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This interventional, non-randomized, prospective trial aims to evaluate the role of endoscopic resection following neoadjuvant treatment in patients with locally advanced rectal cancer.
Phase I focuses on assessing the feasibility, safety and efficacy of endoscopic resection of residual scar or superficial residual neoplastic tissue following neoadjuvant treatment.
Phase II explores the potential of this approach to guide patient selection for total mesorectal excision and to serve as a definitive treatment option for those with limited residual disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete clinical response | Experimental | Defined as the presence of residual clear scar seen on endoscopic examination, without evidence of invasive disease (>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan. |
|
| Near complete clinical response | Experimental | Defined as the presence of irregular mucosa or small mucosal nodules or superficial ulceration or persisting erythema of the scar seen on endoscopic examination, without evidence of invasive disease (>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan. |
|
| Incomplete response with presence of superficial residual tissue | Experimental | Defined as the presence of superficial residual tissue without features of deep invasion seen on endoscopic examination, without evidence of invasive disease (>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan. |
|
| No significant response | Active Comparator | Persistant local signs of malignancy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic resection | Procedure | Eligible patients will undergo endoscopic submucosal dissection (ESD) or endoscopic intermuscular dissection (EID) after two to eight weeks of nCRT completion, depending on the used neo-adjuvant regimen. Procedures will be performed using the GIF EZ-1500 endoscope (Olympus America, Center Valley, PA, USA) and an electrosurgical unit (VIO 300 D; Erbe, Germany) to power the electrosurgical knife (1.5-mm DualKnife J, Olympus America). For mucosal incision, Endocut or Drycut mode will be used, while Precise, Swift or Spray Coagulation modes will support submucosal dissection and hemostasis. An initial submucosal lift will be created by Glycéol Gel injection. The ERBE Flushing Pump (Erbe, Germany) will supply further submucosal lift during dissection through foot pedal-controlled, pressurized injections of methylene blue and saline solution delivered via the DualKnife J's ceramic-tipped tubing. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Endoscopic Resection | Feasibility of the endoscopic resection technique in the context of locally advanced rectal cancer treated with neoadjuvant therapy including radio-chemotherapy. This will be assessed by the curative, en-bloc, and R0 resection rates. | From the endoscopic procedure date to the date of reported pathology results, estimated to a maximum of 15 days |
| Disease Recurrence | This will be assessed by the rate of local or distant recurrences and the need of salvage surgery within 1, 3 and 5 years following the neoadjuvant treatment and endoscopic resection. | From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Complete endoscopic resection rate | This is defined as the absence of residual visible tissue after endoscopic resection | The day of the endoscopic procedure |
| En-bloc endoscopic resection rate |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Duration | The average time taken to perform the endoscopic resection, measured in minutes and reported by the endoscopist | The day of the endoscopic procedure |
| Length of Hospital Stay | Number of days patients are hospitalized post-procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariana Figueiredo | Contact | +32 23533332 | mariana.figueiredo@stpierre-bru.be | |
| Amélie Deleporte | Contact | +32 25354144 | amelie.deleporte@stpierre-bru.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint Pierre | Recruiting | Brussels | 1000 | Belgium |
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| Short interval restaging | Behavioral | Close follow-up and endoscopic re-evaluation four to eight weeks after the initial evaluation*. *Defined as the first endoscopic evaluation after completion of the neoadjuvant treatment |
|
| Total mesorectal excision | Procedure | This technique consists of the surgical complete removal of the rectum, together with the surrounding mesorectum lymphovascular fatty tissue (mesorectum). |
|
This is defined as a single piece endoscopic resection, with clear margins
| The day of the endoscopic procedure |
| Incidence of procedure-related technical complications (Safety of the technique) | This will be defined as any complication occuring during the performance of the endoscopic procedure, such as muscle galling, rectal muscle perforation, minor or major bleeding, anesthesia-related adverse events, endoscopic material defect | The day of the endoscopic procedure |
| Incidence of early procedure-related adverse events | This will be assessed by evaluating the incidence of procedure-related adverse events (AEs) and serious adverse events (SAEs) within 30 days post-procedure. This includes bleeding rates, perforation rates, infection rates among other complications. | Starting the next day following the endoscopic procedure until 30 days after the procedure |
| Incidence of late procedure-related adverse events (Long-term safety of the procedure) | This will be assessed by evaluating the incidence of late procedure-related complications within 1, 3 and 5 years after the procedure. This includes delayed haemorrhage, delayed perforation, stenosis, stricture, infection and local pain among other complications | From the endoscopic procedure date until 5 years after the procedure date |
| Endoscopic tumor characteristics | This will be assessed by the correlation between endoscopic tumor characteristics and the rates of recurrence and salvage surgery. Endoscopic tumor characteristics include the presence of a non-lifting sign, muscle retraction sign, fibrosis, and the description of vessels density (low/moderate/high) | From the endoscopic procedure date until 5 years after the procedure date |
| Pathologic tumor characteristics | This will be assessed by the correlation between residual tumor characteristics (e.g. resected specimen surface, the presence of residual tumor, tumor differentiation, margin status, lymphovascular invasion (LVI), perineural invasion (PNI), fibrosis degree, tumor budding) and the rates of recurrence and salvage surgery | From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy |
| Pathological response | This will be assessed by the correlation between the degree of pathological response (e.g., complete, partial, or poor response) and the rates of recurrence and salvage surgery | From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy |
| Molecular biomarkers | This will be assessed by evaluating molecular biomarkers such as Next Generation Sequencing (NGS) on the resected specimen, and correlating these findings with the rates of recurrence and salvage surgery | From the pathologic report date until 5 years after the endoscopic procedure date |
| Survival Outcomes | Overall survival (OS) and disease-free survival (DFS) at 1, 3 and 5 years. | From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy |
| From the endoscopic procedure date to the date of the patient's discharge from the hospital, up to 30 days |
| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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