Rectal Cancer SurgeryNCT06982664
Effect of Preserving the Left Colic Artery on Proximal Bowel Perfusion
A study testing High Tie of Inferior Mesenteric Artery and Low Tie of Inferior Mesenteric Artery in people with Rectal Cancer Surgery and Perfusion Imaging, run by Ningbo Medical Center Lihuili Hospital.
Trial summary
Patients with rectal or rectosigmoid cancer undergoing radical resection will be randomly assigned to either high-tie (HT) or low-tie (LT) ligation of the Inferior Mesenteric Artery (IMA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer Surgery, Perfusion Imaging, Anastomosis, Leaking
- What is being tested?
- High Tie of Inferior Mesenteric Artery and Low Tie of Inferior Mesenteric Artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a confirmed diagnosis based on pathological reports;
- patients who had not received any prior treatment;
Who cannot join
- a history of previous abdominal surgery or neoadjuvant chemotherapy/radiation affecting bowel perfusion or anastomosis;
- patients requiring emergency surgery due to acute complications;
- intraoperative findings necessitating a shift to alternative procedures, such as local excision, abdominoperineal resection, Hartmann's operation, or intersphincteric resection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Preserving the Left Colic Artery on Proximal Bowel and Anastomotic Blood Perfusion During Radical Resection for Rectal Cancer: A Randomized Controlled Trial Based on Laser Speckle Contrast Imaging
Patients with rectal or rectosigmoid cancer undergoing radical resection will be randomly assigned to either high-tie (HT) or low-tie (LT) ligation of the Inferior Mesenteric Artery (IMA). Proximal bowel blood perfusion will be measured using Laser Speckle Contrast Imaging, and the perfusion characteristics will be compared between the two ligation groups.
Additionally, for participants randomized to the LT group, an embedded prospective cohort sub-study will be performed. This sub-study involves controlled, temporary intraoperative occlusion of the preserved Left Colic Artery (LCA). During this temporary occlusion, LSCI will be used to assess the resulting changes in colonic perfusion, specifically measuring outcomes like the ischemic demarcation line (LOD) retraction distance, to further investigate the functional contribution of the preserved LCA. The overall trial aims to determine the optimal IMA ligation strategy based on objective perfusion data and a deeper understanding of LCA's role.
Read the detailed description
The primary goal of this clinical trial is to compare proximal bowel blood perfusion following HT versus LT of the IMA during anterior resection for rectal cancer. LSCI will be used to assess perfusion in both groups.Additionally, this trial incorporates an embedded prospective cohort sub-study, which will be conducted specifically within the LT group, where the Left Colic Artery (LCA) is preserved. The purpose of this sub-study is to further elucidate the impact of this LCA preservation on left colonic perfusion in these patients. This will be achieved by investigating the retraction distance of the ischemic demarcation line following temporary occlusion of the preserved LCA under LSCI guidance, and by exploring potential anatomical and pathophysiological factors that may contribute to variations in this retraction distance.
The main questions the study seeks to answer are:
Does HT ligation result in significantly different proximal bowel blood perfusion, as measured by LSCI, compared to LT ligation? Does knowledge of intraoperative bowel perfusion, as assessed by LSCI, influence surgical decision-making, specifically regarding changes to the planned transection line? Are there significant differences in quantified perfusion intensity at the transection line between HT and LT ligation techniques? What is the retraction distance of the ischemic demarcation line, observed via LSCI, following temporary occlusion of the LCA, and what are the potential anatomical or pathophysiological factors associated with variations in this distance? Patients undergoing anterior resection for rectal cancer will be randomized to receive either HT or LT ligation of the IMA. LSCI will be used intraoperatively to assess bowel perfusion.
Participants will:
Undergo anterior resection for either rectal or rectosigmoid cancer, with HT or LT ligation of the IMA determined by the randomization process.
Have bowel perfusion assessed intraoperatively using LSCI. Have the maximum perfusion distance (MPD) measured as the primary outcome for the main randomized trial component.
Have the perfusion intensity at the transection line quantified as a secondary outcome.
Have any changes to the planned transection line documented based on intraoperative LSCI findings, as a secondary outcome.
As part of the embedded prospective cohort sub-study, undergo temporary intraoperative occlusion of the LCA with subsequent LSCI assessment to measure the retraction distance of the ischemic demarcation line.
As part of the embedded prospective cohort sub-study, have data collected on relevant potential anatomical (e.g., vascular anatomy variations) and pathophysiological factors (e.g., presence of atherosclerosis, patient comorbidities) that may influence the ischemic demarcation line retraction distance.
This trial aims to provide high-level evidence to inform and optimize IMA management strategies during anterior resection for rectal or rectosigmoid cancer, based on proximal bowel perfusion assessment using LSCI visualization, and to provide deeper mechanistic insights into the specific role and functional importance of the LCA in maintaining colonic perfusion.
- Being tested
- High Tie of Inferior Mesenteric Artery, Low Tie of Inferior Mesenteric Artery
- Keywords
- rectal caner, Perfusion, Anastomosis leakage, Laser Speckle Contrast Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Tie of Inferior Mesenteric ArteryProcedure or surgery
IMA was ligated approximately 1 cm from its origin after dissection of the surrounding tissue to ensure clear visualization of the IMA root. Using this technique, the LCA and the inferior mesenteric vein were ligated near the lower border of the pancreas
Low Tie of Inferior Mesenteric ArteryProcedure or surgery
During this procedure, the LCA was identified and preserved, and the superior rectal artery was ligated. Before colonic transection or anastomosis, the preserved LCA underwent temporary, controlled occlusion. After assessing perfusion changes using LSCI, the occlusion was released to restore blood flow.
| Study group | Role | What they receive |
|---|---|---|
| HT Group | Experimental | In this group, the IMA was ligated approximately 1 cm from its origin. With this approach, both the LCA and the inferior mesenteric vein were ligated near the lower border of the pancreas. Receives: Procedure: High Tie of Inferior Mesenteric Artery |
| LT Group | Experimental | In the LT group, apical lymph node dissection was performed around the origin of the IMA. During this procedure, the LCA was identified and preserved and the superior rectal artery was ligated. Receives: Procedure: Low Tie of Inferior Mesenteric Artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Perfusion Distance (MPD)
Determined by measuring the distance from the ischemic line of demarcation to the starting point of the sigmoid colon.
Measured: Perioperative
Secondary outcomes (3)
Number of participants requiring revision of the planned bowel transection line following intraoperative Laser Speckle Contrast Imaging (LSCI)-based bowel perfusion assessment
This measure quantifies the number of participants whose planned bowel transection line, initially determined by conventional intraoperative assessment (e.g., visual inspection, serosal sheen, peristalsis, mesenteric pulse palpation), is revised after LSCI is used to assess bowel perfusion. Revisions occur under two conditions:
- The initial transection line was planned distal to the Line of Demarcation (LOD) indicated by LSCI, and the surgeon adjusts the transection line based on the LSCI findings (typically moving it proximally).
- The initial transection line was planned proximal to the LSCI-indicated LOD, but the surgeon determines it must be moved distally to ensure a tension-free anastomosis.
If the initial transection line is proximal to the LSCI LOD and bowel length is sufficient for a tension-free anastomosis, no revision is counted. Data will be reported as the total count and percentage of participants who meet the revision criteria.
Measured: Perioperative
Speckle Flow Index (SFI) at the Proximal Anastomosis Site Measured by Laser Speckle Contrast Imaging (LSCI)
This measure reports the microvascular blood perfusion at the planned proximal bowel anastomosis site, assessed intraoperatively using Laser Speckle Contrast Imaging (LSCI) and SIM BFI Software (V2.0). The metric used is the Speckle Flow Index (SFI), a numerical value calculated by the software.
The SFI quantifies the relative speed of red blood cells in the tissue, derived from 50 consecutive image frames with a 10 ms exposure time. While LSCI also generates real-time 2D perfusion maps for visual guidance, this measure focuses on the SFI value alone.
The SFI is reported as a numerical value, typically in arbitrary perfusion units (APU) or relative units. Statistical analysis will summarize these SFI values across participants, reporting measures such as mean, median, and standard deviation.
Measured: Perioperative
Ischemic Demarcation Line (LOD) Retraction Distance
This outcome measure will be assessed exclusively in participants randomized to the LT group. Before temporarily occluding the preserved LCA, the initial LOD will be identified using LSCI and marked. Then, the LCA will be temporarily occluded using a non-damaging vascular clamp. LSCI will be used again to visualize colonic perfusion and identify the new LOD. The LOD retraction distance is defined as the proximal distance along the bowel from the previously established reference point to the new LOD identified via LSCI. This measurement will be recorded in centimeters (cm).
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were categorized into two groups, HT and LT, based on the planned management of the IMA. HT Group: In the HT group, the IMA was ligated approximately 1 cm from its origin after meticulous dissection of the surrounding tissue to ensure clear visualization of the IMA root. LT Group: In the LT group, the surgical approach focused on preserving the LCA. Apical lymph node dissection was performed around the origin of the IMA. The superior rectal artery was ligated distal to the origin of the LCA. As part of the prospective cohort sub-study in the LT group, the preserved LCA underwent temporary, controlled occlusion intraoperatively. This was done after confirming LCA preservation and before colonic transection or anastomosis. The aim was to assess perfusion changes-such as retraction of the ischemic demarcation line using LSCI-to evaluate the functional role of the LCA. After assessment, the occlusion was released to restore blood flow.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jiazi Yu, M.D., Study director, Ningbo Medical Center of Lihuili Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982664
- Sponsor's protocol ID
- KY2025PJ104
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data generated in this study will be made available in the main publication or its supplementary materials. Additional de-identified datasets will be shared upon reasonable request from qualified researchers after completion of the study and approval by the institutional ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preserving the Left Colic Artery on Proximal Bowel and Anastomotic Blood Perfusion During Radical Resection for Rectal Cancer: A Randomized Controlled Trial Based on Laser Speckle Contrast Imaging
- ClinicalTrials.gov ID
- NCT06982664
- Acronym / sponsor ID
- KY2025PJ104
- Keywords
- rectal caner, Perfusion, Anastomosis leakage, Laser Speckle Contrast Imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 May 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.
Patients with rectal or rectosigmoid cancer undergoing radical resection will be randomly assigned to either high-tie (HT) or low-tie (LT) ligation of the Inferior Mesenteric Artery (IMA). Proximal bowel blood perfusion will be measured using Laser Speckle Contrast Imaging, and the perfusion characteristics will be compared between the two ligation groups.
Additionally, for participants randomized to the LT group, an embedded prospective cohort sub-study will be performed. This sub-study involves controlled, temporary intraoperative occlusion of the preserved Left Colic Artery (LCA). During this temporary occlusion, LSCI will be used to assess the resulting changes in colonic perfusion, specifically measuring outcomes like the ischemic demarcation line (LOD) retraction distance, to further investigate the functional contribution of the preserved LCA. The overall trial aims to determine the optimal IMA ligation strategy based on objective perfusion data and a deeper understanding of LCA's role.
Detailed description
The primary goal of this clinical trial is to compare proximal bowel blood perfusion following HT versus LT of the IMA during anterior resection for rectal cancer. LSCI will be used to assess perfusion in both groups.Additionally, this trial incorporates an embedded prospective cohort sub-study, which will be conducted specifically within the LT group, where the Left Colic Artery (LCA) is preserved. The purpose of this sub-study is to further elucidate the impact of this LCA preservation on left colonic perfusion in these patients. This will be achieved by investigating the retraction distance of the ischemic demarcation line following temporary occlusion of the preserved LCA under LSCI guidance, and by exploring potential anatomical and pathophysiological factors that may contribute to variations in this retraction distance.
The main questions the study seeks to answer are:
Does HT ligation result in significantly different proximal bowel blood perfusion, as measured by LSCI, compared to LT ligation? Does knowledge of intraoperative bowel perfusion, as assessed by LSCI, influence surgical decision-making, specifically regarding changes to the planned transection line? Are there significant differences in quantified perfusion intensity at the transection line between HT and LT ligation techniques? What is the retraction distance of the ischemic demarcation line, observed via LSCI, following temporary occlusion of the LCA, and what are the potential anatomical or pathophysiological factors associated with variations in this distance? Patients undergoing anterior resection for rectal cancer will be randomized to receive either HT or LT ligation of the IMA. LSCI will be used intraoperatively to assess bowel perfusion.
Participants will:
Undergo anterior resection for either rectal or rectosigmoid cancer, with HT or LT ligation of the IMA determined by the randomization process.
Have bowel perfusion assessed intraoperatively using LSCI. Have the maximum perfusion distance (MPD) measured as the primary outcome for the main randomized trial component.
Have the perfusion intensity at the transection line quantified as a secondary outcome.
Have any changes to the planned transection line documented based on intraoperative LSCI findings, as a secondary outcome.
As part of the embedded prospective cohort sub-study, undergo temporary intraoperative occlusion of the LCA with subsequent LSCI assessment to measure the retraction distance of the ischemic demarcation line.
As part of the embedded prospective cohort sub-study, have data collected on relevant potential anatomical (e.g., vascular anatomy variations) and pathophysiological factors (e.g., presence of atherosclerosis, patient comorbidities) that may influence the ischemic demarcation line retraction distance.
This trial aims to provide high-level evidence to inform and optimize IMA management strategies during anterior resection for rectal or rectosigmoid cancer, based on proximal bowel perfusion assessment using LSCI visualization, and to provide deeper mechanistic insights into the specific role and functional importance of the LCA in maintaining colonic perfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were categorized into two groups, HT and LT, based on the planned management of the IMA. HT Group: In the HT group, the IMA was ligated approximately 1 cm from its origin after meticulous dissection of the surrounding tissue to ensure clear visualization of the IMA root. LT Group: In the LT group, the surgical approach focused on preserving the LCA. Apical lymph node dissection was performed around the origin of the IMA. The superior rectal artery was ligated distal to the origin of the LCA. As part of the prospective cohort sub-study in the LT group, the preserved LCA underwent temporary, controlled occlusion intraoperatively. This was done after confirming LCA preservation and before colonic transection or anastomosis. The aim was to assess perfusion changes-such as retraction of the ischemic demarcation line using LSCI-to evaluate the functional role of the LCA. After assessment, the occlusion was released to restore blood flow.
| Arm | Type | Receives |
|---|---|---|
| HT Group | Experimental | Procedure: High Tie of Inferior Mesenteric ArteryIn this group, the IMA was ligated approximately 1 cm from its origin. With this approach, both the LCA and the inferior mesenteric vein were ligated near the lower border of the pancreas. |
| LT Group | Experimental | Procedure: Low Tie of Inferior Mesenteric ArteryIn the LT group, apical lymph node dissection was performed around the origin of the IMA. During this procedure, the LCA was identified and preserved and the superior rectal artery was ligated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a confirmed diagnosis based on pathological reports;
- patients who had not received any prior treatment;
Key exclusion criteria (3 listed)
- a history of previous abdominal surgery or neoadjuvant chemotherapy/radiation affecting bowel perfusion or anastomosis;
- patients requiring emergency surgery due to acute complications;
- intraoperative findings necessitating a shift to alternative procedures, such as local excision, abdominoperineal resection, Hartmann's operation, or intersphincteric resection.
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 |
|---|---|---|
| High Tie of Inferior Mesenteric ArteryIMA was ligated approximately 1 cm from its origin after dissection of the surrounding tissue to ensure clear visualization of the IMA root. Using this technique, the LCA and the inferior mesenteric vein were ligated near the lower border of the pancreas | Procedure or surgery | HT Group |
| Low Tie of Inferior Mesenteric ArteryDuring this procedure, the LCA was identified and preserved, and the superior rectal artery was ligated. Before colonic transection or anastomosis, the preserved LCA underwent temporary, controlled occlusion. After assessing perfusion changes using LSCI, the occlusion was released to restore blood flow. | Procedure or surgery | LT Group |
Primary outcome
Maximum Perfusion Distance (MPD)
Time frame: Perioperative
Determined by measuring the distance from the ischemic line of demarcation to the starting point of the sigmoid colon.
3 secondary outcomes
Number of participants requiring revision of the planned bowel transection line following intraoperative Laser Speckle Contrast Imaging (LSCI)-based bowel perfusion assessment
Time frame: Perioperative
Speckle Flow Index (SFI) at the Proximal Anastomosis Site Measured by Laser Speckle Contrast Imaging (LSCI)
Time frame: Perioperative
Ischemic Demarcation Line (LOD) Retraction Distance
Time frame: Perioperative
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 21 May 2025.
- Individual participant dataSharing planned: Yes. All data generated in this study will be made available in the main publication or its supplementary materials. Additional de-identified datasets will be shared upon reasonable request from qualified researchers after completion of the study and approval by the institutional ethics committee.
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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.
Jiazi Yu, M.D. study director
Ningbo Medical Center of Lihuili Hospital
Questions about this trial
What is this clinical trial studying?
A study testing High Tie of Inferior Mesenteric Artery and Low Tie of Inferior Mesenteric Artery in people with Rectal Cancer Surgery and Perfusion Imaging, run by Ningbo Medical Center Lihuili Hospital.
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 2 inclusion and 3 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 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jiazi Yu, M.D. (86+13456138978, lhlyujiazi@nbu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Perfusion Distance (MPD) (time frame: Perioperative). 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 21 May 2025.