Piecemeal Versus En Bloc Resection of Large Rectal Adenomas

Summary

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

• Colorectal Adenoma With Mild Dysplasia
• Colorectal Adenoma With Severe Dysplasia
• Colorectal Adenomatous Polyp
• Colorectal Low Grade Intraepithelial Neoplasia
• Colorectal High Grade Intraepithelial Neoplasia

Interventions

PROCEDURE

en-bloc resection

En- bloc resection 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.

PROCEDURE

piecemeal resection

Piecemeal resection is done by snare after marking and submucosal injection of saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by snare or forceps. After three months, an APC therapy will follow any piecemeal resection, if necessary, another resection of leftover adenoma will be done.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Thomas Rösch, Prof. Dr. · University Hospital Eppendorf, Hamburg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2021-05-30

Completion

2022-05-30

Countries

• Germany
• United Kingdom

Study Locations