Comparison of laparoscopic and open distal pancreatectomy
| ISRCTN | ISRCTN26912858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26912858 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/09/2015
- Registration date
- 28/09/2015
- Last edited
- 10/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The pancreas is a large gland belonging to the digestive system. It produces digestive enzymes (enzymes that break down food) and hormones (for example insulin, the hormone that controls blood sugar levels). Pancreatic cancer is difficult to diagnose in the early stages as symptoms don’t usually occur until the disease is at a more advanced stage. One of the main treatments for pancreatic cancer is surgery, where at least part of the pancreas is removed (resected). This can be done as open surgery (traditional surgery where the patient is opened up at the region where the procedure is to be performed) or laparoscopic (or keyhole) surgery. Laparoscopic surgery allows the surgeon to access a region of the inside of the body without having to make the large incisions (cuts) required in open surgery. The incisions made are much smaller and a laparoscope, a optic cable that allows the surgeon to see inside the body, is used to do the operation. This study investigates whether laparoscopic resection of the left side of the pancreas may result in shorter hospital stay and less bleeding than open procedures.
Who can participate?
Patients that are at least 18 years old diagnosed with diseases in the pancreatic body or tail that needs resection.
What does the study involve?
Particiants are randomly allocated to one of two groups. Those in group 1 have an open distal pancreatectomy. Those in group 2 have a laparoscopic distal pancreatectomy. After surgery, the length of hospital stay for all participants are recorded and comparisons are made as to the amount of bleeding after surgery, pain experienced after surgery, quality of life, any complications, costs involved and whether the participants were still alive two years afterwards.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Linköping University Hospital (lead centre) and Kalmar Hospital (Sweden)
When is study starting and how long is it expected to run for?
January 2014 to January 2020
Who is funding the study?
Region Östergötland (Sweden)
Who is the main contact?
Dr Bergthor Björnsson
Contact information
Public
Linköping University Hospital
Surgical Department
Linköping
58185
Syria
Study information
| Study design | Prospective, randomized comparison of laparoscopic vs. open distal pancreatectomy, multicentre |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | RCT-Laparoscopic vs open distal pancreatectomy in an unselected patient cohort |
| Study objectives | Laparoscopic distal pancreatectomy (LDP) with or without the use of robot, shortens hospital stay and reduces bleeding compared to open distal pancreatectomy (ODP) in unselected patients undergoing distal pancreatectomy with or without splenectomy. |
| Ethics approval(s) | Regionala etikprövningsnämnden i Linköping (The regional ethics board for South-east Sweden), ref: 2015/39-31 |
| Health condition(s) or problem(s) studied | Pancreatic tumors |
| Intervention | Two arms: 1. Laparoscopic distal pancreatectomy 2. Open distal pancreatectomy |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Length of stay in hospital after laparoscopic- and open distal pancreatectomy |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2014 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 18/02/2019 |
Locations
Countries of recruitment
- Sweden
Study participating centres
58185
Sweden
Kalmar
39185
Sweden
Sponsor information
Hospital/treatment centre
Linköping University Hospital
Linköping
58185
Sweden
"ROR" |
https://ror.org/0326gsy75 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Bergthor Björnsson (bergthor@bjornsson@liu.se). Type of data: variables published When the data will become available and for how long: after publication of primary endpoint, unclear how long By what access criteria data will be shared including with whom: shared for the purposes of doing IPDMA For what types of analyses: IPDMA By what mechanism: according to agreement Whether consent from participants was obtained: informed consent (written) was obtained Comments on data anonymisation: all data is anonymous Any ethical or legal restrictions, any other comments: no |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/06/2019 | 17/06/2019 | Yes | No |
| Results article | results | 01/09/2020 | 08/04/2020 | Yes | No |
| Other publications | 07/03/2023 | 10/03/2023 | Yes | No |
Editorial Notes
10/03/2023: Publication reference added.
08/04/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
07/08/2019: The recruitment end date was changed from 31/12/2019 to 18/02/2019, IPD sharing statement added.
17/06/2019: Publication reference added.
15/02/2018: The overall trial end date has been updated from 01/01/2020 to 31/12/2021. The recruitment end date has been updated from 01/01/2018 to 31/12/2019. The intention to publish has added.
