Clinical trial · Observational
Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study]
Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study]: Multicenter, Single-Arm Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Colon | Colon Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic modified complete mesocolic excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Laparoscopic modified central mesocolic excision
- description
- Patients receiving laparoscopic colectomy with the concept of modified complete mesocolic excision for right-sided colon cancer
- interventionNames
- Procedure: Laparoscopic modified complete mesocolic excision
Primary outcomes (1)
- measure
- 3 year disease-free survival (DFS)
- timeFrame
- DFS will be measured up to three years after surgery, and the last visit is 14th visit after index surgery.
- description
- The 3 year disease-free survival is defined as the time from surgery until documented recurrence or death from any cause.
Secondary outcomes (4)
- measure
- 3 year overall survival (OS)
- timeFrame
- Three years after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYang 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. PMID 32664881