In this clinical trial, we compare the endoscopic technique, endoscopic intermuscular dissection (EID), with the surgical technique, transanal minimally invasive surgery (TAMIS) for the treatment of early stage rectal cancer. The aim of this study is to investigate whether one of them leads to better outcomes.
Researchers will focus particularly on:
* How effectively each technique completely removes the cancer * How quickly patients recover after treatment and whether complications occur * Outcomes after three years (does the cancer go away, or does it come back?) * The impact of both techniques on bowel function and quality of life
Participants will:
* Be randomly assigned to receive either surgical or endoscopic treatment for their rectal cancer * Keep a diary twice a day to record pain symptoms and recovery during the first 30 days after treatment and complete questionnaires within a 3 year period * Visit the clinic for follow-up appointments within a 3 year period
Adult patients (≥ 18 years of age).
Hiroshima C2/3, JNET 3, NICE III, Kudo Vn pit pattern.
The presence of non-lifting together with features of superficial submucosal invasion (Hiroshima C1, JNET 2B, Kudo Vi pit pattern).
MRI shows cT1-T2 invasion and minimum of 1 mm preserved muscularis propria.
Lesions involving more than 50% of the circumference.
Total lesion size larger than 6 cm.
Prior endoscopic or surgical resection attempts of the tumour.
Recurrent cancer after previous surgical or endoscopic local resection.
Parallel
Endoscopic Intermuscular Dissection (EID)
Procedure/SurgeryEID is an endoscopic local excision technique used for the resection of early-stage rectal tumours. The procedure uses a flexible endoscope to dissect between the inner (circular) and outer (longitudinal) muscles of the m. propria leaving the outer rectal wall layers intact. It is performed under conscious sedation by a gastroenterologist.
Transanal Minimally Invasive Surgery (TAMIS)
Procedure/SurgeryTAMIS is a minimally invasive transanal surgical technique used for the local excision of early-stage rectal tumours. A transanal platform is inserted into the anus to allow access with laparoscopic instruments. The procedure may be performed using a full-thickness or an intermuscular approach, based on tumour characteristics and surgical planning. The procedure is performed under general anesthesia by surgeons.
Rate of complete R0 resection between TAMIS and EID procedures
The rate of complete R0 resection, defined as complete en-bloc resection with cancer free resection margins of \>0.1mm, will be evaluated.
Incidence of procedure-related adverse events
Procedure-related adverse events will be registered and recorded according to standard clinical practice in the Dutch Registration of Complications of Endoscopy (DRCE) or Dutch Surgical Colorectal Audit (DSCA). Details of all procedure-related complications within 30 days will be recorded in the eCRF and entered in ALEA database.
Postprocedural pain scores
Post-procedural recovery and pain will be assessed using a pain diary for the first 30 days following the procedure. Participants will record their daily pain intensity using a visual analogue scale (VAS), as well as their use of analgesic medication, until they report no pain for two consecutive days.
Recovery scores
Post-procedural recovery will be assessed for the first 30 days following the procedure. Level of recovery, defined as the participant's ability to perform activities of daily living, will be recorded at on days 1, 3, 7, 14, and 30 post-procedure.
Rate of curative local excisions for pT1sm2-3 rectal cancer
The rate of curative local excisions for pT1sm2-3 rectal cancer will be recorded. A curative local excision refers to pT1sm2-3 lesions with a complete R0 resection and the absence of additional histological risk factors.
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Amsterdam UMC, location VUmc
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
