Condition category
Cancer
Date applied
28/09/2015
Date assigned
28/09/2015
Last edited
28/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Bergthor Björnsson

ORCID ID

Contact details

Linköping University Hospital
Surgical Department
Linköping
58185
Syria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

RCT-Laparoscopic vs open distal pancreatectomy in an unselected patient cohort

Acronym

Study hypothesis

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

Regionala etikprövningsnämnden i Linköping (The regional ethics board for South-east Sweden), ref: 2015/39-31

Study design

Prospective, randomized comparison of laparoscopic vs. open distal pancreatectomy, multicentre

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Pancreatic tumors

Intervention

Two arms:
1. Laparoscopic distal pancreatectomy
2. Open distal pancreatectomy

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2014

Overall trial end date

01/01/2020

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/10/2015

Recruitment end date

01/01/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Linköping University Hospital (lead centre)
Linköping
58185
Sweden

Trial participating centre

Kalmar Hospital
Lasarettsvägen 1
Kalmar
39185
Sweden

Sponsor information

Organisation

Region Östergötland

Sponsor details

Linköping University Hospital
Linköping
58185
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Region Östergötland (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes