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. 2023 Jun 19;23(1):214.
doi: 10.1186/s12876-023-02854-9.

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

Julia Hanevelt #  1 , Jelle F Huisman #  2 , Laura W Leicher  2 , Miangela M Lacle  3 , Milan C Richir  4 , Paul Didden  5 , Joost M J Geesing  6 , Niels Smakman  7 , Jochim S Terhaar Sive Droste  8 , Frank Ter Borg  9 , A Koen Talsma  10 , Ruud W M Schrauwen  11 , Bob J van Wely  12 , Ingrid Schot  13 , Maarten Vermaas  14 , Philip Bos  15 , Colin Sietses  16 , Wouter L Hazen  17 , Dareczka K Wasowicz  18 , David E Ploeg  19 , Dewkoemar Ramsoekh  20 , Jurriaan B Tuynman  21 , Yasser A Alderlieste  22 , Rutger-Jan Renger  23 , Ramon-Michel Schreuder  24 , Johanne G Bloemen  25 , Ineke van Lijnschoten  26 , Esther C J Consten  27 , Daan J Sikkenk  27 , Matthijs P Schwartz  28 , Annelotte Vos  29 , Jordy P W Burger  30 , Bernhard W M Spanier  31 , Nikki Knijn  32 , Wouter H de Vos Tot Nederveen Cappel  2 , Leon M G Moons  5 , Henderik L van Westreenen  33
Affiliations

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

Julia Hanevelt et al. BMC Gastroenterol. .

Erratum in

  • Correction: Limited wedge resection for T1 colon cancer (LIMERIC-II trial) - rationale and study protocol of a prospective multicenter clinical trial.
    Hanevelt J, Huisman JF, Leicher LW, Lacle MM, Richir MC, Didden P, Geesing JMJ, Smakman N, Sive Droste JST, Ter Borg F, Talsma AK, Schrauwen RWM, van Wely BJ, Schot I, Vermaas M, Bos P, Sietses C, Hazen WL, Wasowicz DK, Ploeg DE, Ramsoekh D, Tuynman JB, Alderlieste YA, Renger RJ, Schreuder RM, Bloemen JG, van Lijnschoten I, Consten ECJ, Sikkenk DJ, Schwartz MP, Vos A, Burger JPW, Spanier BWM, Knijn N, Cappel WHVTN, Moons LMG, van Westreenen HL. Hanevelt J, et al. BMC Gastroenterol. 2023 Jul 27;23(1):256. doi: 10.1186/s12876-023-02905-1. BMC Gastroenterol. 2023. PMID: 37501070 Free PMC article. No abstract available.

Abstract

Background: The 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.

Methods: In 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 registration: CCMO register (ToetsingOnline), NL81497.075.22, protocol version 2.3 (October 2022).

Keywords: Colonoscopy-assisted laparoscopic wedge resection; Combined endo-laparoscopic surgery; Early-stage colorectal cancer; T1 colorectal cancer.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart patient enrollment. Legend: ESD—Endoscopic submucosal dissection, eFTR—Endoscopic full-thickness resection, CAL-WR—Colonoscopic-Assisted Laparoscopic Wedge Resection
Fig. 2
Fig. 2
Colonoscopic-Assisted Laparoscopic Wedge Resection (CAL-WR) procedure
Fig. 3
Fig. 3
Flowchart follow-up. Legend: CAL-WR—Colonoscopic-Assisted Laparoscopic Wedge Resection, Low risk pT1 – pT1 colon carcinoma without (lympho-) vascular invasion, poor (high-grade) differentiation and high-grade tumor budding, R0 – radical resection, R1 – irradical resection (resection margin of less than 0.1 mm), Rx—radicality could not be determined, High risk pT1—pT1 colon carcinoma with one or more of the following histological risk factors: (lympho-) vascular invasion, poor (high-grade) differentiation and high-grade tumor budding, CRC – colorectal cancer
See this image and copyright information in PMC

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