Endoscopic Intermuscular Dissection Versus Transanal Minimally Invasive Surgery for Local Excision of Early Rectal Cancer: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 246
- 试验地点
- 19
- 主要终点
- Rate of complete R0 resection between TAMIS and EID procedures
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Endoscopic Intermuscular Dissection (EID) (Procedure)
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.
干预措施: Transanal Minimally Invasive Surgery (TAMIS) (Procedure)
结局指标
主要结局
Rate of complete R0 resection between TAMIS and EID procedures
时间窗: 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.
次要结局
- 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)
- Quality of local excision specimen(Assessed immediately after local excision procedure)
- Postoperative adverse events(Assessed for the first 30 days post-operatively)
- TME specimen quality after EID vs TAMIS(Assessed immediately after TME)
- Circumferential resection margin status following completion surgery(Assessed immediately after TME)
- Conversion rate to laparotomy(Assessed immediately after TME)
- Rate of non-restorative TME procedures(Assessed immediately after TME)
- Functional Outcomes(Functional outcomes will be measured via LARS scores within a period of 12 months.)
- Health related quality of life (QLQ-C30)(Questionnaires will be completed within a period of 3 years.)
- Health related quality of life (QLQ-CR29)(Surveys will be completed within a period of 3 years.)
- Health related quality of life (EQ-5D-5L)(Surveys will be completed within a period of 3 years.)
- Rectal preservation and stoma free survival(Following completion of procedure to end of follow-up at 3 years)
- Cancer recurrence rates(Cancer recurrences will be measured over a 3 year follow-up period)
- Survival Rates(Survival will be measured within the 3 year follow-up period.)
- Healthcare costs(Healthcare costs will be measured from the time of enrollment to the end of the follow-up period at 3 years.)
研究者
Barbara Bastiaansen
Gastroenterologist
Amsterdam UMC, location VUmc