Pancreatic CancerPG/PJNCT00855985
Anastomotic Techniques in Pancreaticoduodenectomy
A study testing type of anastomosis after pancreaticoduodenectomy in people with Pancreatic Cancer and Pancreatic Fistula, run by Lakeshore Hospital at 1 site in India.
Trial summary
There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Fistula
- What is being tested?
- type of anastomosis after pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2004to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head
- resectable tumour
Who cannot join
- chronic pancreatitis/benign tumours-
- tumours extending into the body of the pancreas
- tumours with metastasis beyond regional lymph nodes
- requirement for sub total pancreatectomy
- prolonged hypotension - < 80 mm of hg for more than 30 min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer
There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected.
Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior
- Conditions
- Pancreatic Cancer, Pancreatic Fistula
- Being tested
- type of anastomosis after pancreaticoduodenectomy
- Keywords
- Pancreatic anastomosis, Whipple operation
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
type of anastomosis after pancreaticoduodenectomyProcedure or surgery
pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy Receives: Procedure: type of anastomosis after pancreaticoduodenectomy |
| 2 | Active comparator | Pancreaticogastrostomy for reconstruction after pancreaticoduodenectomy Receives: Procedure: type of anastomosis after pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic fistula rate
Measured: 30 days
Secondary outcomes (4)
mortality
Measured: 90 days
Hospital stay
Measured: 90 days
need for postoperative intervention
Measured: 90 days
major complication
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startJul 2004
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakeshore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr H Ramesh, Lakeshore Hospital
- Investigators
- Hariharan Ramesh, MS MCh, Principal investigator, Lakeshore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855985
- Sponsor's protocol ID
- 001
- Acronym
- PG/PJ
- Status last verified
- Sep 2011
- First submitted
- 4 Mar 2009
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer
- ClinicalTrials.gov ID
- NCT00855985
- Acronym / sponsor ID
- PG/PJ / 001
- Conditions
- Pancreatic Cancer, Pancreatic Fistula
- Keywords
- Pancreatic anastomosis, Whipple operation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Lakeshore HospitalUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 5 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected.
Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: type of anastomosis after pancreaticoduodenectomyPancreaticojejunostomy for reconstruction after pancreaticoduodenectomy |
| 2 | Active comparator | Procedure: type of anastomosis after pancreaticoduodenectomyPancreaticogastrostomy for reconstruction after pancreaticoduodenectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head
- resectable tumour
Key exclusion criteria (5 listed)
- chronic pancreatitis/benign tumours-
- tumours extending into the body of the pancreas
- tumours with metastasis beyond regional lymph nodes
- requirement for sub total pancreatectomy
- prolonged hypotension - < 80 mm of hg for more than 30 min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| type of anastomosis after pancreaticoduodenectomypancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy | Procedure or surgery | 1, 2 |
Primary outcome
pancreatic fistula rate
Time frame: 30 days
4 secondary outcomes
mortality
Time frame: 90 days
Hospital stay
Time frame: 90 days
need for postoperative intervention
Time frame: 90 days
major complication
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hariharan Ramesh, MS MCh principal investigator
Lakeshore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing type of anastomosis after pancreaticoduodenectomy in people with Pancreatic Cancer and Pancreatic Fistula, run by Lakeshore Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pancreatic fistula rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2011.