Pancreas CancerNCT00841607
Reconstruction Following Pancreaticoduodenectomy: A Randomized Clinical Trial of Pancreaticojejunostomy vs Pancreaticogastomy
A study testing pancreaticojejunostomy vs pancreaticogastrostomy in people with Pancreas Cancer and Periampullary Cancer, run by Tom Baker Cancer Centre at 1 site in Canada.
Trial summary
Pancreaticoduodenectomy (PD or Whipple procedure) involves the removal of the head of the pancreas and is the primary modality for treatment of peri-ampullary cancers (arising from the common bile duct, Ampulla of Vater, duodenum, neuroendocrine cells of the pancreas, and most commonly the exocrine pancreas). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Periampullary Cancer
- What is being tested?
- pancreaticojejunostomy vs pancreaticogastrostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2006to May 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected pancreatic or periampullary neoplasm that appears to be resectable based on preoperative imaging (CT scan and/or MRI) and are deemed medically fit to undergo PD.
Who cannot join
- Patients less than 18 years of age will be excluded.
- As well, patients with distant metastasis, local unresectability, and/or gastric involvement will be excluded.
- Other exclusion criteria include:
- female subjects who are pregnant or nursing
- current use of an investigational drug
- currently receiving chemotherapy or radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Pancreaticoduodenectomy (PD or Whipple procedure) involves the removal of the head of the pancreas and is the primary modality for treatment of peri-ampullary cancers (arising from the common bile duct, Ampulla of Vater, duodenum, neuroendocrine cells of the pancreas, and most commonly the exocrine pancreas). In Canada, cancer of the pancreas is the 11th cancer in terms of new cases/year, and the 5th leading cause of cancer related deaths/year. Following PD the remaining pancreas is re-connected to a portion of the gastrointestinal tract; the pancreas is very soft and difficult to sew and connect safely. The primary cause of complications following PD is related to leak occurring at this connection. Of patients that develop a leak, over half need a second operation, and up to 40% will die. The two main organs that the pancreas may be re-connected to are the jejunum or the stomach. The investigators will compare the rates of pancreatic leakage in two groups of patients randomized to reconnection to either the jejunum or stomach following PD. The goal of this study is to determine which of these methods is safer. The results may change practice patterns across North America and the world. It may in the future prevent many cases of avoidable leakage and the resulting morbidity of this including death. This will therefore reduce the morbidity and mortality of this group of cancer patients.
- Conditions
- Pancreas Cancer, Periampullary Cancer
- Being tested
- pancreaticojejunostomy vs pancreaticogastrostomy
- Keywords
- whipple, pancreas, reconstruction, leak, fistula
- Medical subject headings
- Pancreatic Neoplasms, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticojejunostomy vs pancreaticogastrostomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pancreaticojejunostomy | Experimental | Pancreaticojejunostomy reconstruction used following Whipple surgery. Receives: Procedure: pancreaticojejunostomy vs pancreaticogastrostomy |
| Pancreaticogastomy | Active comparator | Pancreaticogastomy reconstruction used following Whipple surgery. Receives: Procedure: pancreaticojejunostomy vs pancreaticogastrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic leak/fistula
Either a radiologically proved anastomotic leak or the continued drainage (via drain, enterocutaneous fistula, or wound) of amylase (or lipase) rich fluid on or after postoperative day 10. This is a clinically relevant definition which has been used in many other reports.
Measured: Up to POD 10
Secondary outcomes (1)
overall morbidity
We will use the definition and classification of complications resulting from surgery as put forth by Clavien et al which has been widely adopted in the surgical literature.
Measured: Up to POD 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startAug 2006
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreas 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
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tom Baker Cancer Centre
- Sponsor type
- University, hospital or other
- Collaborators
- M.S.I. Foundation, University of Calgary, Canadian Association of General Surgeons
- Responsible party
- Principal investigator, Elijah Dixon, Tom Baker Cancer Centre
- Investigators
- elijah dixon, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841607
- Sponsor's protocol ID
- 18982
- Status last verified
- Oct 2016
- First submitted
- 10 Feb 2009
- Last updated
- 18 Oct 2016
- Results posted
- No
Publications
McKay A, Mackenzie S, Sutherland FR, Bathe OF, Doig C, Dort J, Vollmer CM Jr, Dixon E. Meta-analysis of pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy. Br J Surg. 2006 Aug;93(8):929-36. doi: 10.1002/bjs.5407.
PubMed 16845693Grendar J, Ouellet JF, Sutherland FR, Bathe OF, Ball CG, Dixon E. In search of the best reconstructive technique after pancreaticoduodenectomy: pancreaticojejunostomy versus pancreaticogastrostomy. Can J Surg. 2015 Jun;58(3):154-9. doi: 10.1503/cjs.010014.
PubMed 25799130
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction Following Pancreaticoduodenectomy: A Randomized Clinical Trial of Pancreaticojejunostomy vs Pancreaticogastomy
- ClinicalTrials.gov ID
- NCT00841607
- Acronym / sponsor ID
- 18982
- Conditions
- Pancreas Cancer, Periampullary Cancer
- Keywords
- whipple, pancreas, reconstruction, leak, fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Tom Baker Cancer CentreUniversity, hospital or other
- Collaborators
- M.S.I. Foundation, University of Calgary, Canadian Association of General Surgeons
- Study start
- Aug 2006
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Feb 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.
Pancreaticoduodenectomy (PD or Whipple procedure) involves the removal of the head of the pancreas and is the primary modality for treatment of peri-ampullary cancers (arising from the common bile duct, Ampulla of Vater, duodenum, neuroendocrine cells of the pancreas, and most commonly the exocrine pancreas). In Canada, cancer of the pancreas is the 11th cancer in terms of new cases/year, and the 5th leading cause of cancer related deaths/year. Following PD the remaining pancreas is re-connected to a portion of the gastrointestinal tract; the pancreas is very soft and difficult to sew and connect safely. The primary cause of complications following PD is related to leak occurring at this connection. Of patients that develop a leak, over half need a second operation, and up to 40% will die. The two main organs that the pancreas may be re-connected to are the jejunum or the stomach. The investigators will compare the rates of pancreatic leakage in two groups of patients randomized to reconnection to either the jejunum or stomach following PD. The goal of this study is to determine which of these methods is safer. The results may change practice patterns across North America and the world. It may in the future prevent many cases of avoidable leakage and the resulting morbidity of this including death. This will therefore reduce the morbidity and mortality of this group of cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreaticojejunostomy | Experimental | Procedure: pancreaticojejunostomy vs pancreaticogastrostomyPancreaticojejunostomy reconstruction used following Whipple surgery. |
| Pancreaticogastomy | Active comparator | Procedure: pancreaticojejunostomy vs pancreaticogastrostomyPancreaticogastomy reconstruction used following Whipple surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suspected pancreatic or periampullary neoplasm that appears to be resectable based on preoperative imaging (CT scan and/or MRI) and are deemed medically fit to undergo PD.
Key exclusion criteria (6 listed)
- Patients less than 18 years of age will be excluded.
- As well, patients with distant metastasis, local unresectability, and/or gastric involvement will be excluded.
- female subjects who are pregnant or nursing
- current use of an investigational drug
- currently receiving chemotherapy or radiotherapy.
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 |
|---|---|---|
| pancreaticojejunostomy vs pancreaticogastrostomy | Procedure or surgery | Pancreaticogastomy, Pancreaticojejunostomy |
Primary outcome
pancreatic leak/fistula
Time frame: Up to POD 10
Either a radiologically proved anastomotic leak or the continued drainage (via drain, enterocutaneous fistula, or wound) of amylase (or lipase) rich fluid on or after postoperative day 10. This is a clinically relevant definition which has been used in many other reports.
1 secondary outcome
overall morbidity
Time frame: Up to POD 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Background: PubMed 16845693McKay A, Mackenzie S, Sutherland FR, Bathe OF, Doig C, Dort J, Vollmer CM Jr, Dixon E. Meta-analysis of pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy. Br J Surg. 2006 Aug;93(8):929-36. doi: 10.1002/bjs.5407.
- Derived from this study: PubMed 25799130Grendar J, Ouellet JF, Sutherland FR, Bathe OF, Ball CG, Dixon E. In search of the best reconstructive technique after pancreaticoduodenectomy: pancreaticojejunostomy versus pancreaticogastrostomy. Can J Surg. 2015 Jun;58(3):154-9. doi: 10.1503/cjs.010014.
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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.
elijah dixon, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreaticojejunostomy vs pancreaticogastrostomy in people with Pancreas Cancer and Periampullary Cancer, run by Tom Baker Cancer Centre at 1 site in Canada.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 18 Oct 2016. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 leak/fistula (time frame: Up to POD 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00841607, which also lists 2 linked publications.
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 18 Oct 2016.