Comparison of laparoscopic and open distal pancreatectomy

ISRCTN	ISRCTN26912858
DOI	https://doi.org/10.1186/ISRCTN26912858
Protocol serial number	N/A
Sponsor	Region Östergötland
Funder	Region Östergötland (Sweden)

Submission date: 28/09/2015
Registration date: 28/09/2015
Last edited: 17/10/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Bergthor Björnsson
Public

Linköping University Hospital
Surgical Department
Linköping
58185
Syria

Study information

Primary study design	Interventional
Study design	Prospective, randomized comparison of laparoscopic vs. open distal pancreatectomy, multicentre
Secondary study design	Randomised controlled trial
Study type	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(s)	Length of stay in hospital after laparoscopic- and open distal pancreatectomy
Key secondary outcome measure(s)	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
Completion date	31/12/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Linköping University Hospital (lead centre)

Linköping
58185
Sweden

Kalmar Hospital

Lasarettsvägen 1
Kalmar
39185
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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?
Results article	results	01/09/2020	08/04/2020	Yes	No
Results article		05/05/2023	17/10/2025	Yes	No
Protocol article	protocol	13/06/2019	17/06/2019	Yes	No
Other publications		07/03/2023	10/03/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/10/2025: Publication reference added.
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.