Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study protocol of a prospective multicenter clinical trial
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...
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BMC
2023-06-01
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| Series: | BMC Gastroenterology |
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| Online Access: | https://doi.org/10.1186/s12876-023-02854-9 |
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| author | 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 A. Koen Talsma Ruud W. M. Schrauwen Bob J. van Wely Ingrid Schot Maarten Vermaas Philip Bos Colin Sietses Wouter L. Hazen Dareczka K. Wasowicz David E. Ploeg Dewkoemar Ramsoekh Jurriaan B. Tuynman Yasser A. Alderlieste Rutger-Jan Renger Ramon-Michel Schreuder Johanne G. Bloemen Ineke van Lijnschoten Esther C. J. Consten Daan J. Sikkenk Matthijs P. Schwartz Annelotte Vos Jordy P. W. Burger Bernhard W. M. Spanier Nikki Knijn Wouter H. de Vos Tot Nederveen Cappel Leon M. G. Moons Henderik L. van Westreenen |
| author_facet | 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 A. Koen Talsma Ruud W. M. Schrauwen Bob J. van Wely Ingrid Schot Maarten Vermaas Philip Bos Colin Sietses Wouter L. Hazen Dareczka K. Wasowicz David E. Ploeg Dewkoemar Ramsoekh Jurriaan B. Tuynman Yasser A. Alderlieste Rutger-Jan Renger Ramon-Michel Schreuder Johanne G. Bloemen Ineke van Lijnschoten Esther C. J. Consten Daan J. Sikkenk Matthijs P. Schwartz Annelotte Vos Jordy P. W. Burger Bernhard W. M. Spanier Nikki Knijn Wouter H. de Vos Tot Nederveen Cappel Leon M. G. Moons Henderik L. van Westreenen |
| author_sort | Julia Hanevelt |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-03-12T21:08:52Z |
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| id | doaj.art-4ba8031c268740b3aaa2fa4600dde659 |
| institution | Directory Open Access Journal |
| issn | 1471-230X |
| language | English |
| last_indexed | 2024-03-12T21:08:52Z |
| publishDate | 2023-06-01 |
| publisher | BMC |
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| series | BMC Gastroenterology |
| spelling | doaj.art-4ba8031c268740b3aaa2fa4600dde6592023-07-30T11:16:49ZengBMCBMC Gastroenterology1471-230X2023-06-012311910.1186/s12876-023-02854-9Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study protocol of a prospective multicenter clinical trialJulia Hanevelt0Jelle F. Huisman1Laura W. Leicher2Miangela M. Lacle3Milan C. Richir4Paul Didden5Joost M. J. Geesing6Niels Smakman7Jochim S. Terhaar Sive Droste8Frank ter Borg9A. Koen Talsma10Ruud W. M. Schrauwen11Bob J. van Wely12Ingrid Schot13Maarten Vermaas14Philip Bos15Colin Sietses16Wouter L. Hazen17Dareczka K. Wasowicz18David E. Ploeg19Dewkoemar Ramsoekh20Jurriaan B. Tuynman21Yasser A. Alderlieste22Rutger-Jan Renger23Ramon-Michel Schreuder24Johanne G. Bloemen25Ineke van Lijnschoten26Esther C. J. Consten27Daan J. Sikkenk28Matthijs P. Schwartz29Annelotte Vos30Jordy P. W. Burger31Bernhard W. M. Spanier32Nikki Knijn33Wouter H. de Vos Tot Nederveen Cappel34Leon M. G. Moons35Henderik L. van Westreenen36Department of Gastroenterology and Hepatology, IsalaDepartment of Gastroenterology and Hepatology, IsalaDepartment of Gastroenterology and Hepatology, IsalaDepartment of Pathology, University Medical Center UtrechtDepartment of Surgery, University Medical Center UtrechtDepartment of Gastroenterology and Hepatology, University Medical Center UtrechtDepartment of Gastroenterology & Hepatology, Diakonessenhuis HospitalDepartment of Surgery, Diakonessenhuis HospitalDepartment of Gastroenterology & Hepatology, Jeroen Bosch ZiekenhuisDepartment of Gastroenterology & Hepatology, Deventer ZiekenhuisDepartment of Surgery, Deventer ZiekenhuisDepartment of Gastroenterology & Hepatology, Ziekenhuis BernhovenDepartment of Surgery, Ziekenhuis BernhovenDepartment of Gastroenterology & Hepatology, IJsselland ZiekenhuisDepartment of Surgery, IJsselland ZiekenhuisDepartment of Gastroenterology & Hepatology, Ziekenhuis Gelderse ValleiDepartment of Surgery, Ziekenhuis Gelderse ValleiDepartment of Gastroenterology & Hepatology, Elisabeth-Tweesteden ZiekenhuisDepartment of Surgery, Elisabeth-Tweesteden ZiekenhuisDepartment of Pathology, Elisabeth-Tweesteden ZiekenhuisDepartment of Gastroenterology & Hepatology, Amsterdam UMC Location VUmcDepartment of Surgery, Amsterdam UMC Location VUmcDepartment of Gastroenterology & Hepatology, Beatrixziekenhuis - RivasDepartment of Surgery, Beatrixziekenhuis - RivasDepartment of Gastroenterology & Hepatology, Catharina ZiekenhuisDepartment of Surgery, Catharina ZiekenhuisEurofins/PAMM NLDepartment of Surgery, Meander Medisch CentrumDepartment of Surgery, Meander Medisch CentrumDepartment of Gastroenterology & Hepatology, Meander Medisch CentrumDepartment of Pathology, Meander Medisch CentrumDepartment of Surgery, Rijnstate HospitalDepartment of Gastroenterology & Hepatology, Rijnstate HospitalPathology DNADepartment of Gastroenterology and Hepatology, IsalaDepartment of Gastroenterology and Hepatology, University Medical Center UtrechtDepartment of Surgery, IsalaAbstract 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).https://doi.org/10.1186/s12876-023-02854-9T1 colorectal cancerEarly-stage colorectal cancerCombined endo-laparoscopic surgeryColonoscopy-assisted laparoscopic wedge resection |
| spellingShingle | 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 A. Koen Talsma Ruud W. M. Schrauwen Bob J. van Wely Ingrid Schot Maarten Vermaas Philip Bos Colin Sietses Wouter L. Hazen Dareczka K. Wasowicz David E. Ploeg Dewkoemar Ramsoekh Jurriaan B. Tuynman Yasser A. Alderlieste Rutger-Jan Renger Ramon-Michel Schreuder Johanne G. Bloemen Ineke van Lijnschoten Esther C. J. Consten Daan J. Sikkenk Matthijs P. Schwartz Annelotte Vos Jordy P. W. Burger Bernhard W. M. Spanier Nikki Knijn Wouter H. de Vos Tot Nederveen Cappel Leon M. G. Moons Henderik L. van Westreenen Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study protocol of a prospective multicenter clinical trial BMC Gastroenterology T1 colorectal cancer Early-stage colorectal cancer Combined endo-laparoscopic surgery Colonoscopy-assisted laparoscopic wedge resection |
| title | Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study protocol of a prospective multicenter clinical trial |
| title_full | Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study protocol of a prospective multicenter clinical trial |
| title_fullStr | Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study protocol of a prospective multicenter clinical trial |
| title_full_unstemmed | Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study protocol of a prospective multicenter clinical trial |
| title_short | Limited wedge resection for T1 colon cancer (LIMERIC-II trial) – rationale and study protocol of a prospective multicenter clinical trial |
| title_sort | limited wedge resection for t1 colon cancer limeric ii trial rationale and study protocol of a prospective multicenter clinical trial |
| topic | T1 colorectal cancer Early-stage colorectal cancer Combined endo-laparoscopic surgery Colonoscopy-assisted laparoscopic wedge resection |
| url | https://doi.org/10.1186/s12876-023-02854-9 |
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