Right Colic LymphadenopathyPhase 2/3NCT03329495
Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach Orientated by SMA or SMV
A Phase 2/3 study testing SMA-orientated right hemicoloectomy and SMV-orientated right hemicoloectomy in people with Right Colic Lymphadenopathy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
A randomized controlled clinical trial to compare the outcomes of SMA- and SMV- orientated laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Right Colic Lymphadenopathy
- What is being tested?
- SMA-orientated right hemicoloectomy and SMV-orientated right hemicoloectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2018to Jan 2023
- Phase
- Phase 2/3
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suitable for curative surgery between 18 - 85 years old;
- American Society of Anesthesiologists(ASA) grade I-III;
- Preoperative pathological diagnosis of adenocarcinoma;
- Tumor located at the right colon;
- Informed consent;
- No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
Who cannot join
- Pregnant patient;
- History of psychiatric disease;
- Use of systemic steroids;
- Simultaneous multiple primary colorectal cancer;
- Preoperative enhanced CT scan of chest, abdominal and pelvic cavity shows:
- Tumor involves the surrounding organs and combined organ resection needed to be done;
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- distant metastasis;
- unable to perform R0 resection;
- History of any other malignant tumor in recent 5 years;
- Patients need emergency operation: mechanic ileus, perforation.
- Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
- Conversion from laparoscopic surgery to laparotomy;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial to Investigate the Effect of SMA- or SMV- Orientated Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach
A randomized controlled clinical trial to compare the outcomes of SMA- and SMV- orientated laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach
Read the detailed description
In 2008, Germany scholar W. Hohenberger proposed the idea of complete mesocolic excision (CME) and central vascular ligation (CVL) for the standardization of colonic cancer surgery. This concept has been widely recognized and accepted. This radical operation attempts to remove the mesocolon intactly by careful dissection along the embryologic tissue planes and transection of the supplying vessels at their origin. For right-sided colon cancer, this approach involves division of the vessels at their origin from the superior mesenteric artery (SMA) and superior mesenteric vein (SMV). In our opinion, full exposure of the SMA and SMV is necessary to make sure that the origin of the colonic arteries being truly exposed and tied centrally at their origin and a maximal harvest of the regional lymphnodes. For locally advanced colon cancer, SMA- orientated surgery may be more meaningful to recerve a radical lymphadenectomy and bring benefit for their survival. However, in the traditional practise, the lymph node dissection is orientated by SMV and SMA is not exposed, tissue around SMA is left behind.
In this study, eligible patients with right colon cancer will be randomly allocated to receive either SMA- or SMV- orientated laparoscopic right hemicoloectomy. 100 patients will be enrolled in each group. In SMV- orientated surgery group, SMA is not exposed and the left boundary of resection is the left side of SMV. In SMA- orientated surgery group, the left boundary of resection is the left side of SMA and SMA is exposed.Artery sheath is not necessarily to be opened. Postoperative pathology will be analyzed with the number of lymph nodes retrieved. Postoperative recovery process and long term survival will be followed.
- Conditions
- Right Colic Lymphadenopathy
- Being tested
- SMA-orientated right hemicoloectomy, SMV-orientated right hemicoloectomy
- Keywords
- right colon cancer, superior mesenteric artery, superior mesenteric vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMA-orientated right hemicoloectomyProcedure or surgery
Laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMA. The left boundary of resection is the left side of SMA, and artery sheath is not necessarily being opened.
SMV-orientated right hemicoloectomyProcedure or surgery
Laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMV. The left boundary of resection is the left side of SMV, and SMA is not exposed.
| Study group | Role | What they receive |
|---|---|---|
| SMA-orientated right hemicoloectomy | Active comparator | SMA-orientated right hemicoloectomy Receives: Procedure: SMA-orientated right hemicoloectomy |
| SMV-orientated right hemicoloectomy | Experimental | SMV-orientated right hemicoloectomy Receives: Procedure: SMV-orientated right hemicoloectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of lymph nodes retrieved
Measured: 1 day
Secondary outcomes (5)
disease-free survival
Measured: 3 years
overall survival
Measured: 3 years
recurrence-free survival
Measured: 3 years
early complication rate
Early complication is defined as a complication that occurred between the finish of the surgery and postoperative day. Complications includes anastomotic leakage, anastomotic bleeding, chyle leakage, wound infection, pulmonary embolism, myocardial infarction et al.The Clavien-Dindo Classification of Surgical Complications will be applied to access the degree of severity of postoperative complications.
Measured: 30 days
operative time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Colic LymphadenopathyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fumin Zhang, Professor, Principal investigator, Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329495
- Sponsor's protocol ID
- CRSYM201710
- Status last verified
- Oct 2017
- First submitted
- 30 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial to Investigate the Effect of SMA- or SMV- Orientated Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach
- ClinicalTrials.gov ID
- NCT03329495
- Acronym / sponsor ID
- CRSYM201710
- Conditions
- Right Colic Lymphadenopathy
- Keywords
- right colon cancer, superior mesenteric artery, superior mesenteric vein
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 6 Nov 2017 (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.
A randomized controlled clinical trial to compare the outcomes of SMA- and SMV- orientated laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach
Detailed description
In 2008, Germany scholar W. Hohenberger proposed the idea of complete mesocolic excision (CME) and central vascular ligation (CVL) for the standardization of colonic cancer surgery. This concept has been widely recognized and accepted. This radical operation attempts to remove the mesocolon intactly by careful dissection along the embryologic tissue planes and transection of the supplying vessels at their origin. For right-sided colon cancer, this approach involves division of the vessels at their origin from the superior mesenteric artery (SMA) and superior mesenteric vein (SMV). In our opinion, full exposure of the SMA and SMV is necessary to make sure that the origin of the colonic arteries being truly exposed and tied centrally at their origin and a maximal harvest of the regional lymphnodes. For locally advanced colon cancer, SMA- orientated surgery may be more meaningful to recerve a radical lymphadenectomy and bring benefit for their survival. However, in the traditional practise, the lymph node dissection is orientated by SMV and SMA is not exposed, tissue around SMA is left behind.
In this study, eligible patients with right colon cancer will be randomly allocated to receive either SMA- or SMV- orientated laparoscopic right hemicoloectomy. 100 patients will be enrolled in each group. In SMV- orientated surgery group, SMA is not exposed and the left boundary of resection is the left side of SMV. In SMA- orientated surgery group, the left boundary of resection is the left side of SMA and SMA is exposed.Artery sheath is not necessarily to be opened. Postoperative pathology will be analyzed with the number of lymph nodes retrieved. Postoperative recovery process and long term survival will be followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMA-orientated right hemicoloectomy | Active comparator | Procedure: SMA-orientated right hemicoloectomySMA-orientated right hemicoloectomy |
| SMV-orientated right hemicoloectomy | Experimental | Procedure: SMV-orientated right hemicoloectomySMV-orientated right hemicoloectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients suitable for curative surgery between 18 - 85 years old;
- American Society of Anesthesiologists(ASA) grade I-III;
- Preoperative pathological diagnosis of adenocarcinoma;
- Tumor located at the right colon;
- Informed consent;
Key exclusion criteria (12 listed)
- Pregnant patient;
- History of psychiatric disease;
- Use of systemic steroids;
- Simultaneous multiple primary colorectal cancer;
- Preoperative enhanced CT scan of chest, abdominal and pelvic cavity shows:
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 |
|---|---|---|
| SMA-orientated right hemicoloectomyLaparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMA. The left boundary of resection is the left side of SMA, and artery sheath is not necessarily being opened. | Procedure or surgery | SMA-orientated right hemicoloectomy |
| SMV-orientated right hemicoloectomyLaparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMV. The left boundary of resection is the left side of SMV, and SMA is not exposed. | Procedure or surgery | SMV-orientated right hemicoloectomy |
Primary outcome
number of lymph nodes retrieved
Time frame: 1 day
5 secondary outcomes
disease-free survival
Time frame: 3 years
overall survival
Time frame: 3 years
recurrence-free survival
Time frame: 3 years
early complication rate
Time frame: 30 days
operative time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: Undecided
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.
Fumin Zhang, Professor principal investigator
Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SMA-orientated right hemicoloectomy and SMV-orientated right hemicoloectomy in people with Right Colic Lymphadenopathy, run by The First Affiliated Hospital with Nanjing Medical University 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 6 inclusion and 12 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 6 Nov 2017. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yueming Sun, PhD (02568136026, jssym@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of lymph nodes retrieved (time frame: 1 day). 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 6 Nov 2017.