Application of ICG in Lymph Node Dissection During Radical Resection of Rectal Cancer With Preserved Autonomic Nerves Around LCA and IMA

NCT ID: NCT05517681

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-07
• Study Completion Date: 2022-07-10

Brief Summary

Indocyanine green NIR imaging is valuable for lymph node dissection in D3 radical surgery for rectal cancer. It can guide the intraoperative improvement of lymph node dissection based on the preservation of LCA and peripheral autonomic nerves of IMA. This not only reduces the occurrence of postoperative complications and promotes rapid postoperative recovery, but also provides a more precise and individualized comprehensive treatment plan for patients after surgery. In addition，this trial also demonstrated that ICG is safe and feasible for use in rectal cancer

Detailed Description

The pathological data of 96 patients with rectal cancer from September 2020 - July 2022 were collected from the First Hospital of Qinhuangdao City.In 51 of these patients, ICG was injected preoperatively via anoscope or anal dilator in the mucosal layer around the tumor, and surgical treatment was performed after visualization. The surgical approach was performed by laparoscopic radical rectal cancer with an intermediate approach step.The IMA root is treated with low ligation of the IMA, while lymph node dissection is performed while preserving the autonomic nerves around the IMA. The other 45 patients were not injected with ICG, and the procedure was performed as before.The occurrence of postoperative complications was recorded, and the detection of lymph nodes was also compared between the two groups, as well as the intraoperative situation and postoperative recovery.

Conditions

Indocyanine Green

Study Design

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

Study Groups

non-ICG Group

Laparoscopic radical resection of rectal cancer was performed routinely without ICG injection

Group Type: PLACEBO_COMPARATOR

non-ICG

Intervention Type: OTHER

Laparoscopic radical resection of rectal cancer was performed routinely without ICG injection. The separation should extend from the center to the left, reaching the left paracolic sulcus lateral to the genital vessels. The Superior hypogastric nerve is protected by freeing it at the angle of the common iliac artery on both sides, afterwards, the vessel is free along the surface of the plexus from caudal to cephalic side to reach the root of the IMA. Switching lymph node visualization patterns. Based on the operator's experience and the extent of lymph node visualization, the lymph nodes at the root of the IMA were removed with an ultrasonic knife . The dissection continues caudally along the IMA, preserving the arterial sheath. Expose the left colonic artery, superior rectal artery, and sigmoid artery, maximum preservation of the IMA peripheral plexus while clearing their surrounding lymph nodes.

ICG Group

ICG was injected preoperatively via anoscope or anal dilator in the mucosal layer around the tumor, and surgical treatment was performed after visualization. The surgical approach was performed by laparoscopic radical rectal cancer with an intermediate approach step.The IMA root is treated with low ligation of the IMA, while lymph node dissection is performed while preserving the autonomic nerves around the IMA

Group Type: EXPERIMENTAL

ICG

Intervention Type: DRUG

Dilute ICG to 2.5 mg/ml with its accompanying sterilized water for injection. Slow injection with a 1ml syringe in 4 parts of the tumor，Inject 0.25ml per site . Procedure started after lymph node visualization.The operation was consistent with the control group.

Interventions

non-ICG

Laparoscopic radical resection of rectal cancer was performed routinely without ICG injection. The separation should extend from the center to the left, reaching the left paracolic sulcus lateral to the genital vessels. The Superior hypogastric nerve is protected by freeing it at the angle of the common iliac artery on both sides, afterwards, the vessel is free along the surface of the plexus from caudal to cephalic side to reach the root of the IMA. Switching lymph node visualization patterns. Based on the operator's experience and the extent of lymph node visualization, the lymph nodes at the root of the IMA were removed with an ultrasonic knife . The dissection continues caudally along the IMA, preserving the arterial sheath. Expose the left colonic artery, superior rectal artery, and sigmoid artery, maximum preservation of the IMA peripheral plexus while clearing their surrounding lymph nodes.

Intervention Type: OTHER

ICG

Dilute ICG to 2.5 mg/ml with its accompanying sterilized water for injection. Slow injection with a 1ml syringe in 4 parts of the tumor，Inject 0.25ml per site . Procedure started after lymph node visualization.The operation was consistent with the control group.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The preoperative colonoscopic pathological diagnosis was clearly rectal cancer and no malignant tumor in other sites.

2. Good preoperative general condition, no serious cardiopulmonary, hepatic, renal or other major comorbidities before surgery

3. Radical rectal cancer surgery with preservation of LCA and peripheral autonomic nerves of IMA in patients

4. No contraindications to surgery

5. No history of ICG or iodide allergy

Exclusion Criteria

-

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Hospital of Qinhuangdao

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

liuhanchong Hanchong Liu

Role: STUDY_CHAIR

The First Hospital of Qinhuangdao

Locations

The First hosptial of Qinhuangdao

Qinhuangdao, , China

Countries

China

Other Identifiers

20210130

Identifier Type: -

Identifier Source: org_study_id