Evidence map›Paper›PMID 36513968›Full record

ArticleBMC gastroenterology2022

Long-term oncological outcomes of endoscopic full-thickness resection after previous incomplete resection of low-risk T1 CRC (LOCAL-study): study protocol of a national prospective cohort study.

L W Zwager, L M G Moons, A Farina Sarasqueta, M M Laclé, S C Albers, R Hompes, K C M J Peeters, F C Bekkering, J J Boonstra, F Ter Borg and 29 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors.

L W ZwagerDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Centers Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
L M G MoonsDepartment of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
A Farina SarasquetaDepartment of Pathology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
M M LacléDepartment of Pathology, University Medical Center Utrecht, Utrecht, The Netherlands.
S C AlbersDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Centers Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
R HompesDepartment of Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands.
K C M J PeetersDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
F C BekkeringDepartment of Gastroenterology and Hepatology, IJsselland Hospital, Capelle Aan Den Ijssel, The Netherlands.
J J BoonstraDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
F Ter BorgDepartment of Gastroenterology and Hepatology, Deventer Hospital, Deventer, The Netherlands.
P R BosDepartment of Gastroenterology and Hepatology, Gelderse Vallei, Ede, The Netherlands.
G J BulteDepartment of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
E A R GielisseDepartment of Gastroenterology and Hepatology, Rode Kruis Hospital, Beverwijk, The Netherlands.
W L HazenDepartment of Gastroenterology and Hepatology, Elisabeth Tweesteden Hospital, Tilburg, The Netherlands.
W R Ten HoveDepartment of Gastroenterology and Hepatology, Alrijne Medical Group, Leiden, The Netherlands.
M H M G HoubenDepartment of Gastroenterology and Hepatology, Haga Teaching Hospital, the Hague, The Netherlands.
M W MundtDepartment of Gastroenterology and Hepatology, Flevoziekenhuis, Almere, The Netherlands.
W B NagengastDepartment of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.
L E PerkDepartment of Gastroenterology and Hepatology, Haaglanden Medical Center, The Hague, The Netherlands.
R QuispelDepartment of Gastroenterology and Hepatology, Reinier de Graaf, Delft, The Netherlands.
S T RietdijkDepartment of Gastroenterology and Hepatology, OLVG, Amsterdam, The Netherlands.
F J Rando MunozDepartment of Gastroenterology and Hepatology, Nij Smellinghe Hospital, Drachten, The Netherlands.
R J J de RidderDepartment of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, The Netherlands.
M P SchwartzDepartment of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, The Netherlands.
R M SchreuderDepartment of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands.
T C J SeerdenDepartment of Gastroenterology and Hepatology, Amphia Hospital, Breda, The Netherlands.
H van der SluisDepartment of Gastroenterology and Hepatology, Isala Clinics, Zwolle, The Netherlands.
B W van der SpekDepartment of Gastroenterology and Hepatology, Noordwest Hospital Group, Alkmaar, The Netherlands.
J W A StraathofDepartment of Gastroenterology and Hepatology, Màxima Medical Center, Veldhoven, The Netherlands.
J S Terhaar Sive DrosteDepartment of Gastroenterology and Hepatology, Jeroen Bosch Hospital, S' Hertogenbosch, The Netherlands.
M S VlugDepartment of Gastroenterology and Hepatology, Dijklander Hospital, Hoorn, The Netherlands.
W van de VrieDepartment of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
B L A M WeustenDepartment of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands.
T D de WijkersloothDepartment of Gastrointestinal Oncology, Netherlands Cancer Institute/Antoni Van Leeuwenhoek, Amsterdam, The Netherlands.
H J WoltersDepartment of Gastroenterology and Hepatology, Martini Hospital, Groningen, The Netherlands.
P FockensDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Centers Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
E DekkerDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Centers Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
B A J BastiaansenDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Centers Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. b.a.bastiaansen@amsterdamumc.nl.
the Dutch eFTR Working Group

Funding

Maarten van der Weijden foundation 2022-34
6 · The paper itself

Abstract

backgroundT1 colorectal cancer (CRC) without histological high-risk factors for lymph node metastasis (LNM) can potentially be cured by endoscopic resection, which is associated with significantly lower morbidity, mortality and costs compared to radical surgery. An important prerequisite for endoscopic resection as definite treatment is the histological confirmation of tumour-free resection margins. Incomplete resection with involved (R1) or indeterminate (Rx) margins is considered a strong risk factor for residual disease and local recurrence. Therefore, international guidelines recommend additional surgery in case of R1/Rx resection, even in absence of high-risk factors for LNM. Endoscopic full-thickness resection (eFTR) is a relatively new technique that allows transmural resection of colorectal lesions. Local scar excision after prior R1/Rx resection of low-risk T1 CRC could offer an attractive minimal invasive strategy to achieve confirmation about radicality of the previous resection or a second attempt for radical resection of residual luminal cancer. However, oncologic safety has not been established and long-term data are lacking. Besides, surveillance varies widely and requires standardization. METHODS/

designIn this nationwide, multicenter, prospective cohort study we aim to assess feasibility and oncological safety of completion eFTR following incomplete resection of low-risk T1 CRC. The primary endpoint is to assess the 2 and 5 year luminal local tumor recurrence rate. Secondary study endpoints are to assess feasibility, percentage of curative eFTR-resections, presence of scar tissue and/or complete scar excision at histopathology, safety of eFTR compared to surgery, 2 and 5 year nodal and/or distant tumor recurrence rate and 5-year disease-specific and overall-survival rate. DISCUSSION: Since the implementation of CRC screening programs, the diagnostic rate of T1 CRC is steadily increasing. A significant proportion is not recognized as cancer before endoscopic resection and is therefore resected through conventional techniques primarily reserved for benign polyps. As such, precise histological assessment is often hampered due to cauterization and fragmentation and frequently leads to treatment dilemmas. This first prospective trial will potentially demonstrate the effectiveness and oncological safety of completion eFTR for patients who have undergone a previous incomplete T1 CRC resection. Hereby, substantial surgical overtreatment may be avoided, leading to treatment optimization and organ preservation. Trial registration Nederlands Trial Register, NL 7879, 16 July 2019 ( https://trialregister.nl/trial/7879 ).

Indexed as

Colorectal NeoplasmsNeoplasm Recurrence, LocalCicatrixHumansLymphatic MetastasisMulticenter Studies as TopicNeoplasm, ResidualNeoplasm StagingProspective StudiesRetrospective StudiesTreatment OutcomeColorectal cancerEndoscopic full-thickness resectionMinimal invasive local treatment optionsT1 colorectal cancer

Identifiers

PMID36513968
PMCPMC9749288

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.