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Colorectal CancerSCAPURANCT02328664

SCar-biopsies After Malignant Colorectal Polypectomy of Uncertain RAdicality

A study testing Flexible sigmoidoscopy or colonoscopy in people with Colorectal Cancer, run by Dr. Frank ter Borg MD PhD at 36 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Flexible sigmoidoscopy or colonoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
36 sitesNetherlands
Study dates
Aug 2015to May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

Netherlands36 sites

  • Meander Medical Center

    Amersfoort, Utrecht, 3813TZ

  • The Netherlands Cancer Institute Antoni van Leeuwenhoekhuis

    Amsterdam, North Holland, 1066 CX

  • Medical Center Slotervaart

    Amsterdam, North Holland, 1066EC

  • Onze Lieve Vrouwe Gasthuis (Oost & West)

    Amsterdam, North Holland, 1091AC

  • Academical Medical Center, Gastroenterology department

    Amsterdam, North Holland, 1105 AZ

  • Medical Center de Veluwe

    Apeldoorn, Gelderland, 7332BP

  • Gelre Hospitals

    Apeldoorn, Gelderland, 7334

  • Maasstad Hospital Pantein

    Beugen, North Brabant, 5835DV

  • Amphia Hospital

    Breda, North Brabant, 4819EV

  • IJsselland Hospital

    Capelle aan den IJssel, South Holland, 2906ZC

  • Deventer Hospital

    Deventer, Overijssel, 7416 SE

  • Albert Schweitzer Hospital

    Dordrecht, South Holland, 3318AT

  • Nij Smellinghe Hospital

    Drachten, Provincie Friesland, 9202NN

  • Hospital Gelderse Vallei

    Ede, Gelderland, 6716RP

  • Catharina Hospital

    Eindhoven, North Brabant, 5623EJ

  • Rivas Zorggroep

    Gorinchem, South Holland, 4206CC

  • Groene Hart Hospital

    Gouda, South Holland, 2803HH

  • University Medical Center Groningen

    Groningen, 9700 RB

  • Martini Hospital

    Groningen, 9728NT

  • Spaarne Gasthuis

    Haarlem, North Holland, 2035RC

  • Ziekenhuis Groep Twente

    Hengelo, Overijssel, 7555DL

  • Alrijne Hospital

    Leiden, South Holland, 2334CK

  • Maastricht University Medical Center

    Maastricht, Limburg, 6229

  • Sint Antonius Hospital

    Nieuwegein, Utrecht, 3435CM

  • Radboud University Medical Center

    Nijmegen, Gelderland, 6525GA

  • Canisius Wilhelmina Hospital

    Nijmegen, Gelderland, 6532SZ

  • Erasmus Medical Center, Gastroenterology department

    Rotterdam, South Holland, 3015 CE

  • Franciscus Gasthuis

    Rotterdam, South Holland, 3045PM

  • Maasstad Hospital

    Rotterdam, South Holland, 3079DZ

  • Ikazia Hospital

    Rotterdam, South Holland, 3083AN

  • Vlietland Hospital

    Schiedam, South Holland, 3118JH

  • Antonius Hospital Sneek-Emmeloord

    Sneek, Provincie Friesland, 8601ZK

  • Haga Hospital

    The Hague, South Holland, 2545AA

  • Bernhoven

    Uden, North Brabant, 5406PT

  • University Medical Center Utrecht, Gastroenterology department

    Utrecht, 3508 GA

  • Isala Clinics

    Zwolle, Overijssel, 8025AB

Other trials in Netherlands

About this study

Official title: The Sensitivity of Scar-biopsies for Residual Colorectal Adenocarcinoma After Endoscopic Resection With Uncertain Radicality

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.

Read the detailed description

Rationale: colorectal polyps may harbor adenocarcinoma. Numbers are increasing due to the nationwide colorectal screening program. After endoscopic removal, rescue surgery is often performed because radicality can not be guaranteed by the pathologist. However, in 85% of surgical specimen no residual malignancy is found. Given morbidity and mortality associated with surgery a method to diagnose residual cancer is needed.

Biopsies from the polypectomy site are variably used to reduce the likelihood of residual tumor at the polypectomy site under these circumstances. However, the sensitivity of such biopsies is unknown.

Objective: to evaluate the sensitivity of second-look endoscopic biopsies from the polypectomy site for residual tumor.

Study design: prospective cross-sectional design using a multi-center approach. Study population: patients planned for rescue surgery for the sole reason of (potentially) irradical endoscopic resection of a colorectal adenocarcinoma without poor differentiation, lymphovascular invasion or tumor budding and without other signs of dissemination.

Intervention: endoscopic biopsies from the polypectomy site before operation. Main study parameters/endpoints: sensitivity of second-look biopsies from the polypectomy site for residual tumor in the resected bowel and postoperative mortality. Various other factors will be assessed that might be associated with residual cancer.

Nature and extent of the burden and risks associated with participation and benefit: Depending on the situation: a): In case a tattoo needs to be done of the polypectomy site, a second endoscopy is done anyway and taking biopsies (painless) will be of no extra burden; b): In case no tattoo needs to be done a sigmoidoscopy (lesion distal to the splenic flexure) or colonoscopy (proximal to the splenic flexure) needs to be arranged for the purpose of this study. A sigmoidoscopy takes 10-20 minutes. Preparation consists of two enemas. A colonoscopy takes 20-30 minutes. Preparation consists of drinking 3 litre of MoviPrep®, both usually doe at home. Notice that the patient has recent experience with colonoscopy. If necessary, both investigations can be arranged under conscious sedation (the rule in colonoscopy), which also implies day-care admission. The risk of complications of a second endoscopy is estimated < 1:5000. The benefit of a 2nd colonoscopy is the discovery of new polyps in 10-25% of cases.

Being tested
Flexible sigmoidoscopy or colonoscopy
Keywords
Endoscopic resection, Pathology, Rescue surgery
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flexible sigmoidoscopy or colonoscopyProcedure or surgery

    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.

Study groups in NCT02328664
Study groupRoleWhat they receive
Flexible sigmoidoscopy or colonoscopyOtherSubjects will undergo these investigation to take biopsies from the polypectomy scar.
Receives: Procedure: Flexible sigmoidoscopy or colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 1 year

Secondary outcomes (5)

  1. 90-day mortality after rescue surgery

    The number of patients that died within 91 day after the operation for presumed residual adenocarcinoma.

    Measured: 91 days from surgery

  2. 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)

    Measured: up to 1 year

  3. 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.

    Measured: up to 30 days

  4. 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.

    Measured: up to 1 year

  5. 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.

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2014 (estimated)
  2. Study startAug 2015
  3. Primary completionMay 2019
  4. Study completionMay 2019

Why it stopped: Interim analysis showed no added value of second look endoscopy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02328664
Sponsor's protocol ID
SCAPURA-Study
Acronym
SCAPURA
Status last verified
Dec 2019
First submitted
15 Dec 2014
Last updated
17 Dec 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Data collection is within current OpenClinica standard and not shared

Publications

  • Mitchell PJ, Haboubi NY. The malignant adenoma: when to operate and when to watch. Surg Endosc. 2008 Jul;22(7):1563-9. doi: 10.1007/s00464-008-9850-y. Epub 2008 Mar 25.

    PubMed 18363065

  • 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.

    PubMed 15622570

  • Butte JM, Tang P, Gonen M, Shia J, Schattner M, Nash GM, Temple LK, Weiser MR. Rate of residual disease after complete endoscopic resection of malignant colonic polyp. Dis Colon Rectum. 2012 Feb;55(2):122-7. doi: 10.1097/DCR.0b013e3182336c38.

    PubMed 22228153

  • 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.

    PubMed 21320641

  • 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.

    PubMed 22454048

  • 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.

    PubMed 22451095

  • 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.

    PubMed 15235870

  • Ueno H, Mochizuki H, Hashiguchi Y, Shimazaki H, Aida S, Hase K, Matsukuma S, Kanai T, Kurihara H, Ozawa K, Yoshimura K, Bekku S. Risk factors for an adverse outcome in early invasive colorectal carcinoma. Gastroenterology. 2004 Aug;127(2):385-94. doi: 10.1053/j.gastro.2004.04.022.

    PubMed 15300569

  • Netzer P, Forster C, Biral R, Ruchti C, Neuweiler J, Stauffer E, Schonegg R, Maurer C, Husler J, Halter F, Schmassmann A. Risk factor assessment of endoscopically removed malignant colorectal polyps. Gut. 1998 Nov;43(5):669-74. doi: 10.1136/gut.43.5.669.

    PubMed 9824349

  • 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.

    PubMed 21751204

  • 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.

    PubMed 23232297

  • 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.

    PubMed 32105713

Questions about this trial

What is this clinical trial studying?

A study testing Flexible sigmoidoscopy or colonoscopy in people with Colorectal Cancer, run by Dr. Frank ter Borg MD PhD at 36 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Interim analysis showed no added value of second look endoscopy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of biopsies for residual cancer (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02328664, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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