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

22 september 2026 bijgewerkt door: Barbara Bastiaansen, Amsterdam UMC, location VUmc

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:

  • 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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

246

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Nederland
      • Alkmaar, Nederland
        • NoordWest Ziekenhuisgroep
        • Contact:
        • Hoofdonderzoeker:
          • Mich Dunker, MD PhD
      • Almere Stad, Nederland
        • Flevoziekenhuis
        • Contact:
        • Hoofdonderzoeker:
          • Anthony van de Ven, MD
      • Amersfoort, Nederland, 3813 TZ
        • Meander Medisch Centrum
        • Contact:
        • Hoofdonderzoeker:
          • Esther Consten, MD PhD
      • Amsterdam, Nederland
        • OLVG
        • Contact:
        • Hoofdonderzoeker:
          • Michael Gerhards, MD PhD
      • Amsterdam, Nederland, 1081 HV
        • Amsterdam UMC
        • Contact:
        • Onderonderzoeker:
          • Elena Kasantsidis, MD
        • Hoofdonderzoeker:
          • Barbara Bastiaansen, MD
      • Amsterdam, Nederland
        • Antoni Van Leeuwenhoek
        • Contact:
        • Hoofdonderzoeker:
          • Brechtje Grotenhuis, MD PhD
      • Capelle aan den IJssel, Nederland
        • Ijsselland Ziekenhuis
        • Contact:
        • Hoofdonderzoeker:
          • Pascal Doornebosch, MD
      • Deventer, Nederland
        • Deventer Ziekenhuis
        • Contact:
          • Alinda Guitink
          • Telefoonnummer: +31 (570) 53 51 05
          • E-mail: a.guitink@dz.nl
        • Hoofdonderzoeker:
          • Frank ter Borg, MD
      • Eindhoven, Nederland
        • Catharina Ziekenhuis
        • Contact:
        • Hoofdonderzoeker:
          • Ramon Michel Schreuder, MD
      • Groningen, Nederland, 9713 GZ
        • Universitair Medisch Centrum Groningen
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Wouter Nagengast, MD PhD
      • Haarlem, Nederland
        • Spaarne Gasthuis
      • Hoorn, Nederland
        • Dijklander Ziekenhuis
        • Contact:
        • Hoofdonderzoeker:
          • Joris van den Broek, MD
      • Leiden, Nederland
        • Leiden Universitair Medisch Centrum
        • Contact:
        • Hoofdonderzoeker:
          • Jurjen Boonstra, MD PhD
      • Nieuwegein, Nederland
        • St. Antonius Ziekenhuis
      • Roermond, Nederland
        • Laurentius Ziekenhuis
        • Contact:
        • Hoofdonderzoeker:
          • Jeroen Leijtens, MD
      • Rotterdam, Nederland, 3015 GD
        • Erasmus Medisch Centrum
        • Contact:
        • Hoofdonderzoeker:
          • Arjun Koch, MD PhD
      • The Hague, Nederland
        • Haaglanden Medisch Centrum
        • Contact:
        • Hoofdonderzoeker:
          • Andreas Marinelli, MD PhD
      • Utrecht, Nederland, 3584 CX
        • University Medical Center Utrecht
        • Contact:
        • Hoofdonderzoeker:
          • Leon Moons, MD PhD
      • Zwolle, Nederland
        • Isala
        • Contact:
        • Hoofdonderzoeker:
          • Erik van Westreenen, MD PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion criteria:

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).

Exclusion criteria:

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Endoscopic intermuscular dissection (EID)

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)

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.
Actieve vergelijker: Transanal minimally invasive surgery (TAMIS)

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)

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of complete R0 resection between TAMIS and EID procedures
Tijdsspanne: Assessed immediately after local excision procedure

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of procedure-related adverse events
Tijdsspanne: Procedure-related adverse events will be recorded for 30 days post-procedure.

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.
Procedure-related adverse events will be recorded for 30 days post-procedure.
Postprocedural pain scores
Tijdsspanne: VAS scores will be recorded for 30 days post-procedure

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.
VAS scores will be recorded for 30 days post-procedure
Recovery scores
Tijdsspanne: Assessed 30 days post-procedure

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.
Assessed 30 days post-procedure
Rate of curative local excisions for pT1sm2-3 rectal cancer
Tijdsspanne: Assessed immediately after local excision procedure

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.
Assessed immediately after local excision procedure
Dissection plane evaluation
Tijdsspanne: Assessed immediately after local excision procedure

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.
Assessed immediately after local excision procedure
Quality of local excision specimen
Tijdsspanne: Assessed immediately after local excision procedure

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.
Assessed immediately after local excision procedure
Postoperative adverse events
Tijdsspanne: Assessed for the first 30 days post-operatively

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.
Assessed for the first 30 days post-operatively
TME specimen quality after EID vs TAMIS
Tijdsspanne: Assessed immediately after TME

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).
Assessed immediately after TME
Circumferential resection margin status following completion surgery
Tijdsspanne: Assessed immediately after TME

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.
Assessed immediately after TME
Conversion rate to laparotomy
Tijdsspanne: Assessed immediately after TME

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.
Assessed immediately after TME
Rate of non-restorative TME procedures
Tijdsspanne: Assessed immediately after TME

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.
Assessed immediately after TME
Functional Outcomes
Tijdsspanne: Functional outcomes will be measured via LARS scores within a period of 12 months.

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.
Functional outcomes will be measured via LARS scores within a period of 12 months.
Health related quality of life (QLQ-C30)
Tijdsspanne: Questionnaires will be completed within a period of 3 years.

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.
Questionnaires will be completed within a period of 3 years.
Health related quality of life (QLQ-CR29)
Tijdsspanne: Surveys will be completed within a period of 3 years.

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.
Surveys will be completed within a period of 3 years.
Health related quality of life (EQ-5D-5L)
Tijdsspanne: Surveys will be completed within a period of 3 years.

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.
Surveys will be completed within a period of 3 years.
Rectal preservation and stoma free survival
Tijdsspanne: Following completion of procedure to end of follow-up at 3 years

The use of stoma and rates of rectal preservation will be measured within a 3 year period.
Following completion of procedure to end of follow-up at 3 years
Cancer recurrence rates
Tijdsspanne: Cancer recurrences will be measured over a 3 year follow-up period

Intramural, locoregional, and distant 3-year cancer recurrence rates will be measured.
Cancer recurrences will be measured over a 3 year follow-up period
Survival Rates
Tijdsspanne: Survival will be measured within the 3 year follow-up period.

Three-year disease-specific and overall survival will be measured within the 3 year follow-up period.
Survival will be measured within the 3 year follow-up period.
Healthcare costs
Tijdsspanne: Healthcare costs will be measured from the time of enrollment to the end of the follow-up period at 3 years.

Healthcare costs will be measured using the validated iMCQ and iPCQ questionnaires at 1, 3, 12 and 36 months.
Healthcare costs will be measured from the time of enrollment to the end of the follow-up period at 3 years.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Amsterdam UMC, location VUmc

Medewerkers

ZonMw: The Netherlands Organisation for Health Research and Development

Onderzoekers

  • Hoofdonderzoeker: Barbara Bastiaansen, MD, Amsterdam University Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 maart 2029

Studie voltooiing (Geschat)

1 september 2032

Studieregistratiedata

Eerst ingediend

13 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 september 2026

Eerst geplaatst (Werkelijk)

29 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 september 2026

Laatste update ingediend die voldeed aan QC-criteria

22 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NL-010393

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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