Condition category
Cancer
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
28/04/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R. Hillegersberg, van

ORCID ID

Contact details

University Medical Center Utrecht (UMCU)
Department of Surgery
G04.228
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 (0)30 2506968
r.vanhillegersberg@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

COCTAIL

Study hypothesis

Continuous positive airway pressure on the deflated lung prevents total alveolar collapse, resulting in less local and systemic cytokine response, causing less pulmonary complications.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Esophageal cancer

Intervention

Continuous Positive Airway Pressure (CPAP) to the collapsed lung during single-lung-ventilation versus no CPAP.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Local and systemic cytokine production.

Secondary outcome measures

1. Pulmonary complications
2. Ventilation time
3. Intensive care unit (ICU) stay
4. Hospital stay

Overall trial start date

05/04/2006

Overall trial end date

05/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with resectable carcinoma of the esophagus or junction that will undergo robot-assisted thoracoscopic esophago-lymphadenectomy with gastric conduit formation
2. American Society of Anesthesiologists (ASA) classification <4
3. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Moderate/severe lung function impairment ascertained by pulmonary function tests, requiring high dose steroid therapy
2. No epidural catheter

Recruitment start date

05/04/2006

Recruitment end date

05/04/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht (UMCU)
Utrecht
3584 CX
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (UMCU), Department of Surgery (The Netherlands)

Sponsor details

Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Comprehensive Cancer Centre (Integraal Kankercentrum)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes