Colorectal Cancer Clinical Trial
— SCAPURAOfficial title:
The Sensitivity of Scar-biopsies for Residual Colorectal Adenocarcinoma After Endoscopic Resection With Uncertain Radicality
NCT number | NCT02328664 |
Other study ID # | SCAPURA-Study |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2015 |
Est. completion date | May 2019 |
Verified date | December 2019 |
Source | Deventer Ziekenhuis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
After endoscopic removal of a colorectal polyp that harbors (unexpected) adenocarcinoma, pathology usually can not guarantee a radical resection from an oncological point of view. In such case, additional surgical resection is advised. However, only in 15% of patients, residual adenocarcinoma is found. This study investigates the sensitivity of biopsies from the polypectomy scar for residual adenocarcinoma.
Status | Terminated |
Enrollment | 246 |
Est. completion date | May 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Aged 18 or above. - Endoscopically removed colorectal lesion with the following pathological characteristics: - A moderately-to-well differentiated adenocarcinoma. - If possible to judge: distance between adenocarcinoma and vertical or lateral resection margin is less than 1 mm. - In case of piecemeal resection: unjudgeable radicality (mostly due to loss of orientation and multiple fragments). - Absence of / unjudgeable lymphatic / vascular invasion. - No or only grade I tumor budding. - No suspicion of dissemination on the following investigations: serum carcino-embryonic antigen, a computer tomographic (CT) scan of the abdomen and a chest X-ray; in case of a rectal tumor (less than 15 cm from the anal verge): an additional magnetic resonance imaging of the rectum. - Operation is advised in agreement with the Dutch Guideline on Colorectal cancer, planned and agreed on by the patient. - Written informed consent is obtained. Exclusion Criteria: - Pathology shows one or more of the following characteristics: - A radical en-bloc resection with a free vertical and lateral margin of ? 1 mm. - A poorly differentiated or signet-cell containing adenocarcinoma. - Lymphatic or vascular invasion (if this feature is unjudgeable due to piecemeal resection, no exclusion is done). - Tumor budding grade II-III. - Suspicion of dissemination on investigations as mentioned in the inclusion criteria. - Patients already receiving anti-tumor treatment for another tumor or a synchronic colorectal cancer. - Patients in whom a second-look endoscopy would require major and unacceptable effort and / or resources, for instance clinical admission for bowel preparation, long travel, general anesthesia, extremely difficult to reach polypectomy site. Such at the decision of the patient and / or treating physician. - Patient is planned for trans-anal surgery. - Patient is not planned for surgery. - Patient is pregnant. - Patient does not provide written informed consent or is unable to provide such. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Meander Medical Center | Amersfoort | Utrecht |
Netherlands | Academical Medical Center, Gastroenterology department | Amsterdam | Noord-Holland |
Netherlands | Medical Center Slotervaart | Amsterdam | Noord-Holland |
Netherlands | Onze Lieve Vrouwe Gasthuis (Oost & West) | Amsterdam | Noord-Holland |
Netherlands | The Netherlands Cancer Institute Antoni van Leeuwenhoekhuis | Amsterdam | Noord-Holland |
Netherlands | Gelre Hospitals | Apeldoorn | Gelderland |
Netherlands | Medical Center de Veluwe | Apeldoorn | Gelderland |
Netherlands | Maasstad Hospital Pantein | Beugen | Noord-Brabant |
Netherlands | Amphia Hospital | Breda | Noord-Brabant |
Netherlands | IJsselland Hospital | Capelle Aan Den IJssel | Zuid-Holland |
Netherlands | Haga Hospital | Den Haag | Zuid-Holland |
Netherlands | Deventer Hospital | Deventer | Overijssel |
Netherlands | Albert Schweitzer Hospital | Dordrecht | Zuid-Holland |
Netherlands | Nij Smellinghe Hospital | Drachten | Friesland |
Netherlands | Hospital Gelderse Vallei | Ede | Gelderland |
Netherlands | Catharina Hospital | Eindhoven | Noord-Brabant |
Netherlands | Rivas Zorggroep | Gorinchem | Zuid-Holland |
Netherlands | Groene Hart Hospital | Gouda | Zuid-Holland |
Netherlands | Martini Hospital | Groningen | |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Spaarne Gasthuis | Haarlem | Noord-Holland |
Netherlands | Ziekenhuis Groep Twente | Hengelo | Overijssel |
Netherlands | Alrijne Hospital | Leiden | Zuid-Holland |
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Netherlands | Sint Antonius Hospital | Nieuwegein | Utrecht |
Netherlands | Canisius Wilhelmina Hospital | Nijmegen | Gelderland |
Netherlands | Radboud University Medical Center | Nijmegen | Gelderland |
Netherlands | Erasmus Medical Center, Gastroenterology department | Rotterdam | Zuid-Holland |
Netherlands | Franciscus Gasthuis | Rotterdam | Zuid-Holland |
Netherlands | Ikazia Hospital | Rotterdam | Zuid-Holland |
Netherlands | Maasstad Hospital | Rotterdam | Zuid-Holland |
Netherlands | Vlietland Hospital | Schiedam | Zuid-Holland |
Netherlands | Antonius Hospital Sneek-Emmeloord | Sneek | Friesland |
Netherlands | Bernhoven | Uden | Noord-Brabant |
Netherlands | University Medical Center Utrecht, Gastroenterology department | Utrecht | |
Netherlands | Isala Clinics | Zwolle | Overijssel |
Lead Sponsor | Collaborator |
---|---|
Dr. Frank ter Borg MD PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, The Netherlands Cancer Institute, UMC Utrecht |
Netherlands,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of biopsies for residual cancer | The number of patients with endoscopic biopsies containing adenocarcinoma divided by the number of patients with adenocarcinoma in the resected specimen. | up to 1 year | |
Secondary | 90-day mortality after rescue surgery | The number of patients that died within 91 day after the operation for presumed residual adenocarcinoma. | 91 days from surgery | |
Secondary | The sensitivity of biopsies for residual cancer in the bowel wall | The number of patients with endoscopic biopsies containing adenocarcinoma divided by the number of patients with adenocarcinoma in the resected bowel wall (regardless of regional lymph nodes) | up to 1 year | |
Secondary | The number of complications (defined according to GCP) after biopsies from the polypectomy scar | The number of patients with bleeding or perforation after taking biopsies from the polypectomy scar, requiring at least prolongation of treatment, or admission to hospital, or delay or speeding up of surgery. | up to 30 days | |
Secondary | The sensitivity of global endoscopic assessment of polypectomy site for residual cancer at initial and follow-up endoscopy (to take scar biopsies) | The number of patients in whom the endoscopic resection initially and/or at follow-up endoscopic was assessed as incomplete and who also have residual cancer in the surgically resected specimen divided by the total number of patients in whom the endoscopic resection was judged to be incomplete. | up to 1 year | |
Secondary | The proportion of patients with residual cancer in the resected specimen if malignancy was unsuspected during the endoscopic polypectomy | The number of patients in whom the malignancy was initially unsuspected during endoscopic polypectomy and who also have residual cancer in the surgical specimen divided by the total number of patients in whom the malignancy was initially unsuspected during endoscopic polypectomy. | up to 1 year |
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