Colorectal Unit, General & Digestive Surgery Department, Hospital Universitario Son Espases, Palma, Spain.
Instituto de Investigación Sanitaria Illes Balears (IdISBa), Palma, Spain.
BMC Surg. 2024 Oct 7;24(1):292. doi: 10.1186/s12893-024-02558-1.
Colon cancer presents significant surgical challenges that necessitate the development of precise strategies. Standardization with complete mesocolic excision (CME) is common, but some cases require extended resections. This study investigates the use of 3D Image Processing and Reconstruction (3D-IPR) to improve diagnostic accuracy in locally advanced colon cancer (LACC) with suspected infiltration and achieve R0 surgery.
Single-center, prospective, observational, comparative, non-randomized study. •Participants: Patients aged > 18 years undergoing LACC surgery, as indicated by CT scans, confirmed via colonoscopy. Exclusion criteria include neoadjuvant therapy, suspected carcinomatosis on CT, and unresectable tumors. •Interventions: 3D-IPR models are used for surgical planning, providing detailed tumor and surrounding structure metrics. Surgical procedures are guided by CT scans and intraoperative findings, categorized by surgical margins as R0, R1, or R2. •Objective: The primary goal is to evaluate 3D-IPR's utility in achieving R0 resection in LACC with suspected infiltration. Secondary objectives include assessing preoperative surgical strategy, comparing CT reports, detecting adenopathy, and identifying vascularization and anatomical variants. • Outcome: The main outcome is the diagnostic accuracy of 3D-IPR in determining tumor infiltration of neighboring structures compared to conventional CT scans, using definitive pathological reports as the gold standard.
•Recruitment and Number Analyzed: The study aims to recruit about 20 patients annually over two years, focusing on preoperative 3D-IPR analysis and subsequent surgical procedures. •Outcome Parameters: These include loco-regional and distant recurrence rates, peritoneal carcinomatosis, disease-free and overall survival, and mortality due to oncologic progression. •Harms: No additional risks from CT scans, as they are mandatory for staging colon tumors. 3D-IPR is derived from these CT scans.
If successful, this study could provide an objective tool for precise tumor extension delimitation, aiding decision-making for radiologists, surgeons, and multidisciplinary teams. Enhanced staging through 3D-IPR may influence therapeutic strategies, reduce postsurgical complications, and improve the quality of life of patients with LACC.
Trial is registered at ISRCTN registry as ISRCTN81005215. Protocol version I (Date 29/06/2023).
结肠癌手术极具挑战性，需要制定精确的策略。全直肠系膜切除术（CME）的标准化较为常见，但有些情况下需要进行扩展切除。本研究旨在通过 3D 图像处理和重建（3D-IPR）提高局部晚期结肠癌（LACC）疑似浸润的诊断准确性，实现 R0 手术。
单中心、前瞻性、观察性、非随机对照研究。
CT 扫描提示疑似浸润的 LACC 手术患者，年龄大于等于 18 岁，行结肠镜检查确认。排除标准包括新辅助治疗、CT 提示癌性腹膜转移和不可切除的肿瘤。
使用 3D-IPR 模型进行手术规划，提供详细的肿瘤和周围结构指标。手术过程根据 CT 扫描和术中发现进行指导，根据手术切缘分为 R0、R1 或 R2。
主要目的是评估 3D-IPR 在疑似浸润的 LACC 中实现 R0 切除的效用。次要目的包括评估术前手术策略、比较 CT 报告、检测淋巴结、识别血管化和解剖变异。
•招募和分析数量：研究计划每年招募约 20 名患者，为期两年，重点是术前 3D-IPR 分析和随后的手术程序。
•结局参数：包括局部和远处复发率、腹膜癌转移、无病和总生存率以及肿瘤进展导致的死亡率。
•危害：CT 扫描没有额外的风险，因为它们是分期结肠癌所必需的。3D-IPR 是从这些 CT 扫描中衍生出来的。
如果成功，本研究可为精确肿瘤扩展划定提供客观工具，为放射科医生、外科医生和多学科团队提供决策支持。通过 3D-IPR 增强分期可能会影响治疗策略，减少术后并发症，并提高 LACC 患者的生活质量。
试验在 ISRCTN 注册处注册，注册号为 ISRCTN81005215。方案版本 I（日期：2023 年 6 月 29 日）。
