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

2026年9月22日 更新者：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

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

246

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
程序：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.
有源比较器：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.
程序：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Rate of complete R0 resection between TAMIS and EID procedures
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Incidence of procedure-related adverse events
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Amsterdam UMC, location VUmc

合作者

ZonMw: The Netherlands Organisation for Health Research and Development

调查人员

  • 首席研究员：Barbara Bastiaansen, MD、Amsterdam University Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2029年3月1日

研究完成 (估计的)

2032年9月1日

研究注册日期

首次提交

2026年8月13日

首先提交符合 QC 标准的

2026年9月22日

首次发布 (实际的)

2026年9月29日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月22日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NL-010393

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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