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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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20 March 2023 |
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Main ID: |
ISRCTN26912858 |
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Date of registration:
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28/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of laparoscopic and open distal pancreatectomy
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Scientific title:
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RCT-Laparoscopic vs open distal pancreatectomy in an unselected patient cohort |
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Date of first enrolment:
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01/10/2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN26912858 |
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Study type:
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Interventional |
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Study design:
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Prospective, randomized comparison of laparoscopic vs. open distal pancreatectomy, multicentre (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Bergthor
Björnsson |
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Address:
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Linköping University Hospital
Surgical Department
58185
Linköping
Syria |
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Telephone:
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Email:
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Affiliation:
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Name:
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Email:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1.Patients with lesion in the body or tail of the pancreas demanding surgery (indication set by multidisciplinary conference)
2. Operable patient (as the local preoperatively evaluation dictates)
3. Possibility to achieve R0-resection without resection of additional organs (besides the spleen)
4. Patients with performance status 0-2 according to WHO scale
5. Written informed consent.
6. Age > 18 years
Exclusion criteria:
1. Pregnancy and/or lactation
2. Patients being unable to comply with the protocol for reasons of language or cognitive function
3. Preoperatively defined need to resect other organs than pancreas and spleen
4. Preoperatively defined division line of pancreas to the right of the SMV
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pancreatic tumors
Cancer
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Intervention(s)
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Two arms:
1. Laparoscopic distal pancreatectomy
2. Open distal pancreatectomy
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Primary Outcome(s)
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Length of stay in hospital after laparoscopic- and open distal pancreatectomy
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Secondary Outcome(s)
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1. To compare perioperative bleeding during LDP and ODP, measured after operation
2. To compare postoperative pain after LDP and ODP, measured 3 times/day during hospital stay with Visual analouge scale
3. To compare the use of analgetics after LDP and ODP, measured at discharge, amount of drugs given
4. To evaluate quality of life postoperatively after LDP and ODP, measured 5-6 weeks postoperatively as well as 6, 12 and 24 months after operation. Tools for measurement: EORTC QLQ-C30 to which is added the PAN26 module and EQ-5D.
5. To analyze costs associated with LDP and ODP. Measured as direct (hospital cost) after discharge a combination of actual cost and schablon is used
6. To compare complications in LDP and ODP measured up to 90 Days after operation according to Clavien-Dindo classification as well as comprehensive complication index
7. To evaluate survival, measured 2 years after operation
8. Oncological quality of resection measured by PAD assessment as number of investigated lymphnodes and tumor marginal in mm
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Source(s) of Monetary Support
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Region Östergötland (Sweden)
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Ethics review
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Status:
Approval date:
Contact:
Regionala etikprövningsnämnden i Linköping (The regional ethics board for South-east Sweden), ref: 2015/39-31
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2021 |
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URL:
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