SCar-biopsies After Malignant Colorectal Polypectomy of Uncertain RAdicality

NCT02328664 | Terminated DMC

• 1 other identifier: SCAPURA-Study
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 36

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Endoscopic resection; Pathology; Rescue surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 90-day mortality after rescue surgery

  91 days from surgery

• The sensitivity of biopsies for residual cancer in the bowel wall

  up to 1 year

• The number of complications (defined according to GCP) after biopsies from the polypectomy scar

  up to 30 days

• The sensitivity of global endoscopic assessment of polypectomy site for residual cancer at initial and follow-up endoscopy (to take scar biopsies)

  up to 1 year

• The proportion of patients with residual cancer in the resected specimen if malignancy was unsuspected during the endoscopic polypectomy

  up to 1 year

Study Arms (1)

Flexible sigmoidoscopy or colonoscopy

OTHER

Subjects will undergo these investigation to take biopsies from the polypectomy scar.

Procedure: Flexible sigmoidoscopy or colonoscopy

Interventions

Flexible sigmoidoscopy or colonoscopy PROCEDURE

Depending on the localization of the scar of the malignant polyp, either a flexible sigmoidoscopy or colonoscopy will be done to take biopsies from the polypectomy scar.

Flexible sigmoidoscopy or colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Tumor budding grade II-III.
• 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.

Sponsors & Collaborators

• Dr. Frank ter Borg MD PhD: lead
• Erasmus Medical Center: collaborator
• The Netherlands Cancer Institute: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• UMC Utrecht: collaborator

Study Sites (36)

Medical Center de Veluwe

Apeldoorn, Gelderland, 7332BP, Netherlands

Location

Gelre Hospitals

Apeldoorn, Gelderland, 7334, Netherlands

Location

Hospital Gelderse Vallei

Ede, Gelderland, 6716RP, Netherlands

Location

Radboud University Medical Center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, 6532SZ, Netherlands

Location

Maastricht University Medical Center

Maastricht, Limburg, 6229, Netherlands

Location

Maasstad Hospital Pantein

Beugen, North Brabant, 5835DV, Netherlands

Location

Amphia Hospital

Breda, North Brabant, 4819EV, Netherlands

Location

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Bernhoven

Uden, North Brabant, 5406PT, Netherlands

Location

The Netherlands Cancer Institute Antoni van Leeuwenhoekhuis

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Medical Center Slotervaart

Amsterdam, North Holland, 1066EC, Netherlands

Location

Onze Lieve Vrouwe Gasthuis (Oost & West)

Amsterdam, North Holland, 1091AC, Netherlands

Location

Academical Medical Center, Gastroenterology department

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Spaarne Gasthuis

Haarlem, North Holland, 2035RC, Netherlands

Location

Deventer Hospital

Deventer, Overijssel, 7416 SE, Netherlands

Location

Ziekenhuis Groep Twente

Hengelo, Overijssel, 7555DL, Netherlands

Location

Isala Clinics

Zwolle, Overijssel, 8025AB, Netherlands

Location

Nij Smellinghe Hospital

Drachten, Provincie Friesland, 9202NN, Netherlands

Location

Antonius Hospital Sneek-Emmeloord

Sneek, Provincie Friesland, 8601ZK, Netherlands

Location

IJsselland Hospital

Capelle aan den IJssel, South Holland, 2906ZC, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, South Holland, 3318AT, Netherlands

Location

Rivas Zorggroep

Gorinchem, South Holland, 4206CC, Netherlands

Location

Groene Hart Hospital

Gouda, South Holland, 2803HH, Netherlands

Location

Alrijne Hospital

Leiden, South Holland, 2334CK, Netherlands

Location

Erasmus Medical Center, Gastroenterology department

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Franciscus Gasthuis

Rotterdam, South Holland, 3045PM, Netherlands

Location

Maasstad Hospital

Rotterdam, South Holland, 3079DZ, Netherlands

Location

Ikazia Hospital

Rotterdam, South Holland, 3083AN, Netherlands

Location

Vlietland Hospital

Schiedam, South Holland, 3118JH, Netherlands

Location

Haga Hospital

The Hague, South Holland, 2545AA, Netherlands

Location

Meander Medical Center

Amersfoort, Utrecht, 3813TZ, Netherlands

Location

Sint Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Martini Hospital

Groningen, 9728NT, Netherlands

Location

University Medical Center Utrecht, Gastroenterology department

Utrecht, 3508 GA, Netherlands

Location

Related Publications (12)

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• Seitz U, Bohnacker S, Seewald S, Thonke F, Brand B, Braiutigam T, Soehendra N. Is endoscopic polypectomy an adequate therapy for malignant colorectal adenomas? Presentation of 114 patients and review of the literature. Dis Colon Rectum. 2004 Nov;47(11):1789-96; discussion 1796-7. doi: 10.1007/s10350-004-0680-2.

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• Meining A, von Delius S, Eames TM, Popp B, Seib HJ, Schmitt W. Risk factors for unfavorable outcomes after endoscopic removal of submucosal invasive colorectal tumors. Clin Gastroenterol Hepatol. 2011 Jul;9(7):590-4. doi: 10.1016/j.cgh.2011.02.002. Epub 2011 Feb 12.

  PMID: 21320641 BACKGROUND

• Benizri EI, Bereder JM, Rahili A, Bernard JL, Vanbiervliet G, Filippi J, Hebuterne X, Benchimol D. Additional colectomy after colonoscopic polypectomy for T1 colon cancer: a fine balance between oncologic benefit and operative risk. Int J Colorectal Dis. 2012 Nov;27(11):1473-8. doi: 10.1007/s00384-012-1464-0. Epub 2012 Mar 29.

  PMID: 22454048 BACKGROUND

• Di Gregorio C, Bonetti LR, de Gaetani C, Pedroni M, Kaleci S, Ponz de Leon M. Clinical outcome of low- and high-risk malignant colorectal polyps: results of a population-based study and meta-analysis of the available literature. Intern Emerg Med. 2014 Mar;9(2):151-60. doi: 10.1007/s11739-012-0772-2. Epub 2012 Mar 27.

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• Kitajima K, Fujimori T, Fujii S, Takeda J, Ohkura Y, Kawamata H, Kumamoto T, Ishiguro S, Kato Y, Shimoda T, Iwashita A, Ajioka Y, Watanabe H, Watanabe T, Muto T, Nagasako K. Correlations between lymph node metastasis and depth of submucosal invasion in submucosal invasive colorectal carcinoma: a Japanese collaborative study. J Gastroenterol. 2004 Jun;39(6):534-43. doi: 10.1007/s00535-004-1339-4.

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  PMID: 9824349 BACKGROUND

• Cooper GS, Xu F, Barnholtz Sloan JS, Koroukian SM, Schluchter MD. Management of malignant colonic polyps: a population-based analysis of colonoscopic polypectomy versus surgery. Cancer. 2012 Feb 1;118(3):651-9. doi: 10.1002/cncr.26340. Epub 2011 Jul 12.

  PMID: 21751204 BACKGROUND

• Ikematsu H, Yoda Y, Matsuda T, Yamaguchi Y, Hotta K, Kobayashi N, Fujii T, Oono Y, Sakamoto T, Nakajima T, Takao M, Shinohara T, Murakami Y, Fujimori T, Kaneko K, Saito Y. Long-term outcomes after resection for submucosal invasive colorectal cancers. Gastroenterology. 2013 Mar;144(3):551-9; quiz e14. doi: 10.1053/j.gastro.2012.12.003. Epub 2012 Dec 8.

  PMID: 23232297 BACKGROUND

• Gijsbers KM, Post Z, Schrauwen RWM, Tang TJ, Bisseling TM, Bac DJ, Veenstra RP, Schreuder RM, Epping Stippel LSM, de Vos Tot Nederveen Cappel WH, Slangen RME, van Lelyveld N, Witteman EM, van Milligen de Wit MAWM, Honkoop P, Alderlieste Y, Ter Borg PJC, van Roermund R, Schmittgens S, Dekker E, Leeuwenburgh I, de Ridder RJJ, Zonneveld AM, Hadithi M, van Leerdam ME, Bruno MJ, Vleggaar FP, Moons LMG, Koch AD, Ter Borg F. Low value of second-look endoscopy for detecting residual colorectal cancer after endoscopic removal. Gastrointest Endosc. 2020 Jul;92(1):166-172. doi: 10.1016/j.gie.2020.01.056. Epub 2020 Feb 25.

  PMID: 32105713 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Frank ter Borg, MD PhD

  Department of Gastroenterology & Hematology, Deventer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD, Gastroenterologist

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 31, 2014
• Study Start: August 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (36)