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Completed

NCT Number: NCT05517681

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

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

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Key information

Conditions

Indocyanine Green Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First hosptial of Qinhuangdao

Qinhuangdao, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

-

Treatment and study plan

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.

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.

Primary outcomes

  1. The number of cleared IMA root lymph nodes

    Time frame: immediately after surgery

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

  2. The total number of cleared lymph nodes

    Time frame: immediately after surgery

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

  3. The number of positive lymph nodes

    Time frame: immediately after surgery

    There are metastatic tumor cells in the lymph nodes

Secondary outcomes

  1. Quality of postoperative recovery

    Time frame: 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

  2. The incidence of postoperative complications

    Time frame: Up to 7 days after surgery

    mild or severe urogenital disorders, anastomotic leakage, anastomotic bleeding, abdominal infection, intestinal obstruction.

Sponsors and collaborators

Lead sponsor

The First Hospital of Qinhuangdao

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2022
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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