Condition category
Digestive System
Date applied
13/12/2014
Date assigned
16/01/2015
Last edited
28/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kazunari Sasaki

ORCID ID

Contact details

2-2-2 Toranomon Minato-ku
Tokyo
105-8470
Japan

Additional identifiers

EudraCT 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

Human ethical committee of Toranomon hospital

Study design

Single center prospective

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

Mortality and morbidity.

We evaluated outcome from just after operation to most recent outpatient clinic visit.

Secondary outcome measures

N/A

Overall trial start date

01/01/2012

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Patients requiring laparoscopic pancreaticoduodenectomy who agree with using the new technique

Participant type

Other

Age group

All

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26133767

Publication citations

Additional files

Editorial Notes