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Rectal Cancer Stage IENSURENCT07846046

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

A study testing Endoscopic Intermuscular Dissection (EID) and Transanal Minimally Invasive Surgery (TAMIS) in people with Rectal Cancer Stage I, run by Amsterdam UMC, location VUmc at 19 sites in Netherlands.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer Stage I
What is being tested?
Endoscopic Intermuscular Dissection (EID) and Transanal Minimally Invasive Surgery (TAMIS)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
19 sitesNetherlands
Study dates
1 Sep 2026to 1 Sep 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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).

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elena A Kasantsidis, MD contact

+31 651768033

e.a.kasantsidis@amsterdamumc.nl

19 sites in 1 country

Netherlands19 sites

  • NoordWest Ziekenhuisgroep

    Alkmaar

    Wing Liu, +31 72 - 548 3324, w.s.liu@nwz.nl

    Mich Dunker, MD PhD

  • Flevoziekenhuis

    Almere Stad

    Krista Lam, +31 36 868 86 16, krlam@flevoziekenhuis.nl

    Anthony van de Ven, MD

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

    Nienke Hennequin, +31 33 8505050, nl.hennequin@meandermc.nl

    Esther Consten, MD PhD

  • Amsterdam UMC

    Amsterdam, 1081 HV

    Elena A Kasantsidis, MD, +31 651768033, ENSURE@amsterdamumc.nl

    Elena Kasantsidis, MD

  • Antoni Van Leeuwenhoek

    Amsterdam

    Yanaika Tankink, +31 020 512 9111, y.tankink@nki.nl

    Brechtje Grotenhuis, MD PhD

  • OLVG

    Amsterdam

    Simone Röttgering, +31 20 510 87 77, s.rottgering@olvg.nl

    Michael Gerhards, MD PhD

  • Ijsselland Ziekenhuis

    Capelle aan den IJssel

    Sita Willigen, +31 102585180, swilligen@ysl.nl

    Pascal Doornebosch, MD

  • Deventer Ziekenhuis

    Deventer

    Alinda Guitink, +31 (570) 53 51 05, a.guitink@dz.nl

    Frank ter Borg, MD

  • Catharina Ziekenhuis

    Eindhoven

    Monique Monique van Dillen - Schilders, +31 402399750, researchmdl@catharinaziekenhuis.nl

    Ramon Michel Schreuder, MD

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

    Annika Dommering-Blankenstein, +31 (050) 361 92 59, j.f.blankenstein@umcg.nl

    Wieke Holwerda, w.holwerda@umcg.nl

  • Spaarne Gasthuis

    Haarlem

  • Dijklander Ziekenhuis

    Hoorn

    Maisha van der Zon, +31 229257823, DOC@dijklander.nl

    Joris van den Broek, MD

  • Leiden Universitair Medisch Centrum

    Leiden

    Jurjen Boonstra, MD PhD, +31 71 526 35 75, j.j.boonstra@lumc.nl

    Jurjen Boonstra, MD PhD

  • St. Antonius Ziekenhuis

    Nieuwegein

  • Laurentius Ziekenhuis

    Roermond

    Annette Meijer, +31(475) 38 27 68, annette.meijer@lzr.nl

    Jeroen Leijtens, MD

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

    Milko van Langen, +31 107040572, m.vanlangen@erasmusmc.nl

    Arjun Koch, MD PhD

  • Haaglanden Medisch Centrum

    The Hague

    Angela van Egmond, +31 88 979 43 07, angela.van.egmond@haaglandenmc.nl

    Andreas Marinelli, MD PhD

  • University Medical Center Utrecht

    Utrecht, 3584 CX

    Linda Wissenlink, +31 088 75 56276, l.e.wisselink@umcutrecht.nl

    Leon Moons, MD PhD

  • Isala

    Zwolle

    Lieke Smeets, +31 88 624 62 23, research.chirurgie@isala.nl

    Erik van Westreenen, MD PhD

Other trials in Netherlands

About this study

Official title: Endoscopic Intermuscular Dissection Versus Transanal Minimally Invasive Surgery for Local Excision of Early Rectal Cancer: a Multicenter Randomized Controlled Trial

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:

Read more
  • 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
Read the detailed description

In the Netherlands, more than 3,000 people are diagnosed with rectal cancer each year. Approximately one-third of these patients have early-stage disease (cT1-2N0M0). Due to the low risk of lymph node metastasis, these cancers are potentially suitable for local, organ-preserving treatment. If histological analysis confirms complete removal without high-risk features, major rectal surgery can be avoided. For suspected deep submucosal invasive cancer of the rectum, a local excision (LE) can be performed by gastroenterologists using EID or by surgeons using TAMIS. Although both LE approaches are considered standard treatment for early stage rectal cancer (T1b), they have never been directly compared. This national study aims to compare the efficacy, safety, and cost-effectiveness of these two approaches. Should both techniques prove equally effective at completely removing rectal T1b, EID may offer a less burdensome and more cost-effective treatment option.

Being tested
Endoscopic Intermuscular Dissection (EID), Transanal Minimally Invasive Surgery (TAMIS)
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
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Intermuscular Dissection (EID)Procedure or surgery

    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.

  • Transanal Minimally Invasive Surgery (TAMIS)Procedure or surgery

    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.

Study groups in NCT07846046
Study groupRoleWhat they receive
Endoscopic intermuscular dissection (EID)Active comparatorA 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.
Receives: Procedure: Endoscopic Intermuscular Dissection (EID)
Transanal minimally invasive surgery (TAMIS)Active comparatorA 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.
Receives: Procedure: Transanal Minimally Invasive Surgery (TAMIS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Assessed immediately after local excision procedure

Secondary outcomes (19)

  1. 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.

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

  2. 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.

    Measured: VAS scores will be recorded for 30 days post-procedure

  3. 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.

    Measured: Assessed 30 days post-procedure

  4. 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.

    Measured: Assessed immediately after local excision procedure

  5. Dissection plane evaluation

    The rate of concordance between the definitive dissection plane and initially intended dissection plane prior to local excision (e.g., presence of longitudinal m. propria following an intended intermuscular dissection) will be evaluated. Only CRC pathologists trained within the PATCH study will assess the EID and TAMIS specimens to minimize interobserver variability.

    Measured: Assessed immediately after local excision procedure

  6. Quality of local excision specimen

    The quality of local excision specimens will be reviewed by a CRC pathologist for segment fragmentation, margin assessment, and the presence of muscularis propria underneath the invasive front (circular/longitudinal). Histological handling and evaluation of the resection specimen will be performed at participating centers according to standard care procedures. Only CRC pathologists trained within the PATCH study will handle EID and TAMIS specimens to minimize interobserver variability.

    Measured: Assessed immediately after local excision procedure

  7. Postoperative adverse events

    In the event that a total mesorectal excision (TME) is performed after local excision, post-operative adverse events (Clavien-Dindo classification) will be assessed for the first 30 days following TME.

    Measured: Assessed for the first 30 days post-operatively

  8. TME specimen quality after EID vs TAMIS

    In the event that a total mesorectal excision (TME) is performed after local excision, the quality of completion surgery will be systematically assessed. This includes TME specimen quality (Quirke classification).

    Measured: Assessed immediately after TME

  9. Circumferential resection margin status following completion surgery

    In the event that a total mesorectal excision (TME) is performed after local excision, the quality of completion surgery will be systematically assessed. This includes circumferential resection margin status.

    Measured: Assessed immediately after TME

  10. Conversion rate to laparotomy

    In the event that a total mesorectal excision (TME) is performed after local excision, the quality of completion surgery will be systematically assessed. This includes conversion rate to laparotomy.

    Measured: Assessed immediately after TME

  11. Rate of non-restorative TME procedures

    In the event that a total mesorectal excision (TME) is performed after local excision, the quality of completion surgery will be systematically assessed. This includes rate of non-restorative procedures.

    Measured: Assessed immediately after TME

  12. Functional Outcomes

    Functional outcomes will be measured using the validated Low Anterior Resection Syndrome (LARS) score at baseline, 1, 3, 6, and 12 months. The LARS score is 5-question survey tool used to measure bowel dysfunction after rectal cancer surgery. Total points range from 0 to 42, in which a higher scores indicate more severe symptoms and poor bowel functionality.

    Measured: Functional outcomes will be measured via LARS scores within a period of 12 months.

  13. Health related quality of life (QLQ-C30)

    Health related Quality of Life (QoL) will be assessed using the validated Quality of Life Questionnaire - Core 30 (QLQ-C30) surveys. The QLQ-C30 contains 30 questions that measure the health-related quality of life of cancer patients. All of the scales and single-items range from 0 to 100. A higher score for the functioning scales and global health status implies a better level of functioning. Higher scores on the symptom and single-item scales indicate a higher level of symptoms. Questionnaires will be sent at baseline, 1, 3, 12, and 36 months. All questionnaires will be sent at predefined intervals electronically or collected on paper forms.

    Measured: Questionnaires will be completed within a period of 3 years.

  14. Health related quality of life (QLQ-CR29)

    Health related Quality of Life (QoL) will be assessed using the validated Quality of Life Questionnaire - Colorectal Research 29 (QLQ-CR29). This survey contains 29 questions regarding burden of symptoms, side effects, body image, and sexual functioning. Scores scale from 0-100 with higher scores on symptom scales indicating a higher symptom burden, while higher scores on functional scales indicate better functionality. Questionnaires will be sent at baseline, 1, 3, 12, and 36 months. All questionnaires will be sent at predefined intervals electronically or collected on paper forms.

    Measured: Surveys will be completed within a period of 3 years.

  15. Health related quality of life (EQ-5D-5L)

    Health-related quality of life (QoL) will be assessed using the validated EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-level scale from 1 (no problems) to 5 (extreme problems), with higher scores indicating greater impairment in the respective health dimension.

    The EQ-5D-5L will be completed at baseline and at 1, 3, 12, and 36 months post-procedure. Questionnaires will be completed electronically or, where necessary, using paper forms.

    Measured: Surveys will be completed within a period of 3 years.

  16. Rectal preservation and stoma free survival

    The use of stoma and rates of rectal preservation will be measured within a 3 year period.

    Measured: Following completion of procedure to end of follow-up at 3 years

  17. Cancer recurrence rates

    Intramural, locoregional, and distant 3-year cancer recurrence rates will be measured.

    Measured: Cancer recurrences will be measured over a 3 year follow-up period

  18. Survival Rates

    Three-year disease-specific and overall survival will be measured within the 3 year follow-up period.

    Measured: Survival will be measured within the 3 year follow-up period.

  19. Healthcare costs

    Healthcare costs will be measured using the validated iMCQ and iPCQ questionnaires at 1, 3, 12 and 36 months.

    Measured: Healthcare costs will be measured from the time of enrollment to the end of the follow-up period at 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion1 Sep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants with early stage rectal cancer (T1b) will be randomly assigned to receive endoscopic intermuscular dissection (EID) or transanal minimally invasive surgery (TAMIS).
Masking
None (open label)
Enrolment
246 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07846046
Sponsor's protocol ID
NL-010393
Acronym
ENSURE
Status last verified
Sep 2026
First submitted
13 Aug 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic Intermuscular Dissection (EID) and Transanal Minimally Invasive Surgery (TAMIS) in people with Rectal Cancer Stage I, run by Amsterdam UMC, location VUmc at 19 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elena A Kasantsidis, MD (+31 651768033, e.a.kasantsidis@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of complete R0 resection between TAMIS and EID procedures (time frame: Assessed immediately after local excision procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07846046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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