Clinical trial · Interventional
Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer
NCT02368574CI-TRIAL-00016911unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Based on the value-based medicine, a randomized clinical trial was conducted to compare the role of class II and class III hysterectomy in patients with low risk early staged cervical cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Class II hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Class III hysterectomy Arm
- description
- Class III hysterectomy (radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. Perivesical space and perirectal space should be opened, and the ureteral tunnel is completely separated and pushed down to the junction of ureter and urinary bladder. The uterine arteries are ligated at the level of internal iliac artery, and all the supporting ligaments and connective tissues around the uterus should be separated and abscised. The uterosacral ligament is removed near the sacrum, the cardinal ligament is removed near the pelvic wall, and the vagina is removed after the excision of peivaginal connective tissues, about 3-4cm from the cervical lesion. The pelvic lymph nodes are usually dissected at the same time.
- type
- EXPERIMENTAL
- label
- Class II hysterectomy Arm
- description
- Class II hysterectomy (modified radical hysterectomy): This procedure may be performed through laparotomy or laparoscope. The scope of surgery is more extensive than Class I epifascial panhysterectomy, demanding the excision of more parametrium but reservation of the blood supply for distal ureter and urinary bladder. The ureter is separated from the ureteral tunnel, the vesicouterine ligament should be intact, and 1/2 uterosacral ligament and 1cm vagina are excised. The pelvic lymph nodes are usually dissected at the same time.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage IA2 and small IB1 \<2 cm 2. Less than 50% stromal invasion based on MRI OR 10mm stromal invasion based on the pathology measurement of the LEEP/cone specimen 3. Squamous OR adenocarcinoma OR adenosquamous 4. Grade 1, 2 and 3 5. Lymph-vascular space invasion (LVSI): presence or absence 6. Diagnosis confirmed by LEEP/cone/cervical biopsy 7. Pelvic MRI in patients with involved cone/LEEP margins and those who had cervical biopsy only 8. Abdomino-pelvic CT scan in patients with negative LEEP-cone margins 9. No contraindications to surgery 10. No desire to preserve fertility 11. Informed consent Exclusion Criteria: 1. High-risk histology types (clear cell, small cell etc) 2. Evidence of lymph node metastasis on preoperative imaging 3. Stage 1A1 4. Neo-adjuvant chemotherapy 5. Pregnancy 6. Desire to preserve fertility
References
Publications (1)
- DERIVEDSun H, Cao D, Shen K, Yang J, Xiang Y, Feng F, Wu L, Zhang Z, Ling B, Song L. Piver Type II vs. Type III Hysterectomy in the Treatment of Early-Stage Cervical Cancer: Midterm Follow-up Results of a Randomized Controlled Trial. Front Oncol. 2018 Nov 28;8:568. doi: 10.3389/fonc.2018.00568. eCollection 2018. PMID 30555800