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Piecemeal Versus En Bloc Resection of Large Rectal Adenomas (PERLA)

Primary Purpose

Colorectal Adenoma With Mild Dysplasia, Colorectal Adenoma With Severe Dysplasia, Colorectal Adenomatous Polyp

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
en-bloc resection
piecemeal resection
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

en-bloc resection

piecemeal resection

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

en-bloc group: rate of R0 resections
This parameter is regarding histopathology. Since piecemeal resections do not allow such a diagnosis, this parameter is only for the en-bloc resected group.
recurrence rate after complete adenoma resection
Since early recurrences can evolve from leftover tumor cells and will become manifest after a time, the third control after two controls with negative biopsies.has been chosen to be the gold standard.
progress of therapy in patients with incomplete resection and recurrences
patients will be treated further according to treatment standard depending on endoscopical and histological findings
differences in the subgroups of adenomas
size, shape according to nice classification, low-grade and high grade intraepithelial adenomas, sm1 carcinomas
required time for the initial procedure
for piecemeal resections including second procedure with APC therapy
complications including success of complication management
rate of complications that need intervention, e.g. perforation (intra - and post procedural, surgery, additional procedures such as antibiotics, monitoring, intensive care secondary haemorrhage (second look endoscopy, surgery) infection
complications through patient sedation
depending on sedation standards of the participating centers
resolution of tumor board for post resections and outcomes of patients with carcinoma histology
patients with carcinoma histology will be discussed by a of tumor board

Full Information

First Posted
September 4, 2014
Last Updated
June 27, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT02238938
Brief Title
Piecemeal Versus En Bloc Resection of Large Rectal Adenomas
Acronym
PERLA
Official Title
Piecemeal Versus En Bloc Resection of Large Rectal Adenomas -A Prospective, Randomized Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitment of study patients
Study Start Date
April 2014 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In 20 to 35% of colonoscopies due to symptoms or for prevention polyps, so-called adenoma, are found. Currently, colonoscopy is the best way to detect bowel tumors and polyps, since these can be biopsied and removed in one working process. If the size of adenoma is larger than 2 cm, resections are usually done in a hospital setting. Foremost for flat adenoma, the resection by snares piece by piece, the so-called piecemeal polypectomy, or piecemeal endoscopic mucosal resection (EMR), is state of the art. Resection will usually follow a submucosal saline injection (saline assisted polypectomy). Recurrences occur in 10 up to 25 %, requiring a reapplication of endoscopic therapy and follow up examinations. Depending on the size of adenoma, increasing amounts of cell alterations of an advanced stage such as high grade dysplasia / intraepithelial neoplasia (HGIN) up to early cancer are found. In these cases, for histo-pathological and oncological reasons, a resection in a solitary manner (en-bloc resection) is necessary to evaluate the completeness of resection properly. Also, former studies showed that recurrence rate could be decreased considerably by en-bloc resections, since the aim is to perform a complete resection basally and laterally. New endoscopic techniques of en-bloc resections have been introduced since a couple of years, using several endoscopic knifes to cut adenoma down after submucosal injection of liquid and consecutively dissect it from the tissue underneath. This technique is mostly called endoscopic submucosal dissection (ESD), and, with not too large adenoma, can be combined with snare resection, too. The complexity of this method though is much larger than that of snare resection. Therefore, the western success rate is considerably less than in Japan, where it was developed first, and where higher numbers of cases exist in the upper GI tract as well as in the lower GI tract. All in all, the complication rate of en-bloc resection is higher than that of snare resection. Those complications, mostly perforations, are endoscopically controllable in most cases, though. In comparison with Japan, Korea or China, early malign lesions oft he upper GI tract in the West are rare. Therefore, this study will be conducted on (colo)rectal lesions, which appear much more often in the West. All in all, for efficacy (resection in total, number of recurrences) and risk (perforations), there is an indistinct data situation between piecemeal resection (EMR) and en-bloc resection (ESD). Up to now, no randomised comparing data exist. The planned study is the first randomised study between ESD and piecemeal EMR at all, since there are no studies been done for the upper GI tract, either. For reasons of complexity, ESD will conceivably remain a method for specialized centers, while piecemeal polypectomies are done in numerous hospitals. Therefore, the outcomes of this study will have influence on future logistics in polypectomies and flow of patients with large colorectal adenoma. 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 Argon plasma coagulation (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. 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. Follow-up care: sigmoidoscopy after 6 and 18 months, colonoscopy after 36 months each after the end of the primary therapy session(s). Diagnostics will be done endoscopically and histologically of at least 6 biopsies if the size of lesion was up to 3 cm, and of at least 10 biopsies for larger lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
en-bloc resection
Arm Type
Experimental
Arm 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.
Arm Title
piecemeal resection
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
en-bloc resection
Other Intervention Name(s)
endoscopic submucosal dissection, ESD
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
piecemeal resection
Other Intervention Name(s)
piecemeal polypectomy, piecemeal endoscopic mucosal resection, piecemeal EMR
Intervention Description
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.
Primary Outcome Measure Information:
Title
success rate of complete resection
Description
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.
Time Frame
6 and 18 months after primary therapy
Secondary Outcome Measure Information:
Title
en-bloc group: rate of R0 resections
Description
This parameter is regarding histopathology. Since piecemeal resections do not allow such a diagnosis, this parameter is only for the en-bloc resected group.
Time Frame
timeline 0, day of en-bloc resection
Title
recurrence rate after complete adenoma resection
Description
Since early recurrences can evolve from leftover tumor cells and will become manifest after a time, the third control after two controls with negative biopsies.has been chosen to be the gold standard.
Time Frame
36 months after initial resection
Title
progress of therapy in patients with incomplete resection and recurrences
Description
patients will be treated further according to treatment standard depending on endoscopical and histological findings
Time Frame
36 months after initial resection
Title
differences in the subgroups of adenomas
Description
size, shape according to nice classification, low-grade and high grade intraepithelial adenomas, sm1 carcinomas
Time Frame
5 years
Title
required time for the initial procedure
Description
for piecemeal resections including second procedure with APC therapy
Time Frame
timeline 0, day of initial resection
Title
complications including success of complication management
Description
rate of complications that need intervention, e.g. perforation (intra - and post procedural, surgery, additional procedures such as antibiotics, monitoring, intensive care secondary haemorrhage (second look endoscopy, surgery) infection
Time Frame
5 years
Title
complications through patient sedation
Description
depending on sedation standards of the participating centers
Time Frame
timeline 0, day of initial resection
Title
resolution of tumor board for post resections and outcomes of patients with carcinoma histology
Description
patients with carcinoma histology will be discussed by a of tumor board
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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))
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Rösch, Prof. Dr.
Organizational Affiliation
University Hospital Eppendorf, Hamburg
Official's Role
Study Chair
Facility Information:
Facility Name
Sana Klinikum Lichtenberg
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Vivantes Wenckebach-Klinikum
City
Berlin
ZIP/Postal Code
12099
Country
Germany
Facility Name
University Hospital Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
St. Bernward Krankenhaus
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Krankenhaus Barmherzige Brüder Regensburg
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
ZIP/Postal Code
Havant PO9 5NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
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Piecemeal Versus En Bloc Resection of Large Rectal Adenomas

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