NCT07846046Not yet recruiting
Endoscopic (EID) Versus Surgical (TAMIS) Local Excision for Early Stage Rectal Cancer
Endoscopic Intermuscular Dissection Versus Transanal Minimally Invasive Surgery for Local Excision of Early Rectal Cancer: a Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 246 (estimated)
- First submitted
- 13 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Mar 2029
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Colorectal cancer
- NCT number
- NCT07846046
What you commit to
- Study type: Interventional
- Planned participants: 246
- From 1 Sept 2026 to the primary completion date, 1 Mar 2029
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior endoscopic or surgical resection attempts of the tumour.
- Recurrent cancer after previous surgical or endoscopic local resection.
- Inflammatory bowel disease (IBD) with previous inflammation of the rectum.
- Previous pelvic irradiation or neoadjuvant therapy.
- Concomitant malignancies or other severe medical conditions that, in the opinion of the multidisciplinary team (MDT), are likely to result in death within 5 years.
Other
- A patient who meets one or more of the following criteria will be excluded from participation in this study:
- Lesions involving more than 50% of the circumference.
- Total lesion size larger than 6 cm.
- Severe pre-existing faecal incontinence with impaired quality of life.
- Poor general health that prevents the use of general anaesthesia.
- Inability or contraindication to undergo MRI scan.
- AJCC stage II, III or IV CRC within the last 5 years or synchronous CRC.
- Inability to complete questionnaires or sign informed consent.
- Known pregnancy.
Who the study is looking for
- To be eligible to participate in this study, a patient must meet all of the following criteria:
- Adult patients (≥ 18 years of age).
- Suspected rectal D-SMIC based on optical diagnosis using narrow-band imaging:
- 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.
- Tumour with its lower border situated on or below the level of the sigmoid take off as shown on rectal MRI.
- Staging rectal MRI confirms absence of suspicious malignant mesorectal lymph nodes, defined as mucinous lymph nodes, perirectal lymph nodes \>9 mm in short-axis diameter, or ≥7 mm for lateral lymph nodes (classified as certain cN+), or 5-9 mm peri-rectal lymph nodes with at least 2 suspect morphological features: round shape, heterogeneity and/or irregular borders (classified as doubtful cN+).
- Staging rectal MRI confirms absence of tumour deposits.
- Staging rectal MRI confirms absence of extramural vascular invasion (EMVI).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noordwest Ziekenhuisgroep Coordinator of this site? Confirm its status | Alkmaar | Netherlands | Unknown status |
| Flevoziekenhuis Coordinator of this site? Confirm its status | Almere Stad | Netherlands | Unknown status |
| Meander Medisch Centrum Coordinator of this site? Confirm its status | Amersfoort | Netherlands | Unknown status |
| OLVG Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Antoni van Leeuwenhoek Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| IJsselland Ziekenhuis Coordinator of this site? Confirm its status | Capelle aan den IJssel | Netherlands | Unknown status |
| Deventer Ziekenhuis Coordinator of this site? Confirm its status | Deventer | Netherlands | Unknown status |
| Catharina Ziekenhuis Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Spaarne Gasthuis Coordinator of this site? Confirm its status | Haarlem | Netherlands | Unknown status |
| Dijklander Ziekenhuis Coordinator of this site? Confirm its status | Hoorn | Netherlands | Unknown status |
| Leiden Universitair Medisch Centrum Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| St. Antonius Ziekenhuis Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Laurentius Ziekenhuis Coordinator of this site? Confirm its status | Roermond | Netherlands | Unknown status |
| Erasmus Medisch Centrum Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Haaglanden Medisch Centrum Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Isala Coordinator of this site? Confirm its status | Zwolle | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.