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

NCT05517681 | Completed

• 1 other identifier: 20210130
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Indocyanine Green

Keywords

Indocyanine Green; Rectal Cancer; Autonomic nerve; Inferior mesenteric artery; Left colic artery; lymph nodes

Outcome Measures

Primary Outcomes (3)

• The number of cleared IMA root lymph nodes

  A group of lymph nodes surrounding the inferior mesenteric artery between the origin of the artery and the left colic artery

  immediately after surgery

• The total number of cleared lymph nodes

  The sum of IMA root lymph nodes and lymph nodes surrounding the tumor area

  immediately after surgery

• The number of positive lymph nodes

  There are metastatic tumor cells in the lymph nodes

  immediately after surgery

Secondary Outcomes (2)

• Quality of postoperative recovery

  Up to 7 days after surgery

• The incidence of postoperative complications

  Up to 7 days after surgery

Study Arms (2)

non-ICG Group

PLACEBO COMPARATOR

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

Other: non-ICG

ICG Group

EXPERIMENTAL

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

Drug: ICG

Interventions

non-ICG 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.

non-ICG Group

ICG 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.

ICG Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The preoperative colonoscopic pathological diagnosis was clearly rectal cancer and no malignant tumor in other sites.
• Good preoperative general condition, no serious cardiopulmonary, hepatic, renal or other major comorbidities before surgery
• Radical rectal cancer surgery with preservation of LCA and peripheral autonomic nerves of IMA in patients
• No contraindications to surgery
• No history of ICG or iodide allergy

Sponsors & Collaborators

• The First Hospital of Qinhuangdao: lead

Study Sites (1)

The First hosptial of Qinhuangdao

Qinhuangdao, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• liuhanchong Hanchong Liu

  The First Hospital of Qinhuangdao

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 26, 2022
• Study Start: September 7, 2020
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)