Evidence map›Paper›PMID 37337197›Full record

ArticleBMC gastroenterology2023

Limited wedge resection for T1 colon cancer (LIMERIC-II trial) - rationale and study protocol of a prospective multicenter clinical trial.

Julia Hanevelt, Jelle F Huisman, Laura W Leicher, Miangela M Lacle, Milan C Richir, Paul Didden, Joost M J Geesing, Niels Smakman, Jochim S Terhaar Sive Droste, Frank Ter Borg and 27 more

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in BMC gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.6field-weighted citation impact, top 14% of its field
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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

37 authors at 16 institutions in 1 country.

Julia Hanevelt *Department of Gastroenterology and Hepatology, Isala, Dokter Van Heesweg 2, 28025 AB, Zwolle, The Netherlands. j.hanevelt@isala.nl.
Jelle F Huisman *Department of Gastroenterology and Hepatology, Isala, Dokter Van Heesweg 2, 28025 AB, Zwolle, The Netherlands.
Laura W LeicherDepartment of Gastroenterology and Hepatology, Isala, Dokter Van Heesweg 2, 28025 AB, Zwolle, The Netherlands.
Miangela M LacleDepartment of Pathology, University Medical Center Utrecht, Utrecht, The Netherlands.
Milan C RichirDepartment of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Paul DiddenDepartment of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
Joost M J GeesingDepartment of Gastroenterology & Hepatology, Diakonessenhuis Hospital, Utrecht, The Netherlands.
Niels SmakmanDepartment of Surgery, Diakonessenhuis Hospital, Utrecht, The Netherlands.
Jochim S Terhaar Sive DrosteDepartment of Gastroenterology & Hepatology, Jeroen Bosch Ziekenhuis, Den Bosch, The Netherlands.
Frank Ter BorgDepartment of Gastroenterology & Hepatology, Deventer Ziekenhuis, Deventer, The Netherlands.
A Koen TalsmaDepartment of Surgery, Deventer Ziekenhuis, Deventer, The Netherlands.
Ruud W M SchrauwenDepartment of Gastroenterology & Hepatology, Ziekenhuis Bernhoven, Uden, The Netherlands.
Bob J van WelyDepartment of Surgery, Ziekenhuis Bernhoven, Uden, The Netherlands.
Ingrid SchotDepartment of Gastroenterology & Hepatology, IJsselland Ziekenhuis, Capelle a/d Ijssel, The Netherlands.
Maarten VermaasDepartment of Surgery, IJsselland Ziekenhuis, Capellle a/d Ijssel, The Netherlands.
Philip BosDepartment of Gastroenterology & Hepatology, Ziekenhuis Gelderse Vallei, Ede, The Netherlands.
Colin SietsesDepartment of Surgery, Ziekenhuis Gelderse Vallei, Ede, The Netherlands.
Wouter L HazenDepartment of Gastroenterology & Hepatology, Elisabeth-Tweesteden Ziekenhuis, Tilburg, The Netherlands.
Dareczka K WasowiczDepartment of Surgery, Elisabeth-Tweesteden Ziekenhuis, Tilburg, The Netherlands.
David E PloegDepartment of Pathology, Elisabeth-Tweesteden Ziekenhuis, Tilburg, The Netherlands.
Dewkoemar RamsoekhDepartment of Gastroenterology & Hepatology, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands.
Jurriaan B TuynmanDepartment of Surgery, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands.
Yasser A AlderliesteDepartment of Gastroenterology & Hepatology, Beatrixziekenhuis - Rivas, Gorinchem, The Netherlands.
Rutger-Jan RengerDepartment of Surgery, Beatrixziekenhuis - Rivas, Gorinchem, The Netherlands.
Ramon-Michel SchreuderDepartment of Gastroenterology & Hepatology, Catharina Ziekenhuis, Eindhoven, The Netherlands.
Johanne G BloemenDepartment of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands.
Ineke van LijnschotenEurofins/PAMM NL, Veldhoven, The Netherlands.
Esther C J ConstenDepartment of Surgery, Meander Medisch Centrum, Amersfoort, The Netherlands.
Daan J SikkenkDepartment of Surgery, Meander Medisch Centrum, Amersfoort, The Netherlands.
Matthijs P SchwartzDepartment of Gastroenterology & Hepatology, Meander Medisch Centrum, Amersfoort, The Netherlands.
Annelotte VosDepartment of Pathology, Meander Medisch Centrum, Amersfoort, The Netherlands.
Jordy P W BurgerDepartment of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
Bernhard W M SpanierDepartment of Gastroenterology & Hepatology, Rijnstate Hospital, Arnhem, The Netherlands.
Nikki KnijnPathology DNA, Location Arnhem, The Netherlands.
Wouter H de Vos Tot Nederveen CappelDepartment of Gastroenterology and Hepatology, Isala, Dokter Van Heesweg 2, 28025 AB, Zwolle, The Netherlands.
Leon M G MoonsDepartment of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
Henderik L van WestreenenDepartment of Surgery, Isala, Zwolle, The Netherlands.
Isala · NLMeander Medisch Centrum · NLUniversity Medical Center Utrecht · NLElisabeth-TweeSteden Ziekenhuis · NLCatharina Ziekenhuis · NLDeventer Ziekenhuis · NLDiakonessenhuis hospital · NLIJsselland Ziekenhuis · NLRijnstate Hospital · NLZiekenhuis Bernhoven · NLZiekenhuis Gelderse Vallei · NLAmsterdam UMC Location Vrije Universiteit Amsterdam · NLAmsterdam University Medical Centers · NLBeatrix Kinderziekenhuis · NLEurofins (Netherlands) · NLJeroen Bosch Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe sole presence of deep submucosal invasion is shown to be associated with a limited risk of lymph node metastasis. This justifies a local excision of suspected deep submucosal invasive colon carcinomas (T1 CCs) as a first step treatment strategy. Recently Colonoscopy-Assisted Laparoscopic Wedge Resection (CAL-WR) has been shown to be able to resect pT1 CRCs with a high R0 resection rate, but the long term outcomes are lacking. The aim of this study is to evaluate the safety, effectiveness and long-term oncological outcomes of CAL-WR as primary treatment for patients with suspected superficial and also deeply-invasive T1 CCs.

methodsIn this prospective multicenter clinical trial, patients with a macroscopic and/or histologically suspected T1 CCs will receive CAL-WR as primary treatment in order to prevent unnecessary major surgery for low-risk T1 CCs. To make a CAL-WR technically feasible, the tumor may not include > 50% of the circumference and has to be localized at least 25 cm proximal from the anus. Also, there should be sufficient distance to the ileocecal valve to place a linear stapler. Before inclusion, all eligible patients will be assessed by an expert panel to confirm suspicion of T1 CC, estimate invasion depth and subsequent advise which local resection techniques are possible for removal of the lesion. The primary outcome of this study is the proportion of patients with pT1 CC that is curatively treated with CAL-WR only and in whom thus organ-preservation could be achieved. Secondary outcomes are 1) CAL-WR's technical success and R0 resection rate for T1 CC, 2) procedure-related morbidity and mortality, 3) 5-year overall and disease free survival, 4) 3-year metastasis free survival, 5) procedure-related costs and 6) impact on quality of life. A sample size of 143 patients was calculated. DISCUSSION: CAL-WR is a full-thickness local resection technique that could also be effective in removing pT1 colon cancer. With the lack of current endoscopic local resection techniques for > 15 mm pT1 CCs with deep submucosal invasion, CAL-WR could fill the gap between endoscopy and major oncologic surgery. The present study is the first to provide insight in the long-term oncological outcomes of CAL-WR.

trial registrationCCMO register (ToetsingOnline), NL81497.075.22, protocol version 2.3 (October 2022).

Indexed as

CarcinomaColonic NeoplasmsColorectal NeoplasmsColonoscopyEndoscopy, GastrointestinalHumansMulticenter Studies as TopicProspective StudiesQuality of LifeRetrospective StudiesTreatment OutcomeColonoscopy-assisted laparoscopic wedge resectionCombined endo-laparoscopic surgeryEarly-stage colorectal cancerT1 colorectal cancer

Identifiers

PMID37337197
PMCPMC10278298
OpenAlexW4381140702

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Registered trials

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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.