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Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study]
This study is a multi-institutional, prospective, observational study evaluation oncologic outcomes of laparoscopic modified complete mesocolic excision (mCME) on right-sided colon cancer.
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Adenocarcinoma of the Colon | Procedure: Laparoscopic modified complete mesocolic excision |
The present study aims to evaluate the oncological outcomes of laparoscopic mCME on right-sided colon cancer. The right side of the colon was defined as the colon from cecum up to the proximal half of the transverse colon. The number of patients needs to get a 90% power is 250. Patients will be enrolled at five leading centers in South Korea. A complete information leaflet will give to the patients during the first consultation, which will correspond to the enrollment day. The preoperative, intraoperative, and postoperative period will be in complete accordance with the usual care of the center. The baseline demographics and conditions, as well as the perioperative items and the postoperative occurrences, will be recorded through a prior designed case report form. The follow-up encompasses 13 postoperative consultations: 1month, 3 months, after that every 3 months until 36 months.
The primary outcome of this study is 3-year disease-free survival. Secondary outcome measures include 3-year overall survival, the incidence of surgical complications, completeness of mCME, and distribution of metastatic lymph nodes. Review of resected surgical specimens and the operative field after completion of lymph node dissection will be done based on photographs to assess the quality if surgery.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 250 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Years |
| Official Title: | Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study]: Multicenter, Single-Arm Study |
| Actual Study Start Date : | August 1, 2019 |
| Estimated Primary Completion Date : | July 2024 |
| Estimated Study Completion Date : | October 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Laparoscopic modified central mesocolic excision
Patients receiving laparoscopic colectomy with the concept of modified complete mesocolic excision for right-sided colon cancer
|
Procedure: Laparoscopic modified complete mesocolic excision
First, complete kocherization may be required to clear possible tumor spread if the tumor is infiltrating or adhering to the duodenum or perinephric fat tissue. Second, if the tumor is locally advanced, the entire prerenal soft tissue behind Gerota's fascia may need to be cleared, especially for tumors growing toward the posterior. The third difference of mCME with the conventional CME involves the tailored resection of the mesocolon and ileal mesentery according to tumor location. After identifying the root of the middle colic artery, the site of the vascular ligation depends on the location of the tumor. When the tumor is located in the cecum and ascending colon, only the right branch of the middle colic artery is ligated. If the tumor was present in these latter sites, the root of the middle colic artery is ligated.
Other Name: Laparoscopic right hemicolectomy
|
- 3 year disease-free survival (DFS) [ Time Frame: DFS will be measured up to three years after surgery, and the last visit is 14th visit after index surgery. ]The 3 year disease-free survival is defined as the time from surgery until documented recurrence or death from any cause.
- 3 year overall survival (OS) [ Time Frame: Three years after surgery ]The time from surgery until documented death from any cause
- Incidence of surgical complications [ Time Frame: Until four weeks after surgery ]
- Completeness of mCME [ Time Frame: Two weeks after surgery ]A. By reviewing resected surgical specimens based on photographs B. By reviewing the operative field after lymph node dissection and specimen removal based on photographs
- Distribution of metastatic LNs [ Time Frame: Two weeks after surgery ]Lymph nodes retrieved from resected surgical specimens to categorise
| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 1. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; the tumor located between the cecum and the right 1/2 of transverse colon
- 2. Patients suitable for curative surgery older than 19 years old
- 3. ASA grade I-III
- 4. Patients without preoperative treatment
- 5. Informed consent
Exclusion Criteria:
- 1. Informed consent refusal
- 2. Patients who need emergency operation; such as perforation, malignant colonic obstruction
- 3. Preoperative imaging examination results show: distant metastasis
- 4. Hereditary colon cancer
- 5. History of any other malignant tumor in recent 5 years, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin;
- 6. Simultaneous or simultaneous multiple primary colorectal cancer
- 7. Women during Pregnancy or breast feeding period
| Korea, Republic of | |
| Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine | |
| Seoul, Korea, Republic of | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 18, 2019 | ||||
| First Posted Date | June 20, 2019 | ||||
| Last Update Posted Date | October 4, 2019 | ||||
| Actual Study Start Date | August 1, 2019 | ||||
| Estimated Primary Completion Date | July 2024 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
3 year disease-free survival (DFS) [ Time Frame: DFS will be measured up to three years after surgery, and the last visit is 14th visit after index surgery. ] The 3 year disease-free survival is defined as the time from surgery until documented recurrence or death from any cause.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study] | ||||
| Official Title | Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study]: Multicenter, Single-Arm Study | ||||
| Brief Summary |
This study is a multi-institutional, prospective, observational study evaluation oncologic outcomes of laparoscopic modified complete mesocolic excision (mCME) on right-sided colon cancer. 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. |
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| Detailed Description |
The present study aims to evaluate the oncological outcomes of laparoscopic mCME on right-sided colon cancer. The right side of the colon was defined as the colon from cecum up to the proximal half of the transverse colon. The number of patients needs to get a 90% power is 250. Patients will be enrolled at five leading centers in South Korea. A complete information leaflet will give to the patients during the first consultation, which will correspond to the enrollment day. The preoperative, intraoperative, and postoperative period will be in complete accordance with the usual care of the center. The baseline demographics and conditions, as well as the perioperative items and the postoperative occurrences, will be recorded through a prior designed case report form. The follow-up encompasses 13 postoperative consultations: 1month, 3 months, after that every 3 months until 36 months. The primary outcome of this study is 3-year disease-free survival. Secondary outcome measures include 3-year overall survival, the incidence of surgical complications, completeness of mCME, and distribution of metastatic lymph nodes. Review of resected surgical specimens and the operative field after completion of lymph node dissection will be done based on photographs to assess the quality if surgery. |
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| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 3 Years | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with adenocarcinoma arising from the right side of the colon who received laparoscopic mCME. The right side of the colon was defined as the colon from cecum up to the proximal half of transverse colon | ||||
| Condition | Adenocarcinoma of the Colon | ||||
| Intervention | Procedure: Laparoscopic modified complete mesocolic excision
First, complete kocherization may be required to clear possible tumor spread if the tumor is infiltrating or adhering to the duodenum or perinephric fat tissue. Second, if the tumor is locally advanced, the entire prerenal soft tissue behind Gerota's fascia may need to be cleared, especially for tumors growing toward the posterior. The third difference of mCME with the conventional CME involves the tailored resection of the mesocolon and ileal mesentery according to tumor location. After identifying the root of the middle colic artery, the site of the vascular ligation depends on the location of the tumor. When the tumor is located in the cecum and ascending colon, only the right branch of the middle colic artery is ligated. If the tumor was present in these latter sites, the root of the middle colic artery is ligated.
Other Name: Laparoscopic right hemicolectomy
|
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| Study Groups/Cohorts | Laparoscopic modified central mesocolic excision
Patients receiving laparoscopic colectomy with the concept of modified complete mesocolic excision for right-sided colon cancer
Intervention: Procedure: Laparoscopic modified complete mesocolic excision
|
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| Publications * | Yang SY, Kim MJ, Kye BH, Han YD, Cho MS, Jeong SY, Cho HM, Kim H, Kang GH, Song SH, Park JS, Kim JS, Park SY, Kim J, Min BS. 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. 2020 Jul 14;20(1):657. doi: 10.1186/s12885-020-07151-2. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Enrolling by invitation | ||||
| Estimated Enrollment |
250 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | October 2024 | ||||
| Estimated Primary Completion Date | July 2024 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 19 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03992599 | ||||
| Other Study ID Numbers | 4-2018-1162 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Yonsei University | ||||
| Study Sponsor | Yonsei University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Yonsei University | ||||
| Verification Date | October 2019 | ||||
