An interventional study of Endoscopic Intermuscular Dissection (EID) and Transanal Minimally Invasive Surgery (TAMIS) in Rectal Cancer Stage I, sponsored by Amsterdam UMC, location VUmc. Not yet recruiting at 19 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Treatment
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Among 73 studies in Rectal Neoplasms with a site in Netherlands — 21 open to participants now, 31 under way, 8 of them phase 3. Rectal Neoplasms · Netherlands.
Among the 73 studies in Rectal Neoplasms with a site in Netherlands, this one is the 16th largest by planned enrollment of the 59 interventional ones that give a count, is one of 4 that started in 2026, is one of 16 with no phase, reaches primary completion later than 24 of the 30 other live ones, and was the 73rd registered.
2,402 studies on the registry are indexed under Rectal Neoplasms; 589 are open to participants now.
Browse Rectal Neoplasms studies →21 of the 73 studies in Rectal Neoplasms with a site in Netherlands are open now. Recruiting first, the newest first:
Heike M.U. Peulen · Sites in Netherlands
Ages 18+
Maastricht Radiation Oncology · Sites in Netherlands
Ages 18+
Claudia Schuurhuizen · Sites in Netherlands
Ages 18+
GlaxoSmithKline · Sites in Netherlands, United States, Canada and 6 more countries
Ages 18+
Erasmus Medical Center · Sites in Netherlands
Ages 18+
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 405 Rectal Neoplasms studies recruiting now, 210 (52%) set no upper age limit and 143 (35%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
73 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 21 · Phase 3 21
First in 1993; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 246 is above the median of 65 across 1,753 interventional studies indexed under Rectal Neoplasms.
Median enrollment 108 across the 59 interventional studies, 100 across the 13 observational. Of the 30 that completed or were terminated, 3 (10%) have results posted.
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18 of 73 have an industry lead sponsor. The 10 most frequent:
Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.
Amsterdam UMC, location VUmc has 6 studies filed under Rectal Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies in Rectal Neoplasms with a site in Netherlands that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02945566Phase 3University of BirminghamCan we Save the Rectum by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer? | 2027-08 |
| NCT06607458Delcath Systems Inc.Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease | 2026-12 |
| NCT04927897Maastricht Radiation OncologyDETECT: Target Volume for Rectal Endoluminal Radiation Boosting | 2027-05 |
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Among the 73 studies in Rectal Neoplasms with a site in Netherlands, from their registry updates:
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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:
Participants will:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible to participate in this study, a patient must meet all of the following criteria:
Exclusion criteria:
A patient who meets one or more of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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.
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.
Time frame: Assessed immediately after local excision procedure
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.
Time frame: Procedure-related adverse events will be recorded for 30 days post-procedure.
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.
Time frame: VAS scores will be recorded for 30 days post-procedure
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.
Time frame: Assessed 30 days post-procedure
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.
Time frame: Assessed immediately after local excision procedure
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.
Time frame: Assessed immediately after local excision procedure
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.
Time frame: Assessed immediately after local excision procedure
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.
Time frame: Assessed for the first 30 days post-operatively
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).
Time frame: Assessed immediately after TME
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.
Time frame: Assessed immediately after TME
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.
Time frame: Assessed immediately after TME
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.
Time frame: Assessed immediately after TME
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.
Time frame: Functional outcomes will be measured via LARS scores within a period of 12 months.
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.
Time frame: Questionnaires will be completed within a period of 3 years.
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.
Time frame: Surveys will be completed within a period of 3 years.
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.
Time frame: Surveys will be completed within a period of 3 years.
Rectal preservation and stoma free survival
The use of stoma and rates of rectal preservation will be measured within a 3 year period.
Time frame: Following completion of procedure to end of follow-up at 3 years
Cancer recurrence rates
Intramural, locoregional, and distant 3-year cancer recurrence rates will be measured.
Time frame: Cancer recurrences will be measured over a 3 year follow-up period
Survival Rates
Three-year disease-specific and overall survival will be measured within the 3 year follow-up period.
Time frame: Survival will be measured within the 3 year follow-up period.
Healthcare costs
Healthcare costs will be measured using the validated iMCQ and iPCQ questionnaires at 1, 3, 12 and 36 months.
Time frame: Healthcare costs will be measured from the time of enrollment to the end of the follow-up period at 3 years.
Start is estimated for Sep 2026; primary completion for Mar 2029, 30 months later.
Of 329 non-industry interventional studies with no phase under Rectal Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 78. This study's planned 30 months is below that.
Counting every sponsor, half of 336 studies reached it within 51 months; a quarter within 23 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Amsterdam UMC, location VUmc →