- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04008407
ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study (COVERT)
Endoscopic Submucosal Dissection for Sessile Polyps and Laterally Spreading Lesions of the Colorectum Using a Selective Strategy - a Prospective Cohort Study
Colonic Laterally spreading lesions (LSL) => 20mm are at high risk to progress to cancer. Overt stigmata of submucosal invasive cancer (SMIC) has been well characterized and includes ulceration and surface pit pattern changes as per the Kudo classification of type V.
In a recent report, risk factors for LSL with SMIC and no overt stigmata (i.e. covert SMIC) were described. Resection of these lesions 'en-bloc' can allow for better histological staging and potentially reduce the need for surgical resection.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
With over 14,000 patients diagnosed annually, colorectal carcinoma (CRC) is the second most frequently invasive malignancy in Australia. By not only diagnosing CRC at an early stage, but also removing precursor adenomas, colonoscopy with polypectomy reduces the risk of developing and dying from CRC.
Laterally spreading lesions >= 20mm (LSL) are more likely to progress to cancer. The prevalence of LSL ranges from 1-5% in screening population. The risk of malignant progression of colorectal adenomas found during colonoscopy increases with lesion size, i.e. the cancer preventive effect is likely to be maximal in large lesions. Patients with LSL have a higher risk of malignancy and a higher recurrence rate of adenoma after lesion removal compared with diminutive polyps.
Endoscopic imaging can now accurately predict LSL with submucosal invasive cancer (SMIC) through assessment of LSLs morphology (Paris classification, granularity) and surface pit-pattern (Kudo classification). Such cases can be considered to have LSL with overt risk of SMIC.
Recent publication has highlighted that some LSLs might hrbor SMIC without overt morphological features (i.e. high risk for covert SMIC). These LSL with high risk of covert SMIC stratified LSLs based on lesion location and lesion morphology.
Generally LSLs can be safely and effectively removed by wide field endoscopic mucosal resection (WF-EMR) in over 90% of cases in competent hands.
One of the draw backs with WF-EMR is it requires piecemeal resection and thus is limited in providing assessment of complete excision and depth of submucosal invasion in cases where SMIC is present.
Thus, endoscopic en-bloc resection is preferable from an oncologic standpoint to obtain a single specimen for proper histopathologic assessment. Endoscopic submucosal dissection (ESD) is a technique that is now becoming the preferred method for achieving a complete endoscopic and histologic resection, referred to as R0. Evidence from retrospective cohort and meta-analyses suggests ESD provides a more consistent oncologic resection with a reduced rate of recurrence. However, the major limitations with the technique relate to increased procedure time and the skill-set required for performing the procedure.
One of the other major limitations of ESD is significant cost associated with the procedure, which includes procedure time and additional equipment in addition to the treatment of any subsequent complications. As such the implementation of ESD as the standard of care for all colorectal lesions has not been undertaken in Western countries, however it may have an important role for selective cases especially where there is concern for sub-mucosal invasive cancer (SMIC).
The investigators propose a selective ESD strategy to be performed for patients focusing on overt evidence of SMIC and those at high risk of covert SMIC (defined as risk >10%). The investigators will follow a prospective cohort study assessing the use of selective ESD strategy in the colorectum in the Western population.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael J Bourke, Prof.
- Phone Number: +61288905555
- Email: endoscopyresearch.westmead@gmail.com
Study Contact Backup
- Name: Iddo Bar-Yishay, MD
- Phone Number: +61288905555
- Email: iddo.baryishay@health.nsw.gov.au
Study Locations
-
-
New South Wales
-
Westmead, New South Wales, Australia, 2145
- Recruiting
- Westmead Endoscopy Unit
-
Contact:
- Iddo Bar-Yishay, MD
- Phone Number: 88905555
- Email: iddo.baryishay@health.nsw.gov.au
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients referred for colorectal resection of large laterally spreading lesions in colon.
- Can give informed consent to trial participation
Exclusion Criteria:
- Previous resection or attempted resection of target adenoma lesion
- Endoscopic appearance of invasive malignancy
- Age less than 18 years
- Pregnancy
- Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
- Use of anticoagulant or antiplatelet agents other than aspirin outside of internationally recognised guidelines
- American Society of Anesthesiology (ASA) Grade IV-V
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ESD
Lesion with overt stigmata of SMIC or those with high risk (=> 10%) for covert SMIC.
|
Endoscopic Submucosal Dissection (ESD) results in en-bloc resection of LSL, regardless of lesion size.
This allows for accurate histopathological assessment of SMIC, R0/R1 resection and depth of invasion.
ESD is considered a potentially curative for superficial cancers (T1a).
Other Names:
|
Active Comparator: EMR
Lesion with no overt or a low risk for (<10%) for covert SMIC
|
EMR is the current standard for treating colonic LSL and has been validated to be safe and efficacious.
LSLs => 20mm are frequently resected piecemeal.
Recent research show that resection margin soft coagulation reduces recurrence rates to those similar to en-bloc resections.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of surgical referral
Time Frame: 3 months post procedure
|
Incidence of surgical referral due to non-curative endoscopic resection.
|
3 months post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
R0 resection rate
Time Frame: 3 months post procedure
|
Rate of en-bloc resection with clear resection margins.
|
3 months post procedure
|
En Bloc resection rate
Time Frame: 3 months post procedure
|
Rate of en-bloc resection
|
3 months post procedure
|
Technical success rate
Time Frame: 3 months post procedure
|
Rate of procedures completed as per protocol
|
3 months post procedure
|
Duration of procedure
Time Frame: procedure
|
Procedure duration in minutes.
|
procedure
|
Adenoma recurrence rate
Time Frame: 3 years post procedure
|
Rate of recurrent adenoma at resection site on follow-up.
|
3 years post procedure
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
- Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8.
- Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
- Iishi H, Tatsuta M, Iseki K, Narahara H, Uedo N, Sakai N, Ishikawa H, Otani T, Ishiguro S. Endoscopic piecemeal resection with submucosal saline injection of large sessile colorectal polyps. Gastrointest Endosc. 2000 Jun;51(6):697-700. doi: 10.1067/mge.2000.104652.
- Risio M. The natural history of colorectal adenomas and early cancer. Pathologe. 2012 Nov;33 Suppl 2:206-10. doi: 10.1007/s00292-012-1640-6.
- Nanda KS, Tutticci N, Burgess NG, Sonson R, Williams SJ, Bourke MJ. Endoscopic mucosal resection of laterally spreading lesions involving the ileocecal valve: technique, risk factors for failure, and outcomes. Endoscopy. 2015 Aug;47(8):710-8. doi: 10.1055/s-0034-1391732. Epub 2015 Mar 12.
- Oka S, Tanaka S, Saito Y, Iishi H, Kudo SE, Ikematsu H, Igarashi M, Saitoh Y, Inoue Y, Kobayashi K, Hisabe T, Tsuruta O, Sano Y, Yamano H, Shimizu S, Yahagi N, Watanabe T, Nakamura H, Fujii T, Ishikawa H, Sugihara K; Colorectal Endoscopic Resection Standardization Implementation Working Group of the Japanese Society for Cancer of the Colon and Rectum, Tokyo, Japan. Local recurrence after endoscopic resection for large colorectal neoplasia: a multicenter prospective study in Japan. Am J Gastroenterol. 2015 May;110(5):697-707. doi: 10.1038/ajg.2015.96. Epub 2015 Apr 7.
- Lee EJ, Lee JB, Lee SH, Youk EG. Endoscopic treatment of large colorectal tumors: comparison of endoscopic mucosal resection, endoscopic mucosal resection-precutting, and endoscopic submucosal dissection. Surg Endosc. 2012 Aug;26(8):2220-30. doi: 10.1007/s00464-012-2164-0. Epub 2012 Jan 26.
- Terasaki M, Tanaka S, Oka S, Nakadoi K, Takata S, Kanao H, Yoshida S, Chayama K. Clinical outcomes of endoscopic submucosal dissection and endoscopic mucosal resection for laterally spreading tumors larger than 20 mm. J Gastroenterol Hepatol. 2012 Apr;27(4):734-40. doi: 10.1111/j.1440-1746.2011.06977.x.
- Burgess NG, Hourigan LF, Zanati SA, Brown GJ, Singh R, Williams SJ, Raftopoulos SC, Ormonde D, Moss A, Byth K, Mahajan H, McLeod D, Bourke MJ. Risk Stratification for Covert Invasive Cancer Among Patients Referred for Colonic Endoscopic Mucosal Resection: A Large Multicenter Cohort. Gastroenterology. 2017 Sep;153(3):732-742.e1. doi: 10.1053/j.gastro.2017.05.047. Epub 2017 Jun 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU RED HREC/17/WMEAD/497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Neoplasm
-
Azienda Ospedaliera di PadovaIstituto Oncologico Veneto IRCCSRecruitingColorectal Adenocarcinoma | Colorectal Liver Metastases | Unresectable Malignant NeoplasmItaly
-
Carol Davila University of Medicine and PharmacyRecruitingNeoplasm, Colorectal | Neoplasm, Stomach | Neoplasm, Esophagus | Neoplasm, DuodenalRomania
-
Koen RoversHoffmann-La Roche; Comprehensive Cancer Centre The Netherlands; Dutch Cancer...RecruitingColorectal Cancer | Peritoneal Neoplasms | Colorectal Neoplasm | Peritoneal Carcinomatosis | Colorectal Carcinoma | Peritoneal Cancer | Peritoneal Metastases | Colorectal Adenocarcinoma | Colorectal Neoplasms Malignant | Peritoneal Neoplasm Malignant Secondary Carcinomatosis | Peritoneal Neoplasm Malignant...Netherlands, Belgium
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingMetastatic Malignant Neoplasm in the Liver | Advanced Malignant Neoplasm | Refractory Malignant Neoplasm | Colorectal Carcinoma Metastatic in the LiverUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Recurrent Colorectal Carcinoma | Metastatic Malignant Neoplasm in the Liver | Metastatic Colorectal Carcinoma | Metastatic Malignant Neoplasm in the Lung | Resectable Colorectal CarcinomaUnited States
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityUnknownColorectal Cancer | Neoplasm | Metastatic NeoplasmChina
-
Fundació Institut de Recerca de l'Hospital de la...UnknownColorectal Cancer | AngiogenesisSpain
-
TransgeneTerminatedColorectal Neoplasm | Digestive System NeoplasmFrance, Spain, Belgium
-
Mayo ClinicRecruitingColorectal Cancer | Colorectal Liver MetastasesUnited States
-
Bristol-Myers SquibbNovartisActive, not recruitingColorectal Cancer | Colorectal Neoplasm | Colorectal Tumors | Colorectal CarcinomaItaly, United States, Canada, Spain, Argentina, Australia, Belgium, Chile, Czechia, Germany
Clinical Trials on Endoscopic Submucosal Dissection
-
Chinese PLA General HospitalUnknown
-
Portsmouth Hospitals NHS TrustRecruitingEndoscopic Submucosal DissectionUnited Kingdom
-
Central Hospital, Nancy, FranceActive, not recruitingColorectal Neoplasms | Perforation Colon | Perforation of RectumFrance, Belgium
-
Soonchunhyang University HospitalCompletedEarly Gastric Cancer | Gastric DysplasiaKorea, Republic of
-
National Evidence-Based Healthcare Collaborating...UnknownEarly Gastric Cancer | Endoscopic Submucosal Dissection | Multi-center, Single-arm Clinical Trial | Historical Control Group | Quality of Life and Cost AnalysisKorea, Republic of
-
AdventHealthRecruitingBarrett Esophagus | Esophageal Lesion | Gastrointestinal LesionsUnited States
-
Assistance Publique - Hôpitaux de ParisCompletedColorectal Neoplasms | Endoscopic Submucosal DissectionFrance
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Central Hospital, Nancy, FranceCompleted
-
Hôpital Edouard HerriotCompleted