Piecemeal Versus En Bloc Resection of Large Rectal Adenomas (PERLA)
Colorectal Adenoma With Mild Dysplasia, Colorectal Adenoma With Severe Dysplasia, Colorectal Adenomatous Polyp
About this trial
This is an interventional treatment trial for Colorectal Adenoma With Mild Dysplasia focused on measuring piecemeal polypectomy, piecemeal endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), endoscopic en-bloc resection
Eligibility Criteria
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))
Sites / Locations
- Sana Klinikum Lichtenberg
- Vivantes Wenckebach-Klinikum
- University Hospital Eppendorf
- St. Bernward Krankenhaus
- Krankenhaus Barmherzige Brüder Regensburg
- Portsmouth Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
en-bloc resection
piecemeal resection
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.
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.