Effect of Preserving the Left Colic Artery on Proximal Bowel Perfusion

NCT06982664 | Not Yet Recruiting DMC

• 1 other identifier: KY2025PJ104
• Study Type: interventional
• Target: 143
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Cancer Surgery; Perfusion Imaging; Anastomosis, Leaking

Keywords

rectal caner; Perfusion; Anastomosis leakage; Laser Speckle Contrast Imaging

Outcome Measures

Primary Outcomes (1)

• Maximum Perfusion Distance (MPD)

  Determined by measuring the distance from the ischemic line of demarcation to the starting point of the sigmoid colon.

  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

  Perioperative

• Speckle Flow Index (SFI) at the Proximal Anastomosis Site Measured by Laser Speckle Contrast Imaging (LSCI)

  Perioperative

• Ischemic Demarcation Line (LOD) Retraction Distance

  Perioperative

Other Outcomes (6)

• Intraoperative blood loss

  Perioperative

• Operative time

  Perioperative

• Intraoperative blood transfusion

  Perioperative

Study Arms (2)

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.

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.

Procedure: Low Tie of Inferior Mesenteric Artery

Interventions

High Tie of Inferior Mesenteric Artery 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

HT Group

Low Tie of Inferior Mesenteric Artery 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.

LT Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead

Study Officials

• Jiazi Yu, M.D.

  Ningbo Medical Center of Lihuili Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiazi Yu, M.D.

CONTACT

86+13456138978; lhlyujiazi@nbu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study employs single-blinding where patients are unaware of their treatment allocation (High Tie \[HT\] or Low Tie \[LT\]). The operating surgeon is necessarily unblinded intraoperatively to perform the assigned surgical technique. The statistician(s) performing the data analysis will be masked to treatment group assignments until the analysis is complete. Randomization is managed by a designated investigator using pre-generated random numbers after eligibility confirmation (1:1 ratio to HT or LT group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the study results and will remain available for a period of 3 years.
• Access Criteria: Qualified researchers affiliated with academic institutions, hospitals, or research organizations may request access to the de-identified individual participant data (IPD), study protocol, and statistical analysis plan. Data will be shared for research purposes only, following submission and approval of a research proposal and data access agreement.