Pancreatic SurgeryLEAPSNCT00671463
Pancreatic Stent to Prevent Leak After Distal Pancreatectomy
A study testing Pancreatic duct stenting in people with Pancreatic Surgery and Pancreatic Duct Stenting, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Surgery, Pancreatic Duct Stenting, Pancreatic Cancer
- What is being tested?
- Pancreatic duct stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2010
- 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
- Adult patients (greater than or equal to 18 years of age)
- Scheduled to undergo an elective laparoscopic or open distal pancreatectomy
- Willing to undergo pre-operative endoscopy
- Consenting to the procedure
Who cannot join
- Contraindication to abdominal surgery
- Contraindication to general anesthesia or distal pancreatectomy
- Contraindication to upper endoscopy or ERCP
- Prior history of gastric bypass or other abdominal surgery in whom the ampulla will not be accessible via routine ERCP
- Ongoing pancreatitis
- Pancreatic necrosis or abscess
- History of sphincter of Oddi dysfunction
- History of ERCP-induced pancreatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial
The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are common after pancreas surgery and can result in serious problems and post-operative pain. The study will compare two groups. One group will have the stent before surgery, and the other group will have standard pancreas surgery, no endoscopy, and no stent.
- Conditions
- Pancreatic Surgery, Pancreatic Duct Stenting, Pancreatic Cancer, Distal Pancreatectomy, Pancreatic Diseases, Pancreatic Cyst
- Being tested
- Pancreatic duct stenting
- Keywords
- Pancreas surgery, Pancreatic adenocarcinoma, Pancreatic neuroendocrine tumor, Pancreatic duct stenting
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases, Pancreatic Cyst, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic duct stentingProcedure or surgery
In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pre-operative pancreatic duct stenting Receives: Procedure: Pancreatic duct stenting |
| 2 | No intervention | Control group, no endoscopy and no stent pre-operatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic leak
Measured: Post-operative day 3
Secondary outcomes (3)
Peritoneal fluid analysis
Measured: Daily
Serum biochemical analysis
Measured: Daily
Clinical outcomes
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2010 (estimated)
Why it stopped: Anticipated high risk of pancreatitis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic SurgeryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Responsible party
- Principal investigator, William R. Brugge, MD, Massachusetts General Hospital
- Investigators
- Field F Willingham, MD, MPH, Study director, MGHDenise W Gee, MD, Study director, MGHSevdenur Cizginer, MD, Study director, MGHDavid W Rattner, MD, Principal investigator, MGHWilliam R Brugge, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671463
- Sponsor's protocol ID
- 2007P000965
- Acronym
- LEAPS
- Status last verified
- Jun 2013
- First submitted
- 1 May 2008
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00671463
- Acronym / sponsor ID
- LEAPS / 2007P000965
- Conditions
- Pancreatic Surgery, Pancreatic Duct Stenting, Pancreatic Cancer, Distal Pancreatectomy, Pancreatic Diseases, Pancreatic Cyst
- Keywords
- Pancreas surgery, Pancreatic adenocarcinoma, Pancreatic neuroendocrine tumor, Pancreatic duct stenting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Anticipated high risk of pancreatitis
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (estimated)
- First posted
- 5 May 2008 (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.
The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are common after pancreas surgery and can result in serious problems and post-operative pain. The study will compare two groups. One group will have the stent before surgery, and the other group will have standard pancreas surgery, no endoscopy, and no stent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Pancreatic duct stentingPre-operative pancreatic duct stenting |
| 2 | No intervention | –Control group, no endoscopy and no stent pre-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (greater than or equal to 18 years of age)
- Scheduled to undergo an elective laparoscopic or open distal pancreatectomy
- Willing to undergo pre-operative endoscopy
- Consenting to the procedure
Key exclusion criteria (8 listed)
- Contraindication to abdominal surgery
- Contraindication to general anesthesia or distal pancreatectomy
- Contraindication to upper endoscopy or ERCP
- Prior history of gastric bypass or other abdominal surgery in whom the ampulla will not be accessible via routine ERCP
- Ongoing pancreatitis
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 |
|---|---|---|
| Pancreatic duct stentingIn the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy. | Procedure or surgery | 1 |
Primary outcome
Pancreatic leak
Time frame: Post-operative day 3
3 secondary outcomes
Peritoneal fluid analysis
Time frame: Daily
Serum biochemical analysis
Time frame: Daily
Clinical outcomes
Time frame: Daily
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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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.
Field F Willingham, MD, MPH study director
MGH
Denise W Gee, MD study director
MGH
Sevdenur Cizginer, MD study director
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic duct stenting in people with Pancreatic Surgery and Pancreatic Duct Stenting, run by Massachusetts General Hospital at 1 site in United States.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 11 Jun 2013. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: Post-operative day 3). 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 11 Jun 2013.