    7Laparoscopically assisted radical vaginal trachelectomyNo evidence of disease+0
    8Radical vaginal trachelectomyNo evidence of disease+0
    9Laparoscopically assisted radical vaginal trachelectomyNo evidence of disease0Cervical stenosis
    10Laparoscopically assisted radical vaginal trachelectomyNo evidence of disease0Cervical stenosis