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Not yet recruiting NCT06982664

Effect of Preserving the Left Colic Artery on Proximal Bowel Perfusion

No phase Interventional Rectal Cancer Surgery Perfusion Imaging Anastomosis, Leaking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Tie of Inferior Mesenteric Artery, Low Tie of Inferior Mesenteric Artery.
Who it may be relevant to
Registry conditions: Rectal Cancer Surgery, Perfusion Imaging, Anastomosis, Leaking. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Procedure High Tie of Inferior Mesenteric Artery
    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
  • Procedure Low Tie of Inferior Mesenteric Artery
    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.

Primary outcome measures

  • Maximum Perfusion Distance (MPD) [Time frame: Perioperative]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

  • a confirmed diagnosis based on pathological reports;
  • patients who had not received any prior treatment;

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06982664 · KY2025PJ104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗