This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05961423
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : August 1, 2023
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Clinical Trial Center, National Taiwan University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Approximately one third of patients with colorectal cancer are diagnosed as locally advanced stage with metastasis to N3 - N4 lymph nodes requiring a D3 - D4 lymphadenectomy. Our previous study has indicated that, by laparoscopic approach, the extended abdomino-iliac lymphadenectomy, the so-called D3-D4 lymph node dissection, could be performed with quick convalescence and similar oncologic efficacy for the treatment of advanced recto-sigmoid cancer with metastatic lesions over N3-N4 lymph nodes, as compared with traditional open surgery. In the present study, the investigators will further compare the oncologic and functional outcomes of robotic versus laparoscopic approach in performing such challenging surgical procedures for patients with advanced colorectal cancer requiring a D3-D4 lymphadenectomy through a randomized prospective clinical trial.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Robotic surgery Not Applicable

Detailed Description:

Approximately one third of patients with colorectal cancer are diagnosed as locally advanced stage with metastasis to N3 - N4 lymph nodes requiring a D3 - D4 lymphadenectomy. Our previous study has indicated that, by laparoscopic approach, the extended abdomino-iliac lymphadenectomy, the so-called D3-D4 lymph node dissection, could be performed with quick convalescence and similar oncologic efficacy for the treatment of advanced recto-sigmoid cancer with metastatic lesions over N3-N4 lymph nodes, as compared with traditional open surgery. In the present study, the investigators will further compare the oncologic and functional outcomes of robotic versus laparoscopic approach in performing such challenging surgical procedures for patients with advanced colorectal cancer requiring a D3-D4 lymphadenectomy through a randomized prospective clinical trial.

In the upcoming three years (2020/4/1-2023/3/31),consecutive recto-sigmoid cancer patients with metastasis to para- aortic lymph node will be screened and randomized to patient groups undergoing either robotic or laparoscopic D3-D4 lymph node dissection. The extent of D4 lymph node dissection includes extirpation of the extra-mesenteric lymphatic basin along bilateral common iliac arteries and veins, inferior vena cava, and abdominal aorta upward to the level just below the duodenal third portion and left renal vein, besides the traditional mesenteric dissection of paracolic (N1) lymph nodes, intermediate (N2) mesenteric lymph nodes, and lymph nodes around the root of inferior mesenteric artery (N3). The harvested lymph nodes were mapped and managed according to the Japanese guidelines. The metrics of surgical outcomes included: the number of harvested lymph nodes; time to recurrence of cancer after surgery; the length of operation time; blood loss; intra-operative and post-operative complications; and wound size. Functional recovery was evaluated by length of post-operative flatus passage, the restoration of urinary function, hospitalization, and degree of post-operative pain. A subjective-response standardized questionnaire was given to patients to assess disability, which included the number of days until return to partial activity, full activity, and work.

Since the current randomized prospective study in this field is still lack of, the investigators believe that this study will be of academic importance. And, clinically, the presented study can to help set up the standard operation procedures for such patient, and provide the level one evidence for National Health Insurance Administration in evaluating the reimbursement of HTA (high technology assessment) procedures.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Control group: laparoscopic surgery Interventional group: robotic surgery
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Robotic Versus Laparoscopic D3-D4 Lymphadenectomy for Patients With Advanced Colorectal Cancer… A Randomized Prospective Clinical Trial for the Comparison of Oncologic and Functional Outcomes
Actual Study Start Date : June 19, 2020
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2024
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Laparoscopic surgery
The patients will undergoing laparoscopic surgery for the treatment of locally advanced colorectal cancer
Active Comparator: Robotic group
The patients will undergoing robotic surgery for the treatment of locally advanced colorectal cancer
 Procedure: Robotic surgery
The patient group undergoing robotic surgery for the treatment of locally advanced colorectal cancer


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The time to recurrence of cancer after curative resection [ Time Frame: Up to 3 years ]
    The duration between the time of curative resection and the time to cancer recurrence


Secondary Outcome Measures :
  1. the number of dissected lymph nodes [ Time Frame: An average of 7 days ]
    The total numbers of lymph node harvested during the operation

  2. The distribution of dissected lymph nodes [ Time Frame: An average of 7 days ]
    The total numbers of lymph node harvested in different lymph node area during the operation

  3. Functional recovery [ Time Frame: Up to 6 months ]
    Functional questionnaire regarding fecal continence and bowel function will be completed by an assistant not aware of the randomization status of the patient right after completion of the manometric studies. Continence was recorded as Grade 1 (perfect continence), Grade 2 (incontinence of flatus), Grade 3 (occasional minor soiling), Grade 4 (frequent major soiling), and Grade 5 (total incontinence).

  4. The overall costs of both minimally invasive surgical approaches [ Time Frame: Through patients' discharge from hospital, an average of 7 days ]
    The total medical costs including medication fee and equipment fee are recorded.

  5. Assessment of disability [ Time Frame: 12 months ]
    The time for the patients after the operation to resume partial activity, full activity, and return to work will be recorded to evaluate the disability.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically proved adenocarcinoma located at upper rectum (above pelvic peritoneal reflection), recto-sigmoid junction, or distal sigmoid colon (generally 10 to 25 cm above anal verge). Only recto-sigmoid cancers above the peritoneal reflection were investigated because the lymphatic drainage of upper rectum and distal sigmoid colon was along the inferior mesenteric artery to the para-aortic area, and therefore the extent of surgical resection and lymph node mapping were standardized.
  • Clinically TNM stage III cancers.
  • Curative robotic or laparoscopic surgery.
  • American Society of Anesthesiology (ASA) class I to III patients.
  • Age between 50 and 75 years. This was because patients >50 years old are generally deemed to be over the reproductive age, and the D3 dissection was considered too aggressive for patients older than 75 years.
  • Patients who are willing to receive minimally invasive surgical procedures to treat their rectosigmoid cancer.

Exclusion Criteria:

  • Tumors located at other anatomic positions;
  • Emergency or palliative surgery;
  • Evidence of disseminated disease or adjacent organ invasion;
  • Primary tumor mass ≥8 cm in diameter;
  • Morbidly obese patients (body mass index ≥40 kg/m2);
  • Previous major surgery of lower abdomen.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05961423


Contacts
Layout table for location contacts
Contact: Jin-Tung LIANG, PhD 886-9-72651432 jintung@ntu.edu.tw

Locations
Layout table for location information
Taiwan
Jin-Tung LIANG Recruiting
Taipei, Taiwan, 886
Contact: Jin-Tung LIANG, PhD    886-9-72651432    jintung@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Study Chair: Jin-Tung LIANG, PhD National Taiwan University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: National Taiwan University Clinical Trial Center, Division of colorectal surgery, department of surgery, National Taiwan University Hospital, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT05961423    
Other Study ID Numbers: 202002011RINB
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: August 1, 2023
Last Verified: April 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Clinical Trial Center, National Taiwan University Hospital:
Lymphadenectomy
Colorectal cancer
D3-D4
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases