Selective Organ-Preserving Surgery Using Frozen-Section Guidance for Low Rectal Cancer After Radiation Therapy A Single-Arm Phase II Trial

What this Trial Is About

Researchers are evaluating a selective organ-preserving approach for adults with low rectal cancer located 5 cm or less from the anus who have a near clinical complete response or partial response after radiation therapy. This prospective, single-arm, phase II trial aims to see if using immediate intra-operative frozen-section results during local excision can achieve good 2-year local control while reducing surgery complications and long-term functional problems such as anorectal and urogenital issues. The study focuses on patients who have undergone neoadjuvant radiotherapy and have residual tumors smaller than 2 cm. All participants receive trans-anal full-thickness local excision under general anesthesia. The removed tissue is examined immediately using frozen-section pathology during surgery. If the frozen section shows ypT0-1 stage, the procedure ends and the patient enters a watch-and-wait monitoring phase. If the frozen section shows ypT2-3 stage or positive margins R1, an immediate completion total mesorectal excision TME is performed. If the frozen section shows ypT1-2 but the final paraffin section upgrades the tumor to ypT2-3 or R1, an elective TME is done within 8 weeks. During the study, participants will be monitored for local recurrence, surgical complications within 30 days, and long-term functional outcomes including anal incontinence, sexual dysfunction, and permanent stoma rates over 2 years. Researchers will also compare frozen-section pathology with final pathology results and assess disease-free and overall survival at 3 years. The study enrolls about 27 adults aged 18 to 75 years and includes assessments of quality of life and recovery after surgery.

Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy