Colorectal CancerABILITYNCT05597384
Assessment of Autologous Blood Marker Localization in Laparoscopic Colorectal Cancer Surgery
A study testing Laparoscopic colorectal cancer resection in people with Colorectal Cancer, run by Shanghai East Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Laparoscopic colorectal cancer resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Xiaohua Jiang, MD
Shun Zhang, MD
About this study
Official title: Assessment of Autologous Blood Marker Localization and Intraoperative Colonoscopy Localization in Laparoscopic Colorectal Cancer Surgery: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Laparoscopic colorectal cancer resection
- Keywords
- Colorectal cancer, Autologous blood, Endoscopy tattooing, Preoperative localization
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic colorectal cancer resectionProcedure or surgery
This is one of the routine procedures used for colorectal cancer resection.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Blood Marker Group | Experimental | The 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. Receives: Procedure: Laparoscopic colorectal cancer resection |
| Intraoperative colonoscopy group | Active comparator | Under 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. Receives: Procedure: Laparoscopic colorectal cancer resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the beginning of endoscopic tattooing to the end of the surgery.
Secondary outcomes (1)
Adverse events related to endoscopic tattooing
The secondary endpoint is the localization safety. Adverse events related to endoscopic tattooing, such as perforation, abscess formation, peritonitis, post-tattoo fever, post-tattoo abdominal pain, and intraperitoneal spillage of tattooing agent, were evaluated in autologous blood group.
Measured: From the beginning of colonoscopic tattooing to 2 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Nov 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597384
- Sponsor's protocol ID
- Shanghaieasthospital-2022113
- Acronym
- ABILITY
- Status last verified
- Mar 2023
- First submitted
- 23 Oct 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36869328
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Autologous Blood Marker Localization and Intraoperative Colonoscopy Localization in Laparoscopic Colorectal Cancer Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05597384
- Acronym / sponsor ID
- ABILITY / Shanghaieasthospital-2022113
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Autologous blood, Endoscopy tattooing, Preoperative localization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Blood Marker Group | Experimental | Procedure: Laparoscopic colorectal cancer resectionThe 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 comparator | Procedure: Laparoscopic colorectal cancer resectionUnder 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic colorectal cancer resectionThis is one of the routine procedures used for colorectal cancer resection. | Procedure or surgery | Autologous Blood Marker Group, Intraoperative colonoscopy group |
Primary outcome
Autogenous blood marker localization was not inferior to intraoperative colonoscopy localization
Time frame: From the beginning of endoscopic tattooing to the end of the surgery.
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.
1 secondary outcome
Adverse events related to endoscopic tattooing
Time frame: From the beginning of colonoscopic tattooing to 2 weeks after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 36869328Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic colorectal cancer resection in people with Colorectal Cancer, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-hua Jiang, MD ((8621)38804518, jiangxiaohuash@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autogenous blood marker localization was not inferior to intraoperative colonoscopy localization (time frame: From the beginning of endoscopic tattooing to the end of the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.