The aim of this study is to investigate the safety and efficacy of CAL-WR as primary and curative colon-preserving treatment for T1 colon cancer. Our primary endpoint is reduction of oncologic resections for low-risk T1 colon cancer. As secondary…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
- Surigical procedure
N.a.
Outcome measures
Primary outcome
<p>Reduction of oncologic resections for low-risk T1 colon carcinomas by using<br />
CAL-WR as primary treatment. </p>
Secondary outcome
<p>- Effectiveness (technically success and macroscopic- and microscopic R0<br />
resection) of limited<br />
treatment approach<br />
- 3-year overall and disease free survival<br />
- 5-year overall and disease free survival<br />
- 30-day postoperative morbidity and mortality rate according to the<br />
Clavien-Dindo classification I-V<br />
- Total procedure related costs and cost effectiveness<br />
- Postoperative quality of life</p>
Background summary
The current standard oncological therapy for T1 colonic cancer is an oncologic
resection with lymph node dissection. However, this therapy is associated with
significant morbidity (24%) and mortality (2%). A significant part of the
resected specimens (approximately 50%) shows no high-risk histological features
for lymph node metastasis and therefore en-bloc local resection might be a
valuable alternative. Recently we proved the Colonoscopic-Assisted Laparoscopic
Wedge Resection (CAL-WR) to be a safe and effective technique to remove
endoscopic irresectable colonic lesions. We hypothesize that this local
treatment approach can also be applied as initial treatment for T1-colon
carcinoma and will be associated with less morbidity and mortality, better
quality of life, less procedure related costs and similar survival compared
with a standard oncological resection.
Study objective
The aim of this study is to investigate the safety and efficacy of CAL-WR as
primary and curative colon-preserving treatment for T1 colon cancer. Our
primary endpoint is reduction of oncologic resections for low-risk T1 colon
cancer. As secondary endpoints, we will describe the effectiveness, morbidity,
costs and oncological outcomes (recurrences, overall survival, and disease-free
survival).
Study design
National prospective multicenter longitudinal cohort study
Intervention
NA
Study burden and risks
As we introduce here a minimal invasive local resection as primary treatment
for T1 coloncarcinoma, we expect a significant part of the included patients
(with a ''low-risk'' T1) to avoid a major oncologic resection and its
associated high morbidity and mortality. Therefore, participants in this study
will probably benefit directly from this investigation. Based upon our previous
study (LIMERIC-(18)), we expect no major risks or complications to be
associated with the procedure. The burden associated with participation in this
study is limited to 3-times filling in two short questionnaires. There are no
additional outpatient clinic visits or hospital admissions necessary for this
study compared to current clinical practice.
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
• Lesion macroscopic suspect for T1 colon carcinoma during endoscopy (Hiroshima
2-3)
o Or histologically proven T1 colon carcinoma
• Size < 40mm
• Localized at least > 25cm proximal from the anus (measured endoscopically)
• > 18 years old
Exclusion criteria
• Rectal carcinoma
• Distant metastasis at baseline
• > 50% circumferential growth of the lesion
- Prior endoscopic resection or attempt, lifting not included
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81497.075.22 |
| Research portal | NL-004930 |