A Study Between Two Instrument Generations to Improve Adenoma Detection in Screening Colonoscopy

June 5, 2019 updated by: Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

A Randomized Comparative Study Between Two Instrument Generations to Improve Adenoma Detection in Screening Colonoscopy

Adenoma detection rate (ADR) is the most important parameter to measure outcome quality of (screening) colonoscopy. Since single improvements of imaging have not been able to improve ADR in many randomized studies, the present study tested the hypothesis that only multiple imaging improvements such as seen with two generation changes of colonoscopies - i.e. skipping one colonoscope generation - may be necessary before improvements in ADR can be measured.

The investigators will test this hypothesis in the present randomized tandem study in 7 private practices in Hamburg and Berlin, in a pure screening colonoscopy setting, aiming at inclusion of 1200 patients > age of 55 years (screening colonoscopy cut-off in Germany). Exclusion criteria are symptomatic patients and colonoscopies planned for therapeutic reasons. Main outcome parameter is the ADR (rate of patients with at least one adenoma/all patients).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was a prospective multicenter randomized study involving 7 private practice gastroenterology offices with a total of 14 experienced examiners (> 2000 colonoscopies), performed between November 2013 and September 2016 (sets of instruments were made available to 3-4 centers each during 6-12 months).Study population:

Patients were selected from the screening colonoscopy list (age ≥ 55 years), with further inclusion criteria being status 1 and 2 of the ASA classification. After informed consent, patients were randomized using sealed envelopes per center to one of either of the two study groups

  1. 190 C group (intervention group), examination with the latest generation colonoscope (190 series CF or PCF colonoscopies, Olympus Corp, Hamburg, Germany).
  2. 165 C group (control group), examination with the 160/5 generation colonoscope (Olympus Corp, Hamburg, Germany), Each patient underwent bowel preparation in accordance with local practice of the centers. Bowel cleansing quality was segmentally assessed using a modified overall "Boston Bowel Preparation Scale". Introduction and withdrawal times were measured, and times required for biopsies and polypectomies were considered separately, i.e. overall and diagnostic only withdrawal times were recorded separately.

Polyps were documented with regards to location (caecum, ascending, transverse and descending colon, sigmoid and rectum), size and morphology using the Paris classification (polypoid pedunculated or sessile, non-polypoid slightly elevated/flat/depressed, ulcerous). Polyps were then resected using biopsy forceps or cold snare or conventional polypectomy according to local standards. Histology of resected polyps was analyzed by local private practice specialized GI pathologists according to the Vienna classification with regards to dysplasia grade and the presence of serrated adenomas; final histologic categories were hyperplastic, adenomatous [tubulous, villous, tubulovillous, serrated (traditional or sessile serrated)]. Small distal rectal polyps were not systematically biopsied or resected, due to a very high likelihood to be hyperplastic.

Study Type

Observational

Enrollment (Actual)

1221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10713
        • Gemeinschaftspraxis Hohenzollerndamm
      • Berlin, Germany, 10825
        • Gastroenterologie am Bayerischen Platz
      • Berlin, Germany, 12163
        • Praxis Mayr / Heller
      • Berlin, Germany, 13437
        • Dr. Alireza Aminalai
      • Berlin, Germany, 13581
        • Dr. Jens Aschenbeck
      • Hamburg, Germany, 20246
        • Gastropraxis Eppendorferbaum
      • Hamburg, Germany, 20354
        • Gastroenterologie-Fontanay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged 55 years and above, planned for a screening colonoscopy in one of the parttaking private practices.

Description

Inclusion Criteria:

  • screening colonoscopy, age ≥ 55 years
  • status 1 and 2 of the ASA classification
  • signed informed consent

Exclusion Criteria:

  • Symptoms indicative of colorectal disease such as colonic bleeding, significant diarrhea, obstipation and change in bowel habits
  • Known colonic disease for further evaluation (e.g. inflammatory bowel disease, polyps for resection)
  • Surveillance after polypectomy or colon tumor surgery
  • Anticoagulants preventing biopsy or polypectomy
  • Poor general condition (ASA III or more)
  • Incomplete colonoscopy planned

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Olympus 190
Olympus colonoscope 190 C (intervention group), screening colonoscopy examination with the latest generation colonoscope (190 series CF or PCF colonoscopies, Olympus Corp, Hamburg, Germany).
Procedure: screening colonoscopy

Introduction and forwarding of the device up to caecum/terminal ileum. Then withdrawal and inspection of colonic wall. Biopsies and polypectomies if necessary. overall and diagnostic (only withdrawal) times being recorded separately.

Polyps are documented with regards to location (caecum, ascending, transverse and descending colon, sigmoid and rectum), size (open forceps or snare for comparison) and morphology using the Paris classification (polypoid pedunculated or sessile, non-polypoid slightly elevated/flat/depressed, ulcerous) Polyps were then resected using biopsy forceps or cold snare (for polyps < 5 mm), or conventional polypectomy according to local standards.
Olympus 160/165
Olympus colonoscope 165 C (control group), screening colonoscopy examination with the 160/5 generation colonoscope (Olympus Corp, Hamburg, Germany),
Procedure: screening colonoscopy

Introduction and forwarding of the device up to caecum/terminal ileum. Then withdrawal and inspection of colonic wall. Biopsies and polypectomies if necessary. overall and diagnostic (only withdrawal) times being recorded separately.

Polyps are documented with regards to location (caecum, ascending, transverse and descending colon, sigmoid and rectum), size (open forceps or snare for comparison) and morphology using the Paris classification (polypoid pedunculated or sessile, non-polypoid slightly elevated/flat/depressed, ulcerous) Polyps were then resected using biopsy forceps or cold snare (for polyps < 5 mm), or conventional polypectomy according to local standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: day 1
adenoma detection rate (ADR) of 190 colonoscopes in comparison to 160/5 colonoscopes at the patient level (% of patients with at least one adenoma).
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma rate
Time Frame: through study completion, an average of 6 months
Adenoma rate calculated at the adenoma level (all adenomas/all patients) and as the number of adenomas per adenoma carrier.
through study completion, an average of 6 months
Adenoma subgroups: size
Time Frame: through study completion, an average of 6 months
Adenoma subgroups due to size (< 1 cm, > 1 cm)
through study completion, an average of 6 months
Adenoma subgroups: form
Time Frame: through study completion, an average of 6 months
Adenoma subgroups due to form (flat, sessile, pedunculated)
through study completion, an average of 6 months
Adenoma subgroups: location
Time Frame: through study completion, an average of 6 months
Adenoma subgroups due to location (right sided - down to left hepatic flexure, left sided - descending colon, sigmoid and rectum)
through study completion, an average of 6 months
Adenoma subgroups: histology
Time Frame: through study completion, an average of 6 months
Adenoma subgroups due to histologic subgroups (SSA, HGIN)
through study completion, an average of 6 months
Cecal intubation rate
Time Frame: through study completion, an average of 6 months
Cecal intubation rate per arm, all patients
through study completion, an average of 6 months
complication rate
Time Frame: through study completion, an average of 6 months
Complications in both groups
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Thomas Rösch, Prof. Dr., University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV4343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no individual participant data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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