Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION) (SOLUTION)

June 23, 2023 updated by: Hee Seung Kim, Seoul National University Hospital

Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study

The SOLUTION trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cervical cancer is the 4th most common gynecologic cancer and treatment in early stages consists of surgery, chemotherapy, or radiation therapy. Surgical methods are simple or radical hysterectomy and pelvic and para-aortic lymph node dissection either done in an open manner or minimally invasive surgery (robotic or laparoscopic). However, a phase III cinical trial in 2018 comparing the safety and efficacy between minimally invasive surgery and open surgery in performing radical hysterectomy, 'Laparoscopic Approach to Cervical Cancer' (LACC), showed that open surgery is safer than minimally invasive surgery. Possible causes of such results are as follows:

  1. Carbon dioxide is supplied during laparoscopic operations to maintain capnoperitoneum, which can cause the implantation and proliferation of tumor cells exposed to the peritoneal cavity.
  2. Insertions of uterine manipulators into the endometrial cavity is commonly done, which can cause tumor cells to travel to both salpinges.
  3. Tumor cells can be exposed to the peritoneal cavity when the cervix is exposed during intracorporeal colpotomy.
  4. Tumor cells exposed to the peritoneal cavity can travel upwards when the patient's position is maintained in the Trendelenburg position during minimally invasive operations, leading to distant metastasis.

Based on the above-mentioned hypothesis, the following methods could be applied to minimize the exposure of tumor cells to the peritoneal cavity.

  1. The application of a vaginal tube instead of a uterine manipulator to prevent tumor cells from traveling to the salpinges.
  2. The ligation of both salpinges prior to insertion of a vaginal tube to block the travel of tumor cells.
  3. The performance of extracorporeal colpotomy instead to prevent the exposure of tumor cells inside the peritoneal cavity.

Although it would be favorable to perform all the forementioned methods, extracorporeal colpotomy is difficult to perform especially in menopausal patients with atrophic vaginitis or patients with no sexual experience. Thus, an alternative method is to use an endoscopic stapler which can simultaneously cut and suture the cervix into a vaginal stump, which can prevent tumor cells from being exposed to the peritoneal cavity.

In conclusion, this clinical trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Hee Seung Kim, MD
        • Sub-Investigator:
          • Maria Lee, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center, Sungkyunkwan University School of Medicine
        • Contact:
          • Yoo Young Lee, MD
        • Sub-Investigator:
          • Chel Hun Choi, MD
      • Suwon, Korea, Republic of
        • Recruiting
        • Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
        • Contact:
          • Tae Wook Kong, MD
        • Sub-Investigator:
          • Suk Joon Chang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Females, aged 20 years or older
  • Histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix

  • Patients with FIGO stage IB1 (FIGO staging 2009)

    : stromal invasion>5 mm or 7 mm <lesion size ≤4 cm

  • Patients undergoing either type B or C hysterectomy (Querleu-Morrow classification)

  • Patients with normal bone marrow, renal and hepatic function

    • WBC > 3.0x10^9 cells/L
    • Platelets > 100x10^9 cells/L
    • Serum creatinine ≤1.5 mg/dL
    • Serum total bilirubin <1.5 x normal range and AST/SGOT or ALT/SGPT <3 x normal range
  • ECOG performance status 0 or 1
  • Synchronous cancer with no evidence of recurrence during the past 5 years
  • Informed consent of patient

Exclusion Criteria:

  • Any histological type other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
  • Tumor size greater than 4 cm

  • Patients with FIGO less than stage IA2 or greater than IB2 (FIGO staging 2009)

    • stromal invasion ≤5 mm and lesion size ≤7 mm (less than IA2)
    • or lesion size> 4 cm (greater than IB2)
  • Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes greater than 2 cm, or histologically positive lymph nodes
  • Patients in pregnancy
  • Patients with a history of pelvic or abdominal radiotherapy
  • Patients with contraindication of surgery (serious concomitant systemic disorders incompatible with the study to be decided at the discretion of the investigator)

  • Patients who agree to intra-operative lymphatic mapping (IOLM) must not have:

    • Known allergies to triphenylmethane compounds
    • History of retroperitoneal surgery.
    • History of pelvic irradiation.
    • Cold knife or LEEP cone biopsy within 4 weeks of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOLUTION group
Patients enrolled in this clinical trial will undergo radical hysterectomy through minimally invasive surgery using an endoscopic stapler which both cuts and simultaneously sutures the open vaginal stump.
Procedure: Minimally invasive surgery using endoscopic stapler
Radical hysterectomy by minimally invasive surgery (laparoscopic or robotic) will be done with the help of an endoscopic stapler in cutting and suturing the uterine cervix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4.5 year disease-free survival [DFS] rate
Time Frame: Examined at post-operative 4.5 years
Probability of no recurrence from the day of surgery until post-operative 4.5 years
Examined at post-operative 4.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4.5 year overall survival [OS] rate
Time Frame: Examined at post-operative 4.5 years
Rate of survival from the day of surgery until post-operative 4.5 years
Examined at post-operative 4.5 years
Pattern of recurrence sites
Time Frame: Examined every 3 months during post-operative 1 year, every 2 months during post-operative 2 years, and every 6 months during post-operative 4.5 years
Anatomical site of recurrent cancer according to imaging modalities
Examined every 3 months during post-operative 1 year, every 2 months during post-operative 2 years, and every 6 months during post-operative 4.5 years
Morbidity
Time Frame: Examined during operation and post-operative 4 and 6 weeks.
Intra-operative and post-operative complications occurring in less than post-operative 4 weeks and between post-operative 4 and 6 weeks. Other morbidity include estimated blood loss during surgery, post-operative pain and amount of analgesic consumption
Examined during operation and post-operative 4 and 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Johnson & Johnson

Investigators

  • Principal Investigator: Hee Seung Kim, M.D. Ph.D., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 19, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB No. 2002-101-1103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan whether to share IPD will be decided once enrollment of the clinical trial starts.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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