Piecemeal Versus En Bloc Resection of Large Rectal Adenomas

NCT02238938 | Terminated

• 2 other identifiers: PERLAPV 4580
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 6

Brief 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

Keywords

piecemeal polypectomy; piecemeal endoscopic mucosal resection (EMR); endoscopic submucosal dissection (ESD); endoscopic en-bloc resection

Outcome Measures

Primary Outcomes (1)

• success rate of complete resection

  success rate is confirmed by endoscopical diagnostics as well as histological diagnostics (at lest 6 biopsies in lesions up to 3 cm size, at least 10 biopsies in larger lesions). Patients with no complete resection will be treated further according to clinical requirement, depending on histology.

  6 and 18 months after primary therapy

Secondary Outcomes (8)

• en-bloc group: rate of R0 resections

  timeline 0, day of en-bloc resection

• recurrence rate after complete adenoma resection

  36 months after initial resection

• progress of therapy in patients with incomplete resection and recurrences

  36 months after initial resection

• differences in the subgroups of adenomas

  5 years

• required time for the initial procedure

  timeline 0, day of initial resection

Study Arms (2)

en-bloc resection

EXPERIMENTAL

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.

Procedure: en-bloc resection

piecemeal resection

ACTIVE COMPARATOR

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.

Procedure: piecemeal resection

Interventions

en-bloc resection PROCEDURE

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.

Also known as: endoscopic submucosal dissection, ESD

en-bloc resection

piecemeal resection PROCEDURE

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.

Also known as: piecemeal polypectomy, piecemeal endoscopic mucosal resection, piecemeal EMR

piecemeal resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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))

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (6)

Sana Klinikum Lichtenberg

Berlin, 10365, Germany

Location

Vivantes Wenckebach-Klinikum

Berlin, 12099, Germany

Location

University Hospital Eppendorf

Hamburg, 20246, Germany

Location

St. Bernward Krankenhaus

Hildesheim, 31134, Germany

Location

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, 93049, Germany

Location

Portsmouth Hospitals NHS Trust

Portsmouth, Havant PO9 5NP, United Kingdom

Location

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MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Thomas Rösch, Prof. Dr.

  University Hospital Eppendorf, Hamburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Department of Interdisciplinary Endoscopy

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 12, 2014
• Study Start: April 1, 2014
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2022
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); GB (1)