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

Primary Purpose

Indocyanine Green

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
non-ICG
ICG
Sponsored by
The First Hospital of Qinhuangdao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Indocyanine Green focused on measuring Indocyanine Green, Rectal Cancer, Autonomic nerve, Inferior mesenteric artery, Left colic artery, lymph nodes

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • The First hosptial of Qinhuangdao

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

non-ICG Group

ICG Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
The total number of cleared lymph nodes
The sum of IMA root lymph nodes and lymph nodes surrounding the tumor area
The number of positive lymph nodes
There are metastatic tumor cells in the lymph nodes

Secondary Outcome Measures

Quality of postoperative recovery
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
mild or severe urogenital disorders, anastomotic leakage, anastomotic bleeding, abdominal infection, intestinal obstruction.

Full Information

First Posted
August 23, 2022
Last Updated
August 24, 2022
Sponsor
The First Hospital of Qinhuangdao
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1. Study Identification

Unique Protocol Identification Number
NCT05517681
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
July 10, 2022 (Actual)
Study Completion Date
July 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Qinhuangdao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indocyanine Green
Keywords
Indocyanine Green, Rectal Cancer, Autonomic nerve, Inferior mesenteric artery, Left colic artery, lymph nodes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-ICG Group
Arm Type
Placebo Comparator
Arm Description
Laparoscopic radical resection of rectal cancer was performed routinely without ICG injection
Arm Title
ICG Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
non-ICG
Intervention Description
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
Drug
Intervention Name(s)
ICG
Intervention Description
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 Outcome Measure Information:
Title
The number of cleared IMA root lymph nodes
Description
A group of lymph nodes surrounding the inferior mesenteric artery between the origin of the artery and the left colic artery
Time Frame
immediately after surgery
Title
The total number of cleared lymph nodes
Description
The sum of IMA root lymph nodes and lymph nodes surrounding the tumor area
Time Frame
immediately after surgery
Title
The number of positive lymph nodes
Description
There are metastatic tumor cells in the lymph nodes
Time Frame
immediately after surgery
Secondary Outcome Measure Information:
Title
Quality of postoperative recovery
Description
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
Time Frame
Up to 7 days after surgery
Title
The incidence of postoperative complications
Description
mild or severe urogenital disorders, anastomotic leakage, anastomotic bleeding, abdominal infection, intestinal obstruction.
Time Frame
Up to 7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
liuhanchong Hanchong Liu
Organizational Affiliation
The First Hospital of Qinhuangdao
Official's Role
Study Chair
Facility Information:
Facility Name
The First hosptial of Qinhuangdao
City
Qinhuangdao
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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