NCT05597384

Assessment of Autologous Blood Marker Localization in Laparoscopic Colorectal Cancer Surgery

Assessment of Autologous Blood Marker Localization and Intraoperative Colonoscopy Localization in Laparoscopic Colorectal Cancer Surgery: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Laparoscopic colorectal surgery has been proved to have similar oncological outcomes with open surgery. Due to the lack of tactile perception, surgeons may have misjudgments in laparoscopic colorectal surgery. Therefore, the accurate localization of a tumor before surgery is important, especially in the early stages of cancer. Recently, some retrospective studies reported the use of patients' autologous blood for preoperative colonic localization in colorectal cancer with successful detection by laparoscopy, but its benefits remain controversial. This study aimed to assess the accuracy and safety of autogenous blood marker localization in laparoscopic radical resection for colorectal cancer.

Detailed description

Laparoscopic surgery has become the standard for management of colorectal cancer(CRC) with the advantages of less traumatic procedure, but similar oncological outcomes to open surgery. Due to the lack of tactile perception (haptic feedback), surgeons may have misjudgments in patients with small or flat early colon cancer, malignant polyps resected by endoscopic mucosal resection or endoscopic submucosal dissection. Therefore, the accurate localization of a tumor before surgery is important, especially in the early stages of cancer, to clarify the extent of surgical resection. Several methods are currently being proposed and used to identify the location of tumors. These include endoscopic tattooing with India ink, indocyanine green (ICG), preoperative endoscopic metal clipping with detection using an x-ray or palpation during surgery, and intraoperative endoscopy. Recently, some retrospective studies reported the use of patients' autologous blood for preoperative colonic localization in CRC with successful detection by laparoscopy. Autologous blood was thought a feasible and safe tattooing agent for preoperative endoscopic localization. Nonetheless, all currently available evidence comes from observational studies that are susceptible to bias. We therefore proposed to conduct this randomized controlled clinical trial to evaluate the accuracy and safety of autogenous blood marker localization in laparoscopic radical resection for colorectal cancer.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic colorectal cancer resection	This is one of the routine procedures used for colorectal cancer resection.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-04-30
• Completion: 2024-06-30
• First posted: 2022-10-28
• Last updated: 2023-03-08

Locations

1 site across 1 country: China