A novel laparscopic pancreaticogastrostomy technique
| ISRCTN | ISRCTN16761283 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16761283 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/12/2014
- Registration date
- 16/01/2015
- Last edited
- 28/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
2-2-2 Toranomon Minato-ku
Tokyo
105-8470
Japan
Study information
| Study design | Single center prospective |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Pancreaticogastrostomy in pure laparoscopic pancreaticoduodenectomy - a novel pancreatic-gastric anastomosis technique |
| Study objectives | To validate new technique safety |
| Ethics approval(s) | Human ethical committee of Toranomon hospital |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 5 |
| Key inclusion criteria | Patients requiring laparoscopic pancreaticoduodenectomy who agree with using the new technique |
| Key exclusion criteria | N/A |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Japan
Study participating centre
Tokyo
105-8470
Japan
Sponsor information
Hospital/treatment centre
2-2-2 Toranomon Minato-ku
Tokyo
105-8470
Japan
| Phone | +81-3-3588-1111 |
|---|---|
| sasakikazunari1978@hotmail.com | |
"ROR" |
https://ror.org/05rkz5e28 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/07/2015 | Yes | No |
