Rectal CancerNCT04016948
Optical Biopsy for Distal Margin in Low Rectal Cancer
A study testing Probe-based confocal laser endomicroscopy optical biopsy and Intra-operative frozen section in people with Rectal Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This is a multi-center prospective randomized controlled study. In this study, the investigators will use confocal laser endomicroscopy to make real-time in vivo optical biopsy of distal margin in rectal cancer surgery and help surgeons to make surgical decision.The investigators also assess the accuracy of CLE… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Probe-based confocal laser endomicroscopy optical biopsy and Intra-operative frozen section
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2017to 1 May 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages from 18 to 70 years.
- Rectal tumor confirmed pathologically by endoscopic biopsy.
- The distance from lower edge of tumor to the dentate line is less than 5cm.
- Plan to perform curative resection.
- ASA(American Society of Anesthesiology)score class I,II,or III.
- Able to provide written informed consent.
Who cannot join
- Intestinal perforation or acute intestinal obstruction.
- Multiple distant metastasis and can not R0 resection.
- T4b according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
- Pregnancy or breastfeeding.
- Impaired renal function
- American Society of Anesthesiology score (ASA) class IV or V.
- Unable or refuse to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515
About this study
Official title: A Multicenter Randomized Study of Real-time In-vivo Confocal Laser Endomicroscopy Optical Biopsy for Distal Margin in Low Rectal Cancer Compared to Intraoperative Frozen Section
This is a multi-center prospective randomized controlled study. In this study, the investigators will use confocal laser endomicroscopy to make real-time in vivo optical biopsy of distal margin in rectal cancer surgery and help surgeons to make surgical decision.The investigators also assess the accuracy of CLE optical biopsy, compared with intra-operative frozen section.
Read the detailed description
In low rectal cancer surgery, how to select the precise dissection plane and optimal surgical procedure is an important challenge for surgeons. In current clinic, surgeons select dissection plane by a comprehensive judgment of pre-operative pelvis MRI, colonoscopy and digital rectal examination, then through submitting the "doughnut" after cutting and anastomosis to intra-operative frozen section (IFS) to definite whether there is residual tumor in distal margin (DM). However, IFS can only make diagnosis using the tissue specimen in vitro and time-consuming. Once the IFS confirm positive margin, it always means anal resection should be implemented to ensure radical treatment. Therefore, if there is a real-time in situ examination method to evaluate DM in vivo, it will bring great benefits to both surgeons and patients.
Confocal laser endomicroscopy (CLE) had been widely used in medical field to diagnose colorectal disease, but it is seldom applied in surgical filed especially in rectal cancer to make optical biopsy and help surgical decision-making. Therefore, the investigators hypothesize that CLE can real-time in situ evaluate DM during surgery in rectal cancer and its accuracy is non-inferior to intra-operative frozen section.
In this study, the investigators will randomly assign patients to the experimental group (CLE optical biopsy) and control group (IFS). Using H-E staining pathological diagnosis as golden standard, the accuracy, sensitivity and specificity of both CLE optical biopsy and IFS will be evaluated and compared. And the investigators will also evaluate patients' postoperative urinary function, defection function and quality of life through a year follow-up.
- Conditions
- Rectal Cancer
- Being tested
- Probe-based confocal laser endomicroscopy optical biopsy, Intra-operative frozen section
- Keywords
- Rectal cancer, distal margin, confocal laser endomicroscopy, real-time, in vivo, optical biopsy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probe-based confocal laser endomicroscopy optical biopsyDevice
In the pCLE group, after intravenous injection of fluorescein, the optical biopsy will be performed, using a confocal miniprobe, to exam the rectal mucosa when the rectum transection is ready. The raters will analyse the CLE images to determine whether the distal margin is positive. In the IFS group, intra-operative frozen section will be performed at the site of distal margin after the rectum transection.
Intra-operative frozen sectionDevice
In the pCLE group, after intravenous injection of fluorescein, the optical biopsy will be performed, using a confocal miniprobe, to exam the rectal mucosa when the rectum transection is ready. The raters will analyse the CLE images to determine whether the distal margin is positive. In the IFS group, intra-operative frozen section will be performed at the site of distal margin after the rectum transection.
| Study group | Role | What they receive |
|---|---|---|
| Probe-based confocal laser endomicroscopy(pCLE) | Experimental | Confocal laser endomicroscopy optical biopsy will be performed in surgery for patients assigned to this group Receives: Device: Probe-based confocal laser endomicroscopy optical biopsy |
| Intra-operative frozen section(IFS) | Active comparator | Intra-operative frozen section will be performed for patients assigned to this group Receives: Device: Intra-operative frozen section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of optical biopsy
Accuracy of confocal laser endomicroscopy optical biopsy of distal margin is determined by the pathology result.
Measured: One week after surgery
Secondary outcomes (3)
Sensitivity and Specificity
Sensitivity and specificity of confocal laser endomicroscopy optical biopsy of distal margin are determined by the pathology result.
Measured: One week after surgery
Operation related indexes
Operation time in minutes
Measured: One week after surgery
Postoperative function recovery
Defecation and sphincter function will be combined to report Wexner score.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start28 Jun 2017
- Primary completion1 Sep 2020 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Medical University, China, Shenzhen Hospital of Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Jun Yan, M.D., Ph.D, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016948
- Sponsor's protocol ID
- yanjun
- Status last verified
- Jul 2019
- First submitted
- 26 Jul 2017
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rullier E, Laurent C, Bretagnol F, Rullier A, Vendrely V, Zerbib F. Sphincter-saving resection for all rectal carcinomas: the end of the 2-cm distal rule. Ann Surg. 2005 Mar;241(3):465-9. doi: 10.1097/01.sla.0000154551.06768.e1.
PubMed 15729069Gomes RM, Bhandare M, Desouza A, Bal M, Saklani AP. Role of intraoperative frozen section for assessing distal resection margin after anterior resection. Int J Colorectal Dis. 2015 Aug;30(8):1081-9. doi: 10.1007/s00384-015-2244-4. Epub 2015 May 16.
PubMed 25982468Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. doi: 10.1016/j.cgh.2006.05.010. Epub 2006 Jul 13.
PubMed 16843068Pech O, Rabenstein T, Manner H, Petrone MC, Pohl J, Vieth M, Stolte M, Ell C. Confocal laser endomicroscopy for in vivo diagnosis of early squamous cell carcinoma in the esophagus. Clin Gastroenterol Hepatol. 2008 Jan;6(1):89-94. doi: 10.1016/j.cgh.2007.10.013. Epub 2007 Dec 11.
PubMed 18063417Li Z, Zuo XL, Yu T, Gu XM, Zhou CJ, Li CQ, Ji R, Li YQ. Confocal laser endomicroscopy for in vivo detection of gastric intestinal metaplasia: a randomized controlled trial. Endoscopy. 2014 Apr;46(4):282-90. doi: 10.1055/s-0033-1359215. Epub 2014 Jan 28.
PubMed 24473908Li WB, Zuo XL, Li CQ, Zuo F, Gu XM, Yu T, Chu CL, Zhang TG, Li YQ. Diagnostic value of confocal laser endomicroscopy for gastric superficial cancerous lesions. Gut. 2011 Mar;60(3):299-306. doi: 10.1136/gut.2010.223586. Epub 2010 Dec 30.
PubMed 21193460Xie XJ, Li CQ, Zuo XL, Yu T, Gu XM, Li Z, Ji R, Wang Q, Li YQ. Differentiation of colonic polyps by confocal laser endomicroscopy. Endoscopy. 2011 Feb;43(2):87-93. doi: 10.1055/s-0030-1255919. Epub 2010 Oct 29.
PubMed 21038291Tan J, Ji HL, Hu YW, Li ZM, Zhuang BX, Deng HJ, Wang YN, Zheng JX, Jiang W, Yan J. Real-time in vivo distal margin selection using confocal laser endomicroscopy in transanal total mesorectal excision for rectal cancer. World J Gastrointest Surg. 2022 Dec 27;14(12):1375-1386. doi: 10.4240/wjgs.v14.i12.1375.
PubMed 36632126
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Study of Real-time In-vivo Confocal Laser Endomicroscopy Optical Biopsy for Distal Margin in Low Rectal Cancer Compared to Intraoperative Frozen Section
- ClinicalTrials.gov ID
- NCT04016948
- Acronym / sponsor ID
- yanjun
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, distal margin, confocal laser endomicroscopy, real-time, in vivo, optical biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Southern Medical University, China, Shenzhen Hospital of Southern Medical University
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 12 Jul 2019 (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.
This is a multi-center prospective randomized controlled study. In this study, the investigators will use confocal laser endomicroscopy to make real-time in vivo optical biopsy of distal margin in rectal cancer surgery and help surgeons to make surgical decision.The investigators also assess the accuracy of CLE optical biopsy, compared with intra-operative frozen section.
Detailed description
In low rectal cancer surgery, how to select the precise dissection plane and optimal surgical procedure is an important challenge for surgeons. In current clinic, surgeons select dissection plane by a comprehensive judgment of pre-operative pelvis MRI, colonoscopy and digital rectal examination, then through submitting the "doughnut" after cutting and anastomosis to intra-operative frozen section (IFS) to definite whether there is residual tumor in distal margin (DM). However, IFS can only make diagnosis using the tissue specimen in vitro and time-consuming. Once the IFS confirm positive margin, it always means anal resection should be implemented to ensure radical treatment. Therefore, if there is a real-time in situ examination method to evaluate DM in vivo, it will bring great benefits to both surgeons and patients.
Confocal laser endomicroscopy (CLE) had been widely used in medical field to diagnose colorectal disease, but it is seldom applied in surgical filed especially in rectal cancer to make optical biopsy and help surgical decision-making. Therefore, the investigators hypothesize that CLE can real-time in situ evaluate DM during surgery in rectal cancer and its accuracy is non-inferior to intra-operative frozen section.
In this study, the investigators will randomly assign patients to the experimental group (CLE optical biopsy) and control group (IFS). Using H-E staining pathological diagnosis as golden standard, the accuracy, sensitivity and specificity of both CLE optical biopsy and IFS will be evaluated and compared. And the investigators will also evaluate patients' postoperative urinary function, defection function and quality of life through a year follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probe-based confocal laser endomicroscopy(pCLE) | Experimental | Device: Probe-based confocal laser endomicroscopy optical biopsyConfocal laser endomicroscopy optical biopsy will be performed in surgery for patients assigned to this group |
| Intra-operative frozen section(IFS) | Active comparator | Device: Intra-operative frozen sectionIntra-operative frozen section will be performed for patients assigned to this group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages from 18 to 70 years.
- Rectal tumor confirmed pathologically by endoscopic biopsy.
- The distance from lower edge of tumor to the dentate line is less than 5cm.
- Plan to perform curative resection.
- ASA(American Society of Anesthesiology)score class I,II,or III.
Key exclusion criteria (7 listed)
- Intestinal perforation or acute intestinal obstruction.
- Multiple distant metastasis and can not R0 resection.
- T4b according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
- Pregnancy or breastfeeding.
- Impaired renal function
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 |
|---|---|---|
| Probe-based confocal laser endomicroscopy optical biopsyIn the pCLE group, after intravenous injection of fluorescein, the optical biopsy will be performed, using a confocal miniprobe, to exam the rectal mucosa when the rectum transection is ready. The raters will analyse the CLE images to determine whether the distal margin is positive. In the IFS group, intra-operative frozen section will be performed at the site of distal margin after the rectum transection. | Device | Probe-based confocal laser endomicroscopy(pCLE) |
| Intra-operative frozen sectionIn the pCLE group, after intravenous injection of fluorescein, the optical biopsy will be performed, using a confocal miniprobe, to exam the rectal mucosa when the rectum transection is ready. The raters will analyse the CLE images to determine whether the distal margin is positive. In the IFS group, intra-operative frozen section will be performed at the site of distal margin after the rectum transection. | Device | Intra-operative frozen section(IFS) |
Primary outcome
Accuracy of optical biopsy
Time frame: One week after surgery
Accuracy of confocal laser endomicroscopy optical biopsy of distal margin is determined by the pathology result.
3 secondary outcomes
Sensitivity and Specificity
Time frame: One week after surgery
Operation related indexes
Time frame: One week after surgery
Postoperative function recovery
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Background: PubMed 15729069Rullier E, Laurent C, Bretagnol F, Rullier A, Vendrely V, Zerbib F. Sphincter-saving resection for all rectal carcinomas: the end of the 2-cm distal rule. Ann Surg. 2005 Mar;241(3):465-9. doi: 10.1097/01.sla.0000154551.06768.e1.
- Background: PubMed 25982468Gomes RM, Bhandare M, Desouza A, Bal M, Saklani AP. Role of intraoperative frozen section for assessing distal resection margin after anterior resection. Int J Colorectal Dis. 2015 Aug;30(8):1081-9. doi: 10.1007/s00384-015-2244-4. Epub 2015 May 16.
- Background: PubMed 16843068Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. doi: 10.1016/j.cgh.2006.05.010. Epub 2006 Jul 13.
- Background: PubMed 18063417Pech O, Rabenstein T, Manner H, Petrone MC, Pohl J, Vieth M, Stolte M, Ell C. Confocal laser endomicroscopy for in vivo diagnosis of early squamous cell carcinoma in the esophagus. Clin Gastroenterol Hepatol. 2008 Jan;6(1):89-94. doi: 10.1016/j.cgh.2007.10.013. Epub 2007 Dec 11.
- Background: PubMed 24473908Li Z, Zuo XL, Yu T, Gu XM, Zhou CJ, Li CQ, Ji R, Li YQ. Confocal laser endomicroscopy for in vivo detection of gastric intestinal metaplasia: a randomized controlled trial. Endoscopy. 2014 Apr;46(4):282-90. doi: 10.1055/s-0033-1359215. Epub 2014 Jan 28.
- Background: PubMed 21193460Li WB, Zuo XL, Li CQ, Zuo F, Gu XM, Yu T, Chu CL, Zhang TG, Li YQ. Diagnostic value of confocal laser endomicroscopy for gastric superficial cancerous lesions. Gut. 2011 Mar;60(3):299-306. doi: 10.1136/gut.2010.223586. Epub 2010 Dec 30.
- Background: PubMed 21038291Xie XJ, Li CQ, Zuo XL, Yu T, Gu XM, Li Z, Ji R, Wang Q, Li YQ. Differentiation of colonic polyps by confocal laser endomicroscopy. Endoscopy. 2011 Feb;43(2):87-93. doi: 10.1055/s-0030-1255919. Epub 2010 Oct 29.
- Derived from this study: PubMed 36632126Tan J, Ji HL, Hu YW, Li ZM, Zhuang BX, Deng HJ, Wang YN, Zheng JX, Jiang W, Yan J. Real-time in vivo distal margin selection using confocal laser endomicroscopy in transanal total mesorectal excision for rectal cancer. World J Gastrointest Surg. 2022 Dec 27;14(12):1375-1386. doi: 10.4240/wjgs.v14.i12.1375.
- Individual participant dataSharing planned: No
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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.
Jun Yan, M.D., Ph.D principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probe-based confocal laser endomicroscopy optical biopsy and Intra-operative frozen section in people with Rectal Cancer, run by Nanfang Hospital, Southern Medical University 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 6 inclusion and 7 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 12 Jul 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of optical biopsy (time frame: One week after 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 NCT04016948, which also lists 8 linked publications.
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 12 Jul 2019.