Sentinel Lymph Node Biopsy in Rectal Cancer

NANot yet recruitingINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

May 31, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Rectal Cancer Stage IIIRectal Cancer Stage IV
Interventions
PROCEDURE

Sentinel lymph node biopsy

After the total mesorectal excision, the indocyanine green was injected around the tumor via the anus. The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed and sent for rapid frozen pathological examination. Subsequently, a lateral lymph node dissection was performed.

DRUG

Indocyanine green solution

Indocyanine green was injected around the tumor via the anus to visualize the sentinel lymph nodes under the fluorescence laparoscope.

DEVICE

fluorescence laparoscope

The fluorescence laparoscope was used to visualize and locate the sentinel lymph node.

DIAGNOSTIC_TEST

pathological examination

The surgical specimens and sentinel lymph nodes were routinely examined for pathology.

DIAGNOSTIC_TEST

rapid frozen pathological examination

The lateral green fluorescence imaging sentinel lymph nodes found during surgery was sent to make cryosections. And then a pathologist makes a rapid diagnosis under a microscope。

PROCEDURE

total mesorectal excision

"1. Sharply dissect the vascular interface between the pelvic fascia parietal layer and the visceral layer around the mesentery under direct vision to ensure that the rectal mesentery of the resected specimen is intact and tearless.~2. For medium and low rectal cancer: the distal intestinal tube of the tumor should be resected ≥ 2 cm.~3. TME or mesenteric distal resection margin ≥ 5 cm away from the tumor."

Trial Locations (1)

100000

National Cancer Center, Beijing

All Listed Sponsors
lead

National Cancer Center, China

OTHER

NCT05830890 - Sentinel Lymph Node Biopsy in Rectal Cancer | Biotech Hunter | Biotech Hunter