Endoscopic (EID) Versus Surgical (TAMIS) Local Excision for Early Stage Rectal Cancer

NCT07846046 | Not Yet Recruiting DMC

• 1 other identifier: NL-010393
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Rectal Cancer Stage I

Keywords

Early Stage Rectal Cancer; Local Excision; T1b rectal cancer; Deep submucosal invasive rectal cancer; Endoscopic intermuscular dissection (EID); Transanal minimally invasive surgery (TAMIS); Organ-preserving treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed immediately after local excision procedure

Secondary Outcomes (19)

• Incidence of procedure-related adverse events

  Procedure-related adverse events will be recorded for 30 days post-procedure.

• Postprocedural pain scores

  VAS scores will be recorded for 30 days post-procedure

• Recovery scores

  Assessed 30 days post-procedure

• Rate of curative local excisions for pT1sm2-3 rectal cancer

  Assessed immediately after local excision procedure

• Dissection plane evaluation

  Assessed immediately after local excision procedure

Study Arms (2)

Endoscopic intermuscular dissection (EID)

ACTIVE COMPARATOR

A participant randomly allocated to the EID arm will undergo an EID procedure at one of the participating study centres. Pre-procedural preparation and perioperative management will follow the standard-of-care protocols. The EID procedure will be performed according to the procedure definition and study protocol.

Procedure: Endoscopic Intermuscular Dissection (EID)

Transanal minimally invasive surgery (TAMIS)

ACTIVE COMPARATOR

A participant randomly allocated to the TAMIS arm will undergo a TAMIS procedure at one of the participating study centres. Participants will be prepared according to the standard-of-care protocol. TAMIS will be performed as a full-thickness approach according to the procedure protocol; however, for lesions located in areas with limited or absent mesorectal fat, a full-thickness excision should be avoided. In these cases, an intermuscular approach may be adopted. The planned dissection plane (full-thickness or intermuscular) will be determined by the study steering committee based on preoperative radiographic and endoscopic assessment.

Procedure: Transanal Minimally Invasive Surgery (TAMIS)

Interventions

Endoscopic Intermuscular Dissection (EID) PROCEDURE

EID 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.

Endoscopic intermuscular dissection (EID)

Transanal Minimally Invasive Surgery (TAMIS) PROCEDURE

TAMIS 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.

Transanal minimally invasive surgery (TAMIS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Prior endoscopic or surgical resection attempts of the tumour.
• Recurrent cancer after previous surgical or endoscopic local resection.
• Severe pre-existing faecal incontinence with impaired quality of life.
• Inflammatory bowel disease (IBD) with previous inflammation of the rectum.
• Previous pelvic irradiation or neoadjuvant therapy.
• Poor general health that prevents the use of general anaesthesia.
• Inability or contraindication to undergo MRI scan.
• 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.
• 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.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (19)

NoordWest Ziekenhuisgroep

Alkmaar, Netherlands

Location

Flevoziekenhuis

Almere Stad, Netherlands

Location

Meander Medisch Centrum

Amersfoort, 3813 TZ, Netherlands

Location

Amsterdam UMC

Amsterdam, 1081 HV, Netherlands

Location

Antoni Van Leeuwenhoek

Amsterdam, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

Ijsselland Ziekenhuis

Capelle aan den IJssel, Netherlands

Location

Deventer Ziekenhuis

Deventer, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Spaarne Gasthuis

Haarlem, Netherlands

Location

Dijklander Ziekenhuis

Hoorn, Netherlands

Location

Leiden Universitair Medisch Centrum

Leiden, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Laurentius Ziekenhuis

Roermond, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Isala

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Transanal Endoscopic Surgery

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Natural Orifice Endoscopic Surgery; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Proctoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Barbara Bastiaansen, MD

  Amsterdam University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena A Kasantsidis, MD

CONTACT

+31 651768033; e.a.kasantsidis@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Model Details: Participants with early stage rectal cancer (T1b) will be randomly assigned to receive endoscopic intermuscular dissection (EID) or transanal minimally invasive surgery (TAMIS).

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: September 29, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2032
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

NL (19)