Effect of Preserving the Left Colic Artery on Proximal Bowel Perfusion

NCT ID: NCT06982664

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-06-30

Brief 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). 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.

Conditions

Rectal Cancer Surgery; Perfusion Imaging; Anastomosis, Leaking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HT Group

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.

Group Type: EXPERIMENTAL

High Tie of Inferior Mesenteric Artery

Intervention Type: PROCEDURE

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

LT Group

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.

Group Type: EXPERIMENTAL

Low Tie of Inferior Mesenteric Artery

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. a confirmed diagnosis based on pathological reports;

2. patients who had not received any prior treatment;

Exclusion Criteria

1. a history of previous abdominal surgery or neoadjuvant chemotherapy/radiation affecting bowel perfusion or anastomosis;

2. patients requiring emergency surgery due to acute complications;

3. intraoperative findings necessitating a shift to alternative procedures, such as local excision, abdominoperineal resection, Hartmann's operation, or intersphincteric resection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiazi Yu, M.D.

Role: STUDY_DIRECTOR

Ningbo Medical Center of Lihuili Hospital

Central Contacts

Jiazi Yu, M.D.

Role: CONTACT

lhlyujiazi@nbu.edu.cn

86+13456138978

Other Identifiers

KY2025PJ104

Identifier Type: -

Identifier Source: org_study_id