Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001402336
Ethics application status
Approved
Date submitted
22/09/2017
Date registered
4/10/2017
Date last updated
4/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cytokine response in the pleural fluid and blood in minimal-invasive and open esophagectomy
Scientific title
Cytokine response in the pleural fluid and blood in minimal-invasive and open esophagectomy
Secondary ID [1] 292960 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oesophageal cancer
 304858 0
Condition category
Condition code
Cancer 304163 304163 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open esophagectomy. Informed consent is provided describing risk and benefits of the procedure. All open procedures are performed by experienced oesophageal and upper GI surgeons. The Duration of the procedure is 120-240 minutes. Patients are surveilled on the intensive care unit postoperatively. Open esophagectomy involves thoracotomy and laparotomy. After esophageal resection, reconstruction and anastomosis is performed using the remnant stomach.
Intervention code [1] 299197 0
Treatment: Surgery
Comparator / control treatment
Minimal invasive (laparoscopic and thoracosopic) esophagecotmy. Informed consent is provided describing risk and benefits of the procedure. All minimal invasive procedures are performed by experienced oesophageal and upper GI surgeons. The Duration of the procedure is 120-240 minutes. Esophagectomy and Reconstruction are performed with minimal invasive approach such as laparoscopic and thoracoscopic. Patients are surveilled on the intensive care unit postoperatively.


Control group
Active

Outcomes
Primary outcome [1] 303477 0
Composite Primary outcome: cytokine Response (IL)-6 and IL-8, the anti-inflammatory IL-1 RA and the chemokines CINC-1 and MCP-1.Blood specimens were collected from intravenous or arterial lines that were routinely in place. Concentrations of IL-6, IL-8, IL-1RA, CINC-1 and MCP-1 in the blood and the collected pleural fluid were analyzed using enzyme-linked immune-sorbent assays (ELISA, R & D Systems, Minneapolis, MN, USA).
Timepoint [1] 303477 0
Baseline, end of surgery, 24 hours (Primary outcome), 48 hours and 72 hours postoperatively.
Secondary outcome [1] 339036 0
complications such as leaks, abscess, cardiac or pulmonary complications. clinical and Imaging assessemnt
Timepoint [1] 339036 0
early postoperative phase (1 to 29 days postoperatively) and late postoperative phase(30 days to last clinical consult 1 year postoperatively),

Eligibility
Key inclusion criteria
patients eligible for Operation, oesphageal cancer requiring surgery, aged over 18 years, able to sign in for informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not fit for operation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The allocation was not randomized, but followed the individual surgeon’s preference for one or the other technique.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
prospective inclusion of 12 patients per Group, no power calculation

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
1/09/2012
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 297586 0
Hospital
Name [1] 297586 0
Flinders Medical Centre
Country [1] 297586 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Bedford Park SA 5042, Australia
Country
Australia
Secondary sponsor category [1] 296599 0
None
Name [1] 296599 0
Address [1] 296599 0
Country [1] 296599 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298677 0
FLINDERS CLINICAL RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 298677 0
Southern Adelaide Clinical Human Research Ethics Committee, Flinders Dr1, Bedford Park SA 5042, Australia
Ethics committee country [1] 298677 0
Australia
Date submitted for ethics approval [1] 298677 0
Approval date [1] 298677 0
31/12/2008
Ethics approval number [1] 298677 0

Summary
Brief summary
To investigate cytokine Response in the blood and pleural fluid in laparoscopic versus open esophagectomy in esophageal cancer. Prospective non randomised Trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77862 0
Mr Urs Zingg
Address 77862 0
Spital Limmattal, PD Dr. med. Urs Zingg, Urdorferstrasse 38. 8952 Schlieren, Switzerland
Country 77862 0
Switzerland
Phone 77862 0
+41 44 733 24 05
Fax 77862 0
Email 77862 0
Sekretariat.chirurgie@spital-limmattal.ch
Contact person for public queries
Name 77863 0
Tarik Delko
Address 77863 0
Unispital Basel, Spitalstrassse 21, 4031 Basel, Switzerland
Country 77863 0
Switzerland
Phone 77863 0
+41 76 910 30 21
Fax 77863 0
Email 77863 0
tarik.delko@usb.ch
Contact person for scientific queries
Name 77864 0
tarik delko
Address 77864 0
Unispital Basel, spitalstrasse 21, 4031 Basel, Switzerland,
Country 77864 0
Switzerland
Phone 77864 0
+41 76 910 30 21
Fax 77864 0
Email 77864 0
tarik.delko@usb.ch

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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