Assessment of Autologous Blood Marker Localization in Laparoscopic Colorectal Cancer Surgery
ABILITY
1 other identifier
interventional
220
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2022
CompletedFirst Posted
Study publicly available on registry
October 28, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedMarch 8, 2023
March 1, 2023
1.5 years
October 23, 2022
March 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Autogenous blood marker localization was not inferior to intraoperative colonoscopy localization
While checking the intraperitoneal cavity at the start of the surgery, the visibility of tattooing will be first checked. After the complete resection of the colon segment, resected colon specimen will be checked the localization with autologous blood tattooing. The localization accuracy of autologous blood marker will be similar to that of intraoperative colonoscopy localization.
From the beginning of endoscopic tattooing to the end of the surgery.
Secondary Outcomes (1)
Adverse events related to endoscopic tattooing
From the beginning of colonoscopic tattooing to 2 weeks after surgery.
Study Arms (2)
Autologous Blood Marker Group
EXPERIMENTALThe tattooing was performed at 24-48 hours before the surgery. When the lesion was identified by endoscopy, 2-3 ml of the patient's peripheral venous blood without heparin preparation were injected submucosally at the distal side and proximal side of the lesion using a conventional endoscopic needle without submucosal injection of normal saline.
Intraoperative colonoscopy group
ACTIVE COMPARATORUnder general anesthesia with endotracheal intubation, the patient was placed in the modified lithotomy position. After routine laparoscopic exploration, CO2-insufflated intraoperative colonoscopy was performed using a flexible videocolonoscope. Upstream small bowel clamping was applied before intraoperative colonoscopy. During intraoperative colonoscopy, CO2 pneumoperitoneum was maintained by the insufflator so that the laparoscope could guide the colonoscope effectively.
Interventions
This is one of the routine procedures used for colorectal cancer resection.
Eligibility Criteria
You may qualify if:
- Age from 18 to 80 years
- Large lateral spreading tumors that could not be treated endoscopically, serosa-negative malignant colorectal tumors (≤ cT3), and malignant polyps treated endoscopically that required additional colorectal resection.
- The tumor is located in the colon, middle and high rectum (the lower margin of the tumor does not exceed peritoneal reflexes)
- No distant metastasis.
- American Society of Anesthesiology score (ASA) class I-III
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- Written informed consent
You may not qualify if:
- BMI \> 35kg/m2
- Previous history of gastrointestinal surgery that altered the gastrointestinal anatomy.
- Pregnant or lactating women
- Severe mental disorder
- History of previous abdominal surgery (except cholecystectomy and appendectomy) Rejection of laparoscopic resection
- History of cerebrovascular accident within the past six months
- History of unstable angina or myocardial infarction within the past six months
- History of previous neoadjuvant chemotherapy or radiotherapy
- Comorbidity of emergent conditions like obstruction, bleeding or perforation.
- Needing simultaneous surgery for other diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123, China
Related Publications (1)
Zhang KH, Li JZ, Zhang HB, Hu RH, Cui XM, Du T, Zheng L, Zhang S, Song C, Xu MD, Jiang XH. Assessment of Autologous Blood marker localIzation and intraoperative coLonoscopy localIzation in laparoscopic colorecTal cancer surgery (ABILITY): a randomized controlled trial. BMC Cancer. 2023 Mar 3;23(1):204. doi: 10.1186/s12885-023-10669-w.
PMID: 36869328DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2022
First Posted
October 28, 2022
Study Start
November 1, 2022
Primary Completion
April 30, 2024
Study Completion
June 30, 2024
Last Updated
March 8, 2023
Record last verified: 2023-03