Plain English Summary
Background and study aims
A pancreaticoduodenectomy is a surgical procedure performed to treat pancreatic cancer. It typically involves removing the head of the pancreas, a portion of the duodenum (first part of the small intestine) and other organs. Although many procedures are routinely performed via keyhole (laparoscopic) surgery, pure laparoscopic pancreaticoduodenectomy (LPD) is not because of the technical difficulty in removing the head of the pancreas (pancreatic resection) and the following reconstruction procedures. Here, we want to present a novel easy reconstruction technique and it's safety.
Who can participate?
Patients requiring laparoscopic pancreaticoduodenectomy who agree to be treated with the new technique.
What does the study involve?
A new laparoscopic reconstruction technique is performed on five participants undergoing a pancreaticoduodenectomy.
What are the possible benefits and risks of participating?
There are no benefit or risks associated with taking part in the trial.
Where is the study run from?
Toranomon Hospital (Japan)
When is the study starting and how long is it expected to run for?
January 2012 to December 2013
Who is funding the study?
Toranomon Hospital research committee (Japan)
Who is the main contact?
Dr Kazunari Sasaki
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Pancreaticogastrostomy in pure laparoscopic pancreaticoduodenectomy - a novel pancreatic-gastric anastomosis technique
Acronym
Study hypothesis
To validate new technique safety
Ethics approval(s)
Human ethical committee of Toranomon hospital
Study design
Single center prospective
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Pancreas or papillar of Vater tumor requiring pancreaticoduodenectomy
Intervention
We tested the operative method safety and reproducibility of our new laparoscopic reconstruction technique.
Duration of observation was 7.7–15.5 months. (total duration of observation and follow-up are the same)
Intervention type
Procedure/Surgery
Primary outcome measure
Mortality and morbidity.
We evaluated outcome from just after operation to most recent outpatient clinic visit.
Secondary outcome measures
N/A
Overall study start date
01/01/2012
Overall study end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients requiring laparoscopic pancreaticoduodenectomy who agree with using the new technique
Participant type(s)
Other
Age group
All
Sex
Both
Target number of participants
5
Participant exclusion criteria
N/A
Recruitment start date
01/01/2012
Recruitment end date
31/12/2013
Locations
Countries of recruitment
Japan
Study participating centre
Toranomon Hospital
2-2-2 Toranomon Minato-ku
Tokyo
105-8470
Japan
Sponsor information
Organisation
Toranomon Hospital
Sponsor details
2-2-2 Toranomon Minato-ku
Tokyo
105-8470
Japan
+81-3-3588-1111
sasakikazunari1978@hotmail.com
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Toranomon Hospital research committee (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/07/2015 | Yes | No |