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

Not Applicable

Completed

• Conditions: Indocyanine Green
• Interventions: Other: non-ICG; Drug: ICG

• Registration Number: NCT05517681
• Lead Sponsor: The First Hospital of Qinhuangdao

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.

Study Timeline

• Study Start: 2020-09-07
• Primary Completion: 2022-07-10
• Study Completion: 2022-07-10
• Status Verified: 2022-08
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-24
• Last Update Submitted: 2022-08-24
• Study First Posted: 2022-08-26
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-ICG Group	non-ICG	Laparoscopic radical resection of rectal cancer was performed routinely without ICG injection
ICG Group	ICG	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

Primary Outcome Measures

Name	Time	Method
The number of cleared IMA root lymph nodes	immediately after surgery	A group of lymph nodes surrounding the inferior mesenteric artery between the origin of the artery and the left colic artery
The total number of cleared lymph nodes	immediately after surgery	The sum of IMA root lymph nodes and lymph nodes surrounding the tumor area
The number of positive lymph nodes	immediately after surgery	There are metastatic tumor cells in the lymph nodes

Secondary Outcome Measures

Name	Time	Method
Quality of postoperative recovery	Up to 7 days after surgery	days of postoperative hospitalization, days of retention of the urinary catheter, days of retention of abdominal drainage tube, time of first fluid intake and IPSS score
The incidence of postoperative complications	Up to 7 days after surgery	mild or severe urogenital disorders, anastomotic leakage, anastomotic bleeding, abdominal infection, intestinal obstruction.

Trial Locations

Locations (1)

The First hosptial of Qinhuangdao; 🇨🇳 Qinhuangdao, China