Colorectal Cancer (CRC)COLAP-D3NCT06938490
Study of Colorectal Anastomosis Failures With First Sigmoid or Left Colonic Artery Preservation With D3 Lymphadenectomy
A study testing Anterior rectal resection with D3-lymphatic dissection in people with Colorectal Cancer (CRC) and Surgery, Colorectal, run by the BELOOSTROV Clinic of High Technologies at 1 site in Russia.
Trial summary
This study is a randomized, controlled trial comparing the short- and long-term outcomes of left colonic artery or first sigmoid artery preservation for rectal surgery. Eligible patients will be randomized to D3-lymphodissection with preservation of the first sigmoid artery or left colonic artery in a 1:1 ratio… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer (CRC), Surgery, Colorectal, Oncology
- What is being tested?
- Anterior rectal resection with D3-lymphatic dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 778 participants
- Where
- 1 siteRussia
- Study dates
- Apr 2025to May 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent form
- ECOG status is 0-2.
- Age over 18 years
- TNM stage according to version VIII T1b-4aN0-2M0 (M1 in case of resectable metastases confirmed by preoperative staging (colonoscopy, chest and abdominal CT).
- Histologically confirmed adenocarcinoma of the colon, the proximal edge of which is not higher than or equal to 20 cm from the anus
- Clinical indications for colorectal resection with anastomosis formation
Who cannot join
- Medical or psychiatric reasons affecting the patient's decision to participate in the study
- Pregnancy or breastfeeding
- Medical conditions contraindicated for surgery
- Synchronous or metachronous malignancies
- Acute intestinal obstruction, bleeding or perforation
- Preplanned obstructive bowel resection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Timur Lankov The head of the Department of Abdominal and Thoracic Oncology contact
Russia1 site
Beloostrov Clinic High Tech
Saint Petersburg
Timur Lankov, +79046077444, Dr@TimLankov.ru
Anastasia Lavrenteva
About this study
Official title: A Randomized Multicenter Prospective Study of Colorectal Anastomosis Failures With First Sigmoid or Left Colonic Artery Preservation With D3 Lymphadenectomy (COLAP-D3 - Colorectal Anastomotic Leakage and Arterial Preservation With D3 Lymphadenectomy)
This study is a randomized, controlled trial comparing the short- and long-term outcomes of left colonic artery or first sigmoid artery preservation for rectal surgery. Eligible patients will be randomized to D3-lymphodissection with preservation of the first sigmoid artery or left colonic artery in a 1:1 ratio according to a computer-generated randomization list created in advance (includes removal of 252, 253 l/u groups, 241 groups of distal sigmoid colon sites when the neoplasm is highly located).
The operation involves removal of the tumor with oncologically adequate clearance, adherence to the principles of operation in embryonic layers.
Read more
The criterion for performing D3-lymphodissection is visualization of the site of the inferior mesenteric artery (IMA) branching from the aorta. During the surgical intervention, l/u groups 252 and 253 are elevated along the superior rectus artery, the NBA is skeletonized circularly so that there are no l/u and no visible areas of fatty tissue.
In the group with preservation of the left colonic artery, the NBA is isolated, clipped and crossed immediately after the LCA, and in the group with preservation of the first SA, the NBA is skeletonized to the level of the first sigmoid artery, clipped and crossed immediately after the first sigmoid artery . After the intestinal resection stage, a colorectal anastomosis is formed, information on drain placement.
The primary endpoint is to assess the incidence of IA - communication of the intraluminal compartment of the intestine with the extraluminal compartment, anastomosis leakage in the area of the formed anastomosis - which will be performed at 30 days postoperatively and categorized according to the Clavien-Dindo scale. HA can be diagnosed by MRI, CT with proctography, endoscopic examination, or patient examination (if low anastomoses are formed).
Any adverse event in the postoperative period is also classified according to the Clavien-Dindo scale and recorded in the individual patient's chart.
Each patient will have an individual electronic record (eCRF open clinica.), where individual patient data will be entered and where the data obtained will be stored.
- Conditions
- Colorectal Cancer (CRC), Surgery, Colorectal, Oncology
- Being tested
- Anterior rectal resection with D3-lymphatic dissection
- Keywords
- Anastomotic leakage, Colorectal cancer (CRC), First sigmoid artery (SA), Left colonic artery (LCA)
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior rectal resection with D3-lymphatic dissectionProcedure or surgery
This study aims to determine the incidence of anastomosis failure in the group with first SA and LCA preservation in order to identify the feasibility of manipulation.
The study is unique in that there is only one study in the world that evaluates the incidence of anastomosis failure with preservation of the first sigmoid and there is no study comparing the groups described in this study.
| Study group | Role | What they receive |
|---|---|---|
| LCA preserved | Active comparator | A group of people with only the left colonic artery preserved Receives: Procedure: Anterior rectal resection with D3-lymphatic dissection |
| First SA preserved | Active comparator | A group of people with only the first sigmoid artery preserved Receives: Procedure: Anterior rectal resection with D3-lymphatic dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of colorectal anastomoses within 30 days of surgery
The failure of colorectal anastomosis will be registered in the presence of clinical symptoms confirmed by rectal examination (with low anastomoses) and/or MRI
Measured: 3 years
Secondary outcomes (5)
Assessment of radicality of surgery: number of LU removed
Measured: 3 years
Long-term results: overall and recurrence-free survival at 1 year, 3 and 5 years, respectively, the percentage of three- and five-year survival in the group where sigmoid artery preservation was performed and where it was clipped.
Measured: 3 years
Registration of all deviations from the normal course in the postoperative period
Measured: 3 years
Assessment of radicality of surgery: proximal and distal clearance
Measured: 3 years
Assessment of radicality of surgery: number of R1 resections
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 778 participants (estimated)
Sponsor and investigators
- Lead sponsor
- the BELOOSTROV Clinic of High Technologies
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938490
- Sponsor's protocol ID
- Beloostrov Clinic High Tech
- Acronym
- COLAP-D3
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Prospective Study of Colorectal Anastomosis Failures With First Sigmoid or Left Colonic Artery Preservation With D3 Lymphadenectomy (COLAP-D3 - Colorectal Anastomotic Leakage and Arterial Preservation With D3 Lymphadenectomy)
- ClinicalTrials.gov ID
- NCT06938490
- Acronym / sponsor ID
- COLAP-D3 / Beloostrov Clinic High Tech
- Conditions
- Colorectal Cancer (CRC), Surgery, Colorectal, Oncology
- Keywords
- Anastomotic leakage, Colorectal cancer (CRC), First sigmoid artery (SA), Left colonic artery (LCA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 778 participants (estimated)
- Lead sponsor
- the BELOOSTROV Clinic of High TechnologiesResearch network
- Study start
- Apr 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 22 Apr 2025 (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.
This study is a randomized, controlled trial comparing the short- and long-term outcomes of left colonic artery or first sigmoid artery preservation for rectal surgery. Eligible patients will be randomized to D3-lymphodissection with preservation of the first sigmoid artery or left colonic artery in a 1:1 ratio according to a computer-generated randomization list created in advance (includes removal of 252, 253 l/u groups, 241 groups of distal sigmoid colon sites when the neoplasm is highly located).
The operation involves removal of the tumor with oncologically adequate clearance, adherence to the principles of operation in embryonic layers.
The criterion for performing D3-lymphodissection is visualization of the site of the inferior mesenteric artery (IMA) branching from the aorta. During the surgical intervention, l/u groups 252 and 253 are elevated along the superior rectus artery, the NBA is skeletonized circularly so that there are no l/u and no visible areas of fatty tissue.
In the group with preservation of the left colonic artery, the NBA is isolated, clipped and crossed immediately after the LCA, and in the group with preservation of the first SA, the NBA is skeletonized to the level of the first sigmoid artery, clipped and crossed immediately after the first sigmoid artery . After the intestinal resection stage, a colorectal anastomosis is formed, information on drain placement.
The primary endpoint is to assess the incidence of IA - communication of the intraluminal compartment of the intestine with the extraluminal compartment, anastomosis leakage in the area of the formed anastomosis - which will be performed at 30 days postoperatively and categorized according to the Clavien-Dindo scale. HA can be diagnosed by MRI, CT with proctography, endoscopic examination, or patient examination (if low anastomoses are formed).
Any adverse event in the postoperative period is also classified according to the Clavien-Dindo scale and recorded in the individual patient's chart.
Each patient will have an individual electronic record (eCRF open clinica.), where individual patient data will be entered and where the data obtained will be stored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCA preserved | Active comparator | Procedure: Anterior rectal resection with D3-lymphatic dissectionA group of people with only the left colonic artery preserved |
| First SA preserved | Active comparator | Procedure: Anterior rectal resection with D3-lymphatic dissectionA group of people with only the first sigmoid artery preserved |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent form
- ECOG status is 0-2.
- Age over 18 years
- TNM stage according to version VIII T1b-4aN0-2M0 (M1 in case of resectable metastases confirmed by preoperative staging (colonoscopy, chest and abdominal CT).
- Histologically confirmed adenocarcinoma of the colon, the proximal edge of which is not higher than or equal to 20 cm from the anus
Key exclusion criteria (6 listed)
- Medical or psychiatric reasons affecting the patient's decision to participate in the study
- Pregnancy or breastfeeding
- Medical conditions contraindicated for surgery
- Synchronous or metachronous malignancies
- Acute intestinal obstruction, bleeding or perforation
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 |
|---|---|---|
| Anterior rectal resection with D3-lymphatic dissectionThis study aims to determine the incidence of anastomosis failure in the group with first SA and LCA preservation in order to identify the feasibility of manipulation. The study is unique in that there is only one study in the world that evaluates the incidence of anastomosis failure with preservation of the first sigmoid and there is no study comparing the groups described in this study. | Procedure or surgery | First SA preserved, LCA preserved |
Primary outcome
Failure of colorectal anastomoses within 30 days of surgery
Time frame: 3 years
The failure of colorectal anastomosis will be registered in the presence of clinical symptoms confirmed by rectal examination (with low anastomoses) and/or MRI
5 secondary outcomes
Assessment of radicality of surgery: number of LU removed
Time frame: 3 years
Long-term results: overall and recurrence-free survival at 1 year, 3 and 5 years, respectively, the percentage of three- and five-year survival in the group where sigmoid artery preservation was performed and where it was clipped.
Time frame: 3 years
Registration of all deviations from the normal course in the postoperative period
Time frame: 3 years
Assessment of radicality of surgery: proximal and distal clearance
Time frame: 3 years
Assessment of radicality of surgery: number of R1 resections
Time frame: 3 years
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 22 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Timur Lankov The head of the Department of Abdominal and Thoracic Oncology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior rectal resection with D3-lymphatic dissection in people with Colorectal Cancer (CRC) and Surgery, Colorectal, run by the BELOOSTROV Clinic of High Technologies at 1 site in Russia.
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: opening soon, as of the sponsor's last update on 22 Apr 2025. 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 Russia. 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?
Contact Timur Lankov The head of the Department of Abdominal and Thoracic Oncology (+79046077444, Dr@TimLankov.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of colorectal anastomoses within 30 days of surgery (time frame: 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 22 Apr 2025.