Endoscopic (EID) Versus Surgical (TAMIS) Local Excision for Early Stage Rectal Cancer (ENSURE)
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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Elena A Kasantsidis, MD
- 전화번호: +31 651768033
- 이메일: e.a.kasantsidis@amsterdamumc.nl
연구 장소
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Alkmaar, 네덜란드
- NoordWest Ziekenhuisgroep
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연락하다:
- Wing Liu
- 전화번호: +31 72 - 548 3324
- 이메일: w.s.liu@nwz.nl
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수석 연구원:
- Mich Dunker, MD PhD
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Almere Stad, 네덜란드
- Flevoziekenhuis
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연락하다:
- Krista Lam
- 전화번호: +31 36 868 86 16
- 이메일: krlam@flevoziekenhuis.nl
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수석 연구원:
- Anthony van de Ven, MD
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Amersfoort, 네덜란드, 3813 TZ
- Meander Medisch Centrum
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연락하다:
- Nienke Hennequin
- 전화번호: +31 33 8505050
- 이메일: nl.hennequin@meandermc.nl
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수석 연구원:
- Esther Consten, MD PhD
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Amsterdam, 네덜란드
- OLVG
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연락하다:
- Simone Röttgering
- 전화번호: +31 20 510 87 77
- 이메일: s.rottgering@olvg.nl
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수석 연구원:
- Michael Gerhards, MD PhD
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Amsterdam, 네덜란드, 1081 HV
- Amsterdam UMC
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연락하다:
- Elena A Kasantsidis, MD
- 전화번호: +31 651768033
- 이메일: ENSURE@amsterdamumc.nl
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부수사관:
- Elena Kasantsidis, MD
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수석 연구원:
- Barbara Bastiaansen, MD
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Amsterdam, 네덜란드
- Antoni Van Leeuwenhoek
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연락하다:
- Yanaika Tankink
- 전화번호: +31 020 512 9111
- 이메일: y.tankink@nki.nl
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수석 연구원:
- Brechtje Grotenhuis, MD PhD
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Capelle aan den IJssel, 네덜란드
- Ijsselland Ziekenhuis
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연락하다:
- Sita Willigen
- 전화번호: +31 102585180
- 이메일: swilligen@ysl.nl
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수석 연구원:
- Pascal Doornebosch, MD
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Deventer, 네덜란드
- Deventer Ziekenhuis
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연락하다:
- Alinda Guitink
- 전화번호: +31 (570) 53 51 05
- 이메일: a.guitink@dz.nl
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수석 연구원:
- Frank ter Borg, MD
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Eindhoven, 네덜란드
- Catharina Ziekenhuis
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연락하다:
- Monique Monique van Dillen - Schilders
- 전화번호: +31 402399750
- 이메일: researchmdl@catharinaziekenhuis.nl
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수석 연구원:
- Ramon Michel Schreuder, MD
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Groningen, 네덜란드, 9713 GZ
- Universitair Medisch Centrum Groningen
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연락하다:
- Annika Dommering-Blankenstein
- 전화번호: +31 (050) 361 92 59
- 이메일: j.f.blankenstein@umcg.nl
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연락하다:
- Wieke Holwerda
- 이메일: w.holwerda@umcg.nl
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수석 연구원:
- Wouter Nagengast, MD PhD
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Haarlem, 네덜란드
- Spaarne Gasthuis
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Hoorn, 네덜란드
- Dijklander Ziekenhuis
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연락하다:
- Maisha van der Zon
- 전화번호: +31 229257823
- 이메일: DOC@dijklander.nl
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수석 연구원:
- Joris van den Broek, MD
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Leiden, 네덜란드
- Leiden Universitair Medisch Centrum
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연락하다:
- Jurjen Boonstra, MD PhD
- 전화번호: +31 71 526 35 75
- 이메일: j.j.boonstra@lumc.nl
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수석 연구원:
- Jurjen Boonstra, MD PhD
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Nieuwegein, 네덜란드
- St. Antonius Ziekenhuis
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Roermond, 네덜란드
- Laurentius Ziekenhuis
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연락하다:
- Annette Meijer
- 전화번호: +31(475) 38 27 68
- 이메일: annette.meijer@lzr.nl
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수석 연구원:
- Jeroen Leijtens, MD
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Rotterdam, 네덜란드, 3015 GD
- Erasmus Medisch Centrum
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연락하다:
- Milko van Langen
- 전화번호: +31 107040572
- 이메일: m.vanlangen@erasmusmc.nl
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수석 연구원:
- Arjun Koch, MD PhD
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The Hague, 네덜란드
- Haaglanden Medisch Centrum
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연락하다:
- Angela van Egmond
- 전화번호: +31 88 979 43 07
- 이메일: angela.van.egmond@haaglandenmc.nl
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수석 연구원:
- Andreas Marinelli, MD PhD
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Utrecht, 네덜란드, 3584 CX
- University Medical Center Utrecht
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연락하다:
- Linda Wissenlink
- 전화번호: +31 088 75 56276
- 이메일: l.e.wisselink@umcutrecht.nl
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수석 연구원:
- Leon Moons, MD PhD
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Zwolle, 네덜란드
- Isala
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연락하다:
- Lieke Smeets
- 전화번호: +31 88 624 62 23
- 이메일: research.chirurgie@isala.nl
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수석 연구원:
- Erik van Westreenen, MD PhD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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. |
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. |
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활성 비교기: 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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of complete R0 resection between TAMIS and EID procedures
기간: Assessed immediately after local excision procedure
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of procedure-related adverse events
기간: 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.
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Postprocedural pain scores
기간: VAS scores will be recorded for 30 days post-procedure
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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
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Recovery scores
기간: Assessed 30 days post-procedure
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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
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Rate of curative local excisions for pT1sm2-3 rectal cancer
기간: Assessed immediately after local excision procedure
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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
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Dissection plane evaluation
기간: Assessed immediately after local excision procedure
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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
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Quality of local excision specimen
기간: Assessed immediately after local excision procedure
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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
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Postoperative adverse events
기간: Assessed for the first 30 days post-operatively
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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
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TME specimen quality after EID vs TAMIS
기간: Assessed immediately after TME
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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
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Circumferential resection margin status following completion surgery
기간: Assessed immediately after TME
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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
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Conversion rate to laparotomy
기간: Assessed immediately after TME
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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
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Rate of non-restorative TME procedures
기간: 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
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Functional Outcomes
기간: Functional outcomes will be measured via LARS scores within a period of 12 months.
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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.
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Health related quality of life (QLQ-C30)
기간: 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.
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Health related quality of life (QLQ-CR29)
기간: Surveys will be completed within a period of 3 years.
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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.
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Health related quality of life (EQ-5D-5L)
기간: Surveys will be completed within a period of 3 years.
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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.
|
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Rectal preservation and stoma free survival
기간: Following completion of procedure to end of follow-up at 3 years
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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
|
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Cancer recurrence rates
기간: 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
|
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Survival Rates
기간: 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.
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Healthcare costs
기간: Healthcare costs will be measured from the time of enrollment to the end of the follow-up period at 3 years.
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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.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Barbara Bastiaansen, MD, Amsterdam University Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- NL-010393
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .