Clinical trial · Interventional
Piecemeal Versus En Bloc Resection of Large Rectal Adenomas
Piecemeal Versus En Bloc Resection of Large Rectal Adenomas -A Prospective, Randomized Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient recruitment of study patients
Summary
Brief summary (as posted)
Currently, colonoscopy is the safest way to detect bowel tumors and polyps, since these can be biopsied and removed in one working process. If the size of adenomas is larger than 2 cm, resections are usually done in a hospital setting. For the resection of large adenomas, different approaches can be used. The so-called piecemeal resection is done with snares, to cut off parts of the adenoma piece by piece until the whole adenoma is resected. This technique is the standard therapy, but is not required for very large adenomas, which can often show cell alterations that indicate cancer. Therefore these adenomas should be resected in one piece. This is done by the so-called en-bloc resection. For this kind of therapy, different endoscopic knifes are use to cut off the adenoma as a whole. Both resection techniques are done usually by previous injection of saline or other liquids to elevate the lesion from its bottom tissue. Although the piecemeal resection of large adenoma is the standard therapy, it shows recurrence rates of 10 to 25%, which afford repeated therapies and follow up controls. En-bloc resections, though, are expected to have less recurrence rates but are much more complex to perform. They have higher complication rates especially in the West, where it has bee introduced only a couple of years ago. The data situation regarding safety and efficacy of both therapies is low. This study is the first one ever to compare piecemeal EMR and ESD in a randomized way. The study might have influence on the logistics of future adenoma processing and patient flow.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenomatous Polyp | Colorectal Adenomatous Polyp | ONTOLOGY_EXACT | 0.98 |
| Colorectal Adenoma With Mild Dysplasia | — | UNRESOLVED | — |
| Colorectal Adenoma With Severe Dysplasia | Colorectal Conventional Adenoma with Severe Dysplasia | ALIAS | 0.90 |
| Colorectal High Grade Intraepithelial Neoplasia | Colorectal High Grade Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Colorectal Low Grade Intraepithelial Neoplasia | Colorectal Low Grade Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| en-bloc resection | Procedure | — | UNRESOLVED |
| piecemeal resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- en-bloc resection
- description
- En- bloc resection is done after marking by use of different customary endoscopic knifes including combining devices as hybrid knife to cut down the lesion. After submucosal injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and removed by a snare of adequate size solitarily. Since the aim of this method is the total resection basally and laterally, only one session is intended.
- interventionNames
- Procedure: en-bloc resection
- type
- ACTIVE_COMPARATOR
- label
- piecemeal resection
- description
- Piecemeal resection will be done by snare following marking and submucosal injection of saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by snare or forceps. High resolution endoscopes are mandatory. After three months, an APC therapy will follow any piecemeal resection, if necessary, another resection of leftover adenoma will be done. This second session can be done by sigmoidoscopy.
- interventionNames
- Procedure: piecemeal resection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with large non pedunculated colorectal adenomas designated for endoscopic resection up to 15 cm ab ano, length 2 cm to 5 cm, maximum hemicircumferential * age \> 18 years * signed Informed Consent Exclusion Criteria: * adenomas smaller or larger than described above * more than one large rectal adenoma * adenomas with known or suspected carcinoma, proven by previous biopsies * adenomas with known or suspected carcinoma that do not seem to be resectable by endoscopy, e.g. ulcers, suspected infiltration of submucosa after endoscopic or ultrasound diagnostics * patients with chronic inflammatory bowel diseases * severe general disease, including metastasising carcinomas * coagulation abnormalities or anticoagulant drug use which make resection therapy impossible * bad general state of health (American Society of Anesthesiologists Classification (ASA) IV or more) * pregnancy and lactation * recurrence or leftover dysplasia after extended endoscopic or surgical therapy (transanal endoscopic microsurgery (TEM))
References
Publications (34)
- BACKGROUNDRisio M. The natural history of colorectal adenomas and early cancer. Pathologe. 2012 Nov;33 Suppl 2:206-10. doi: 10.1007/s00292-012-1640-6. PMID 22945585
- BACKGROUNDLieberman DA, Weiss DG, Harford WV, Ahnen DJ, Provenzale D, Sontag SJ, Schnell TG, Chejfec G, Campbell DR, Kidao J, Bond JH, Nelson DB, Triadafilopoulos G, Ramirez FC, Collins JF, Johnston TK, McQuaid KR, Garewal H, Sampliner RE, Esquivel R, Robertson D. Five-year colon surveillance after screening colonoscopy. Gastroenterology. 2007 Oct;133(4):1077-85. doi: 10.1053/j.gastro.2007.07.006. PMID 17698067
- BACKGROUNDSaini SD, Kim HM, Schoenfeld P. Incidence of advanced adenomas at surveillance colonoscopy in patients with a personal history of colon adenomas: a meta-analysis and systematic review. Gastrointest Endosc. 2006 Oct;64(4):614-26. doi: 10.1016/j.gie.2006.06.057. PMID 16996358
- BACKGROUNDStegeman I, de Wijkerslooth TR, Stoop EM, van Leerdam ME, Dekker E, van Ballegooijen M, Kuipers EJ, Fockens P, Kraaijenhagen RA, Bossuyt PM. Colorectal cancer risk factors in the detection of advanced adenoma and colorectal cancer. Cancer Epidemiol. 2013 Jun;37(3):278-83. doi: 10.1016/j.canep.2013.02.004. Epub 2013 Mar 9. PMID 23491770
- BACKGROUNDvan Heijningen EM, Lansdorp-Vogelaar I, Kuipers EJ, Dekker E, Lesterhuis W, Ter Borg F, Vecht J, De Jonge V, Spoelstra P, Engels L, Bolwerk CJ, Timmer R, Kleibeuker JH, Koornstra JJ, van Ballegooijen M, Steyerberg EW. Features of adenoma and colonoscopy associated with recurrent colorectal neoplasia based on a large community-based study. Gastroenterology. 2013 Jun;144(7):1410-8. doi: 10.1053/j.gastro.2013.03.002. Epub 2013 Mar 7. PMID 23499951
- BACKGROUNDJang JH, Balik E, Kirchoff D, Tromp W, Kumar A, Grieco M, Feingold DL, Cekic V, Njoh L, Whelan RL. Oncologic colorectal resection, not advanced endoscopic polypectomy, is the best treatment for large dysplastic adenomas. J Gastrointest Surg. 2012 Jan;16(1):165-71; discussion 171-2. doi: 10.1007/s11605-011-1746-9. Epub 2011 Nov 5.