Prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non-metastatic right colon cancer (PIONEER study): study protocol of a multicentre single-arm trial
Abstract Background The introduction of complete mesocolic excision (CME) with central vascular ligation (CVL) for right-sided colon cancer has improved the oncologic outcomes. Recently, we have introduced a modified CME (mCME) procedure that keeps the same principles as the originally described CME...
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| Format: | Article |
| Language: | English |
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BMC
2020-07-01
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| Series: | BMC Cancer |
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| Online Access: | http://link.springer.com/article/10.1186/s12885-020-07151-2 |
| _version_ | 1818682278927138816 |
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| author | Seung Yoon Yang Min Jung Kim Bong-Hyeon Kye Yoon Dae Han Min Soo Cho Seung-Yong Jeong Hyeon-Min Cho Hyunki Kim Gyeong Hoon Kang Seung Ho Song Jun Seok Park Ji-Seon Kim Soo Yeun Park Jin Kim Byung Soh Min |
| author_facet | Seung Yoon Yang Min Jung Kim Bong-Hyeon Kye Yoon Dae Han Min Soo Cho Seung-Yong Jeong Hyeon-Min Cho Hyunki Kim Gyeong Hoon Kang Seung Ho Song Jun Seok Park Ji-Seon Kim Soo Yeun Park Jin Kim Byung Soh Min |
| author_sort | Seung Yoon Yang |
| collection | DOAJ |
| description | Abstract Background The introduction of complete mesocolic excision (CME) with central vascular ligation (CVL) for right-sided colon cancer has improved the oncologic outcomes. Recently, we have introduced a modified CME (mCME) procedure that keeps the same principles as the originally described CME but with a more tailored approach. Some retrospective studies have reported the favourable oncologic outcomes of laparoscopic mCME for right-sided colon cancer; however, no prospective multicentre study has yet been conducted. Methods This study is a multi-institutional, prospective, single-arm study evaluating the oncologic outcomes of laparoscopic mCME for adenocarcinoma arising from the right side of the colon. A total of 250 patients will be recruited from five tertiary referral centres in South Korea. The primary outcome of this study is 3-year disease-free survival. Secondary outcome measures include 3-year overall survival, incidence of surgical complications, completeness of mCME, and distribution of metastatic lymph nodes. The quality of laparoscopic mCME will be assessed on the basis of photographs of the surgical specimen and the operation field after the completion of lymph node dissection. Discussion This is a prospective multicentre study to evaluate the oncologic outcomes of laparoscopic mCME for right-sided colon cancer. To the best of our knowledge, this will be the first study to prospectively and objectively assess the quality of laparoscopic mCME. The results will provide more evidence about oncologic outcomes with respect to the quality of laparoscopic mCME in right-sided colon cancer. Trial registration ClinicalTrials.gov ID: NCT03992599 (June 20, 2019). The posted information will be updated as needed to reflect protocol amendments and study progress. |
| first_indexed | 2024-12-17T10:16:19Z |
| format | Article |
| id | doaj.art-70ec7d5ca7e14f3f90e5543de53e8504 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-17T10:16:19Z |
| publishDate | 2020-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-70ec7d5ca7e14f3f90e5543de53e85042022-12-21T21:52:55ZengBMCBMC Cancer1471-24072020-07-0120111010.1186/s12885-020-07151-2Prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non-metastatic right colon cancer (PIONEER study): study protocol of a multicentre single-arm trialSeung Yoon Yang0Min Jung Kim1Bong-Hyeon Kye2Yoon Dae Han3Min Soo Cho4Seung-Yong Jeong5Hyeon-Min Cho6Hyunki Kim7Gyeong Hoon Kang8Seung Ho Song9Jun Seok Park10Ji-Seon Kim11Soo Yeun Park12Jin Kim13Byung Soh Min14Department of Surgery, Yonsei University College of Medicine, Severance HospitalDepartment of Surgery, Seoul National University College of MedicineDepartment of Surgery, Catholic University of Korea School of MedicineDepartment of Surgery, Yonsei University College of Medicine, Severance HospitalDepartment of Surgery, Yonsei University College of Medicine, Severance HospitalDepartment of Surgery, Seoul National University College of MedicineDepartment of Surgery, Catholic University of Korea School of MedicineDepartment of Pathology, Yonsei University College of MedicineDepartment of Pathology, Seoul National University College of MedicineDepartment of Surgery, School of Medicine, Kyungpook National UniversityDepartment of Surgery, School of Medicine, Kyungpook National UniversityDepartment of Surgery, Korea University College of MedicineDepartment of Surgery, School of Medicine, Kyungpook National UniversityDepartment of Surgery, Korea University College of MedicineDepartment of Surgery, Yonsei University College of Medicine, Severance HospitalAbstract Background The introduction of complete mesocolic excision (CME) with central vascular ligation (CVL) for right-sided colon cancer has improved the oncologic outcomes. Recently, we have introduced a modified CME (mCME) procedure that keeps the same principles as the originally described CME but with a more tailored approach. Some retrospective studies have reported the favourable oncologic outcomes of laparoscopic mCME for right-sided colon cancer; however, no prospective multicentre study has yet been conducted. Methods This study is a multi-institutional, prospective, single-arm study evaluating the oncologic outcomes of laparoscopic mCME for adenocarcinoma arising from the right side of the colon. A total of 250 patients will be recruited from five tertiary referral centres in South Korea. The primary outcome of this study is 3-year disease-free survival. Secondary outcome measures include 3-year overall survival, incidence of surgical complications, completeness of mCME, and distribution of metastatic lymph nodes. The quality of laparoscopic mCME will be assessed on the basis of photographs of the surgical specimen and the operation field after the completion of lymph node dissection. Discussion This is a prospective multicentre study to evaluate the oncologic outcomes of laparoscopic mCME for right-sided colon cancer. To the best of our knowledge, this will be the first study to prospectively and objectively assess the quality of laparoscopic mCME. The results will provide more evidence about oncologic outcomes with respect to the quality of laparoscopic mCME in right-sided colon cancer. Trial registration ClinicalTrials.gov ID: NCT03992599 (June 20, 2019). The posted information will be updated as needed to reflect protocol amendments and study progress.http://link.springer.com/article/10.1186/s12885-020-07151-2Modified complete mesocolic excisionLaparoscopic surgeryRight-sided colon cancerOncologic outcomes |
| spellingShingle | Seung Yoon Yang Min Jung Kim Bong-Hyeon Kye Yoon Dae Han Min Soo Cho Seung-Yong Jeong Hyeon-Min Cho Hyunki Kim Gyeong Hoon Kang Seung Ho Song Jun Seok Park Ji-Seon Kim Soo Yeun Park Jin Kim Byung Soh Min Prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non-metastatic right colon cancer (PIONEER study): study protocol of a multicentre single-arm trial BMC Cancer Modified complete mesocolic excision Laparoscopic surgery Right-sided colon cancer Oncologic outcomes |
| title | Prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non-metastatic right colon cancer (PIONEER study): study protocol of a multicentre single-arm trial |
| title_full | Prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non-metastatic right colon cancer (PIONEER study): study protocol of a multicentre single-arm trial |
| title_fullStr | Prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non-metastatic right colon cancer (PIONEER study): study protocol of a multicentre single-arm trial |
| title_full_unstemmed | Prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non-metastatic right colon cancer (PIONEER study): study protocol of a multicentre single-arm trial |
| title_short | Prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non-metastatic right colon cancer (PIONEER study): study protocol of a multicentre single-arm trial |
| title_sort | prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non metastatic right colon cancer pioneer study study protocol of a multicentre single arm trial |
| topic | Modified complete mesocolic excision Laparoscopic surgery Right-sided colon cancer Oncologic outcomes |
| url | http://link.springer.com/article/10.1186/s12885-020-07151-2 |
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