Colorectal CancerNCT05961423
Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer
A study testing Robotic surgery in people with Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Robotic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jun 2020to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Jin-Tung LIANG
Taipei, 886
Jin-Tung LIANG, PhD, 886-9-72651432, jintung@ntu.edu.tw
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Robotic surgery
- Keywords
- Lymphadenectomy, Colorectal cancer, D3-D4
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgeryProcedure or surgery
The patient group undergoing robotic surgery for the treatment of locally advanced colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery | No intervention | The patients will undergoing laparoscopic surgery for the treatment of locally advanced colorectal cancer |
| Robotic group | Active comparator | The patients will undergoing robotic surgery for the treatment of locally advanced colorectal cancer Receives: Procedure: Robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to recurrence of cancer after curative resection
The duration between the time of curative resection and the time to cancer recurrence
Measured: Up to 3 years
Secondary outcomes (5)
the number of dissected lymph nodes
The total numbers of lymph node harvested during the operation
Measured: An average of 7 days
The distribution of dissected lymph nodes
The total numbers of lymph node harvested in different lymph node area during the operation
Measured: An average of 7 days
Functional recovery
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).
Measured: Up to 6 months
The overall costs of both minimally invasive surgical approaches
The total medical costs including medication fee and equipment fee are recorded.
Measured: Through patients' discharge from hospital, an average of 7 days
Assessment of disability
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start19 Jun 2020
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: laparoscopic surgery Interventional group: robotic surgery
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
- Investigators
- Jin-Tung LIANG, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961423
- Sponsor's protocol ID
- 202002011RINB
- Status last verified
- Apr 2023
- First submitted
- 9 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05961423
- Acronym / sponsor ID
- 202002011RINB
- Conditions
- Colorectal Cancer
- Keywords
- Lymphadenectomy, Colorectal cancer, D3-D4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group: laparoscopic surgery Interventional group: robotic surgery
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery | No intervention | –The patients will undergoing laparoscopic surgery for the treatment of locally advanced colorectal cancer |
| Robotic group | Active comparator | Procedure: Robotic surgeryThe patients will undergoing robotic surgery for the treatment of locally advanced colorectal cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic surgeryThe patient group undergoing robotic surgery for the treatment of locally advanced colorectal cancer | Procedure or surgery | Robotic group |
Primary outcome
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
5 secondary outcomes
the number of dissected lymph nodes
Time frame: An average of 7 days
The distribution of dissected lymph nodes
Time frame: An average of 7 days
Functional recovery
Time frame: Up to 6 months
The overall costs of both minimally invasive surgical approaches
Time frame: Through patients' discharge from hospital, an average of 7 days
Assessment of disability
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tung LIANG, PhD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic surgery in people with Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Tung LIANG, PhD (886-9-72651432, jintung@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to recurrence of cancer after curative resection (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.