Postoperative Pancreatic FistulaNCT01481753
Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying
A study testing pancreaticoduodenectomy without Braun enteroenterostomy and Braun enteroenterostomy in people with Postoperative Pancreatic Fistula and Delayed Gastric Emptying, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying (DGE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pancreatic Fistula, Delayed Gastric Emptying
- What is being tested?
- pancreaticoduodenectomy without Braun enteroenterostomy and Braun enteroenterostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Sep 2016
- 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
- Patients undergoing pancreaticoduodenectomy surgery at Johns Hopkins Hospital
Who cannot join
- Pregnant women
- Patients under the age of 18
- adults lacking ability to consent,
- patients scheduled for laparoscopic whipple surgery
- non-english-speakers, and
- prisoners
Trial locations and contacts
1 site in 1 country.
About this study
The investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying (DGE).
- Being tested
- pancreaticoduodenectomy without Braun enteroenterostomy, Braun enteroenterostomy
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticoduodenectomy without Braun enteroenterostomyProcedure or surgery
Also called No Braun
no Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy
Braun enteroenterostomyProcedure or surgery
addition of Braun enteroenterostomy (side-to-side anastomosis between the afferent and efferent loops of the gastrojejunostomy) to standard PD reconstruction can decrease the rates of POPF and/or DGE, improving the perioperative outcome of patients undergoing PD.
| Study group | Role | What they receive |
|---|---|---|
| Braun arm | Active comparator | patients received Braun enteroenterostomy Receives: Procedure: Braun enteroenterostomy |
| Non Braun Arm | Active comparator | Patients do not receive a Braun enteroenterostomy Receives: Procedure: pancreaticoduodenectomy without Braun enteroenterostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy
patients will be assessed for post operative fistula and delayed gastric emptying during hospitalization and then interviewed at 90 days +/- 2 weeks from OR date to assess any unanticipated consequences after discharge. We are currently performing statistical analysis of outcome data on the first 100 consented whipple patients as outlined in Johns Hopkins Hospital (JHH)-approved Institutional Review Board (IRB) protocol.
Measured: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery
Secondary outcomes (1)
Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy
patients will be assessed for post operative fistula and delayed gastric emptying during hospitalization and then interviewed at 90 days +/- 2 weeks from OR date to assess any unanticipated consequences after discharge We are currently performing statistical analysis of outcome data on the first 100 consented whipple patients as outlined in JHH-approved IRB protocol
Measured: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startDec 2009
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: last patient recruited Feb 2015,completion of data review; study data do not meet statistical significance to answer proposed study question
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher L Wolfgang, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481753
- Sponsor's protocol ID
- NA_00021168
- Status last verified
- Mar 2017
- First submitted
- 10 Nov 2011
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying
- ClinicalTrials.gov ID
- NCT01481753
- Acronym / sponsor ID
- NA_00021168
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: last patient recruited Feb 2015,completion of data review; study data do not meet statistical significance to answer proposed study question
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Nov 2011 (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 investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying (DGE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Braun arm | Active comparator | Procedure: Braun enteroenterostomypatients received Braun enteroenterostomy |
| Non Braun Arm | Active comparator | Procedure: pancreaticoduodenectomy without Braun enteroenterostomyPatients do not receive a Braun enteroenterostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing pancreaticoduodenectomy surgery at Johns Hopkins Hospital
Key exclusion criteria (6 listed)
- Pregnant women
- Patients under the age of 18
- adults lacking ability to consent,
- patients scheduled for laparoscopic whipple surgery
- non-english-speakers, and
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 |
|---|---|---|
| pancreaticoduodenectomy without Braun enteroenterostomyAlso: No Braunno Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy | Procedure or surgery | Non Braun Arm |
| Braun enteroenterostomyaddition of Braun enteroenterostomy (side-to-side anastomosis between the afferent and efferent loops of the gastrojejunostomy) to standard PD reconstruction can decrease the rates of POPF and/or DGE, improving the perioperative outcome of patients undergoing PD. | Procedure or surgery | Braun arm |
Primary outcome
Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy
Time frame: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery
patients will be assessed for post operative fistula and delayed gastric emptying during hospitalization and then interviewed at 90 days +/- 2 weeks from OR date to assess any unanticipated consequences after discharge. We are currently performing statistical analysis of outcome data on the first 100 consented whipple patients as outlined in Johns Hopkins Hospital (JHH)-approved Institutional Review Board (IRB) protocol.
1 secondary outcome
Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy
Time frame: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery
Results and safety
The study was stopped early (reason given: last patient recruited Feb 2015,completion of data review; study data do not meet statistical significance to answer proposed study question). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
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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.
Christopher L Wolfgang, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreaticoduodenectomy without Braun enteroenterostomy and Braun enteroenterostomy in people with Postoperative Pancreatic Fistula and Delayed Gastric Emptying, run by Johns Hopkins University 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 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: stopped early, as of the sponsor's last update on 6 Mar 2017. 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 stopped early (reason given: last patient recruited Feb 2015,completion of data review; study data do not meet statistical significance to answer proposed study question). 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?
Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy (time frame: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery). 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 6 Mar 2017.