Clinical trial NCT05517681: Application of ICG in Lymph Node Dissection During Radical Resection of Rectal Cancer With Preserved Autonomic Nerves Around LCA and IMA
Official title: Application of ICG in Lymph Node Dissection During Radical Resection of Rectal Cancer With Preserved Autonomic Nerves Around LCA and IMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indocyanine Green
Keywords: Indocyanine Green
Rectal Cancer
Autonomic nerve
Inferior mesenteric artery
Left colic artery
lymph nodes
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2022-08-26
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

-

Primary outcomes:
measure: The number of cleared IMA root lymph nodes
timeFrame: immediately after surgery
measure: The total number of cleared lymph nodes
timeFrame: immediately after surgery
measure: The number of positive lymph nodes
timeFrame: immediately after surgery
Secondary outcomes:
measure: Quality of postoperative recovery
timeFrame: Up to 7 days after surgery
measure: The incidence of postoperative complications
timeFrame: Up to 7 days after surgery
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: The First hosptial of Qinhuangdao
Study officials:
affiliation: The First Hospital of Qinhuangdao
name: liuhanchong Hanchong Liu
role: STUDY_CHAIR
References: