LaparoscopyLRLCCNCT03837782
Outcome of Resection for Colorectal Cancer
A study testing minimally invasive surgery in people with Laparoscopy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
There are limited data from retrospective studies regarding whether short-term and long-term outcomes after laparoscopic or robot-assisted radical colectomy (minimally invasive surgery) are equivalent to those after open abdominal radical colectomy (open surgery) among patients with early and medium-stage colorectal… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Laparoscopy
- What is being tested?
- minimally invasive surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- tumor without distant metastasis; (ii) classified as stage I, II or III by TNM staging system; (iii) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; (iv) a minimum of 12 lymph nodes resected to accurately identify stage; (v) solitary malignant lesion after thorough colonoscopy; (vi) complete resection (R0) with no positive nodes left behind; (vii) histological diagnosis of adenocarcinoma.
Who cannot join
- <18 years or >90 years; (ii) serious concurrent illness; (iii) clinically suspicious distant metastasis detected by positron emission tomography-computed tomography (PET-CT); (iv) familial adenomatous polyposis syndrome (FAP), hereditary non-polyposis colorectal cancer (HNPCC) and other hereditary CRC; (v) postoperative pathological close, indeterminate, or positive margins; (vi) circumferential resection margin < 1mm in rectal cancer; (vii) short anticipated life expectancy due to postoperative comorbidities on account of cardiopulmonary insufficiency.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: Minimally Invasive Versus Abdominal Radical Resection for Colorectal Cancer
There are limited data from retrospective studies regarding whether short-term and long-term outcomes after laparoscopic or robot-assisted radical colectomy (minimally invasive surgery) are equivalent to those after open abdominal radical colectomy (open surgery) among patients with early and medium-stage colorectal cancer.
This trial is a multicenter,prospective, randomized trial evaluating short-term and survival outcomes concerning minimally invasive surgery and open surgery for colorectal cancer.
Read the detailed description
Radical colectomy and proctectomy with regional lymphadenectomy remain the standard recommendation for patients with early and medium-stage colorectal cancer. Current guidelines from the National Comprehensive Cancer Network indicate that either laparotomy (open surgery) or laparoscopy (minimally invasive surgery performed with either conventional or robotic techniques) is an acceptable approach to radical resection in patients with early- and medium stage (I to III) colorectal cancer. These recommendations have led to widespread use of a minimally invasive approach for radical resection, although there is a paucity of adequately powered, prospective, randomized trials evaluating short term and survival outcomes.
Retrospective studies involving patients with early and medium-stage colorectal cancer have shown that laparoscopic resection is associated with less intraoperative blood loss, a shorter length of hospital stay, and a lower risk of postoperative complications than open abdominal radical resection. Similarly, the minimally invasive approach has not been associated with lower 5-year rates of disease-free survival or overall survival than the open approach. In addition, retrospective studies have shown that recurrence rates and survival rates do not differ significantly between the two approaches.
The investigators hypothesized that minimally invasive surgery was not inferior or superior to open radical resection in terms of short-term and long-term outcome. In the present trial, the Laparoscopic Resection and Laparotomy for Colorectal Cancer (LRLCC) Trial, the investigators tested this hypothesis by prospectively assigning patients to minimally invasive (conventional laparoscopic or robotic) or open abdominal radical surgery and comparing the short-term outcome, the rate of recurrence, and the overall survival rate between the two groups.
- Conditions
- Laparoscopy
- Being tested
- minimally invasive surgery
- Keywords
- laparoscopy,laparotomy,colorectal cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive surgeryProcedure or surgery
Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. No individual surgeons performed only the open approach or only the minimally invasive approach. The committee members reviewed the patients' outcomes and the videos to ensure the adequacy of the surgeon's technique.
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive surgery | Experimental | Patients were randomized to undergo minimally invasive radical resection (endoscopic surgery or robotic assisted surgery). Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery.
Patients were eligible if they had colorectal adenocarcinoma; had a disease stage of I (T1,T2), IIABC (T3-T4ab) or IIIABC (TanyN1-2) according to the staging system of NCCN; and had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher values indicating greater disability). Receives: Procedure: minimally invasive surgery |
| open surgery | No intervention | Patients were randomized to undergo open radical resection (laparotomy). Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. Patients were eligible if they had colorectal adenocarcinoma; had a disease stage of I (T1,T2), IIABC (T3-T4ab) or IIIABC (TanyN1-2) according to the staging system of NCCN; and had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher values indicating greater disability). Exclusion criteria included a history of abdominal or pelvic radiotherapy, or evidence of metastatic disease on positron-emission tomography-computed tomography, magnetic resonance imaging, or computed tomography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
complications includes intraoperative and postoperative complications, such as huge blood loss, anastomotic fistula, abdominal infection and septic shock.
Measured: through hospital stay, an average of two weeks
disease free survival
Disease-free survival (DFS) was defined as the interval between the date of surgical resection and diagnosis of recurrence or the most recent follow-up date.
Measured: From date of randomization until the date of first documented progression, assessed up to 70 months
overall survival
Overall survival (OS) was measured from the date of hepatectomy to death with or without HCC recurrence or the end of this study period.
Measured: From date of randomization until the date of death from any cause, assessed up to 70 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start15 Feb 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- multicenter, randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Zhejiang University, Peking University Cancer Hospital & Institute, Zhengzhou University, Peking Union Medical College, Sun Yat-sen University, Fudan University, Shanghai Jiao Tong University School of Medicine, Massachusetts General Hospital, Harvard Medical School (HMS and HSDM), M.D. Anderson Cancer Center, University of California, Los Angeles, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Dalu M Kong, M.D., Study director, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837782
- Sponsor's protocol ID
- LRLCC
- Acronym
- LRLCC
- Status last verified
- Jan 2019
- First submitted
- 31 Jan 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Versus Abdominal Radical Resection for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03837782
- Acronym / sponsor ID
- LRLCC / LRLCC
- Conditions
- Laparoscopy
- Keywords
- laparoscopy,laparotomy,colorectal cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Zhejiang University, Peking University Cancer Hospital & Institute, Zhengzhou University, Peking Union Medical College, Sun Yat-sen University, Fudan University, Shanghai Jiao Tong University School of Medicine, Massachusetts General Hospital, Harvard Medical School (HMS and HSDM), M.D. Anderson Cancer Center, University of California, Los Angeles, University of Pennsylvania
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Feb 2019 (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.
There are limited data from retrospective studies regarding whether short-term and long-term outcomes after laparoscopic or robot-assisted radical colectomy (minimally invasive surgery) are equivalent to those after open abdominal radical colectomy (open surgery) among patients with early and medium-stage colorectal cancer.
This trial is a multicenter,prospective, randomized trial evaluating short-term and survival outcomes concerning minimally invasive surgery and open surgery for colorectal cancer.
Detailed description
Radical colectomy and proctectomy with regional lymphadenectomy remain the standard recommendation for patients with early and medium-stage colorectal cancer. Current guidelines from the National Comprehensive Cancer Network indicate that either laparotomy (open surgery) or laparoscopy (minimally invasive surgery performed with either conventional or robotic techniques) is an acceptable approach to radical resection in patients with early- and medium stage (I to III) colorectal cancer. These recommendations have led to widespread use of a minimally invasive approach for radical resection, although there is a paucity of adequately powered, prospective, randomized trials evaluating short term and survival outcomes.
Retrospective studies involving patients with early and medium-stage colorectal cancer have shown that laparoscopic resection is associated with less intraoperative blood loss, a shorter length of hospital stay, and a lower risk of postoperative complications than open abdominal radical resection. Similarly, the minimally invasive approach has not been associated with lower 5-year rates of disease-free survival or overall survival than the open approach. In addition, retrospective studies have shown that recurrence rates and survival rates do not differ significantly between the two approaches.
The investigators hypothesized that minimally invasive surgery was not inferior or superior to open radical resection in terms of short-term and long-term outcome. In the present trial, the Laparoscopic Resection and Laparotomy for Colorectal Cancer (LRLCC) Trial, the investigators tested this hypothesis by prospectively assigning patients to minimally invasive (conventional laparoscopic or robotic) or open abdominal radical surgery and comparing the short-term outcome, the rate of recurrence, and the overall survival rate between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, randomized trial
| Arm | Type | Receives |
|---|---|---|
| minimally invasive surgery | Experimental | Procedure: minimally invasive surgeryPatients were randomized to undergo minimally invasive radical resection (endoscopic surgery or robotic assisted surgery). Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. Patients were eligible if they had colorectal adenocarcinoma; had a disease stage of I (T1,T2), IIABC (T3-T4ab) or IIIABC (TanyN1-2) according to the staging system of NCCN; and had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher values indicating greater disability). |
| open surgery | No intervention | –Patients were randomized to undergo open radical resection (laparotomy). Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. Patients were eligible if they had colorectal adenocarcinoma; had a disease stage of I (T1,T2), IIABC (T3-T4ab) or IIIABC (TanyN1-2) according to the staging system of NCCN; and had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher values indicating greater disability). Exclusion criteria included a history of abdominal or pelvic radiotherapy, or evidence of metastatic disease on positron-emission tomography-computed tomography, magnetic resonance imaging, or computed tomography. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- tumor without distant metastasis; (ii) classified as stage I, II or III by TNM staging system; (iii) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; (iv) a minimum of 12 lymph nodes resected to accurately identify stage; (v) solitary malignant lesion after thorough colonoscopy; (vi) complete resection (R0) with no positive nodes left behind; (vii) histological diagnosis of adenocarcinoma.
Key exclusion criteria (1 listed)
- <18 years or >90 years; (ii) serious concurrent illness; (iii) clinically suspicious distant metastasis detected by positron emission tomography-computed tomography (PET-CT); (iv) familial adenomatous polyposis syndrome (FAP), hereditary non-polyposis colorectal cancer (HNPCC) and other hereditary CRC; (v) postoperative pathological close, indeterminate, or positive margins; (vi) circumferential resection margin < 1mm in rectal cancer; (vii) short anticipated life expectancy due to postoperative comorbidities on account of cardiopulmonary insufficiency.
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 |
|---|---|---|
| minimally invasive surgeryEach participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. No individual surgeons performed only the open approach or only the minimally invasive approach. The committee members reviewed the patients' outcomes and the videos to ensure the adequacy of the surgeon's technique. | Procedure or surgery | minimally invasive surgery |
Primary outcome
complications
Time frame: through hospital stay, an average of two weeks
complications includes intraoperative and postoperative complications, such as huge blood loss, anastomotic fistula, abdominal infection and septic shock.
disease free survival
Time frame: From date of randomization until the date of first documented progression, assessed up to 70 months
Disease-free survival (DFS) was defined as the interval between the date of surgical resection and diagnosis of recurrence or the most recent follow-up date.
overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 70 months.
Overall survival (OS) was measured from the date of hepatectomy to death with or without HCC recurrence or the end of this study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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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.
Dalu M Kong, M.D. study director
Tianjin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive surgery in people with Laparoscopy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 12 Feb 2019. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications (time frame: through hospital stay, an average of two weeks). The study lists 3 primary outcomes in all. 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 12 Feb 2019.