About this trial
Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery. Surgery for early stage rectal cancer can be either a radical surgery (RS) or a local excision (LE).
A radical surgery removes the rectum including the tumor and the lymph nodes through which it spreads, improving survival but with a possible impact in the patients quality of life (QoL). A local excision only removes the tumor and a safety margin of healthy rectum. This has the potential to avoid the possible complications and QoL decrease. However there are some complications after a LE and also poor prognostic factors inherent to the tumor biology that can lead the surgical team to perform a RS after LE with worse outcomes. These are impossible to know before the procedure.
The goal of this registry is to determine the frequency of these poor prognostic biological factors and complications in patients undergoing LE for early rectal cancer.
The main question it aims to answer are:
• How frequently does LE allow for rectum preservation?
Participants will undergo LE for early rectal cancer when it is considered the best treatment by their surgeons according to their expertise and protocols. Patients will follow the standard treatment that would be given to them, and the biological prognostic factors and the appearance of complications will be recorded.
Eligibility criteria
Qualifiers
Patients age 18 years or older.
Histologic proof of infiltrating rectal adenocarcinoma. or
Preoperative biopsy compatible with rectal adenoma or intramucous adenocarcinoma with endoscopic or radiological suspicion of infiltrating adenocarcinoma.
Endoscopic criteria: Kudo´s crypt pattern of V or higher, despite non confirmatory preoperative histology. endoscópicos: patrón de criptas V o superior según la clasificación de Kudo, que define lesiones infiltrantes, a pesar de que la histología preoperatoria no sea confirmatoria .
Disqualifiers
Patients younger than 18 years old.
Rectal neoplasms different from adenocarcinoma.
Neoplasms in which the inferior edge is farther than 2cm proximal to the anorectal verge in the preoperative MR.
Any other clinical stage other than cT1N0M0 (any T>1, N+, or M+).
Trial design
Treatments tested in this trial
- Transanal local excision
Treatment groups
Sponsors and collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead sponsor
Hospital Alemão Oswaldo Cruz
Collaborator
Hospital Universitario La Fe
Collaborator
Complejo Hospitalario Universitario de Vigo
Collaborator