Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China

Abstract

Background There are limited data comparing the oncologic and fertility outcomes of patients with early-stage cervical cancer (CC) treated by minimally invasive radical trachelectomy (MIRT) or abdominal radical trachelectomy (ART). The purpose of this multicenter study is to compare the oncologic and fertility outcomes of patients treated by MIRT or ART in a randomized controlled manner in China. Methods This is a noninferiority, randomized controlled trial performed at 28 Chinese centers; the study is designed to compare the oncologic and fertility outcomes of patients treated by MIRT (robot-assisted or laparoscopic RT) or ART. Patients will be recruited if they have been diagnosed with stage IA1 (with lymphovascular space invasion), IA2, or IB1 CC (with a maximum tumor diameter ≤ 2 cm) in the FIGO 2009 staging system and histological subtypes of squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma and if they are also aged 18 to 40 years. These candidates will be randomly assigned to undergo MIRT or ART. The primary endpoint will be disease-free survival. Secondary endpoints will consist of overall and disease-free survival rates, fertility outcomes, and quality of life. A total of 414 patients are needed to accomplish the study goal, with 90.1% power at a 0.050 significance level to detect an equivalence hazard ratio of 0.75 in the ART group, considering 20% loss to follow-up. Discussion The results of the trial should provide robust evidence to surgeons regarding options for the surgical approach in patients with early-stage CC who have a strong willingness to preserve fertility. Trial registration ClinicalTrials.gov NCT03739944. Registered on November 14, 2018

Feasibility and Outcomes of “No-Look No-Touch” Laparoscopic Radical Trachelectomy for Early-Stage Cervical Cancer

“…Recently, a randomized controlled trial of abdominal versus MIS radical trachelectomy incorporated a specific procedure to prevent intraoperative cancer cell spillage into the surgical field. The result of this RCT will disclose the real merit of the no-look no-touch technique [ 24 ].…”

Prince and princesses: The current status of robotic surgery in surgical oncology

“…Currently, no RCTs exist for robotic pancreaticoduodenectomy. However, three trials, DIPLOMA‐2, PORTAL, and EUROPA, have recently finished accruing patients, and data comparing RPD to open approach should be available in 2024 62–64 . While RCTs investigating RPD remain ongoing, data from large, retrospective cohort studies have supported the use of the robot for pancreaticoduodenectomy.…”

Laparoscopic and Robotic Surgery for Endometrial and Cervical Cancer

“…There is currently an international multicentre retrospective study being conducted to assess the oncological safety between open versus minimally invasive (laparoscopic or robotic) radical trachelectomy in women with FIGO stage IA2 or IB1 (2 cm) cervical cancer [112]. Additionally, there is a Chinese multicentre randomised controlled trial comparing the oncological and fertility outcomes of patients with ECC (IA1, with lymphovascular space invasion, IA2 or IB1, with a maximum tumour diameter of 2 cm; FIGO) treated by MIS or open surgery [113].…”