Pancreatobiliary DiseaseNCT01238341
Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy
An observational study of Pancreatobiliary Disease and Altered Gastric Anatomy, run by University of Florida at 1 site in United States.
Trial summary
In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatobiliary Disease, Altered Gastric Anatomy
- What is being tested?
- Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients who have a medical indication for ERCP and have altered gastric anatomy and are referred for the procedure as part of their standard medical care will be considered for this study.
Who may be able to join
- Subject is 18 years or older
- Subject has medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Subject has altered gastric anatomy
- Subject must be able to give informed consent.
Who cannot join
- Any contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with overtube
- The subject is unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands at UF Endoscoppy Center
Gainesville, Florida, 32608
About this study
Official title: Prospective Evaluation of Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) With Overtube in Patients With Altered Gastric Anatomy
In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).
- Conditions
- Pancreatobiliary Disease, Altered Gastric Anatomy
- Being tested
- Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Keywords
- Pancreatobiliary disease in patients with altered gastric anatomy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Retrograde Cholangiopancreatography (ERCP)Procedure or surgery
An Endoscopic Retrograde Cholangiopancreatography (ERCP) performed with an overtube in the evaluation of pancreatobiliary disease in patients with altered gastric anatomy
| Study group | Role | What they receive |
|---|---|---|
| Pancreatobiliary disease | Patients who have altered gastric anatomy who need an ERCP with an overtube for evaluation of pancreatobiliary disease. Receives: Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Papilla or Duct-enterostomy Was Reached
Measured: During procedure, up to 3 hours
Secondary outcomes (3)
Successful Cannulation of the Duct of Intent
Deep cannulation of the bile/pancreatic duct was indicated in 12 of 13 ERCPs, one procedure was performed for stent removal only. This outcome was only relevant when deep cannulation was clinically indicated, therefore this outcome was determined out of 12 ERCPs.
Measured: During procedure, up to 3 hours
Successful Endoscopic Therapy
Measured: During procedure, up to 3 hours
Total Procedure Time
Measured: During procedure, up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startJun 2007
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatobiliary DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Draganov, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238341
- Sponsor's protocol ID
- Pancreatobiliary disorders
- Status last verified
- Oct 2015
- First submitted
- 8 Nov 2010
- Last updated
- 23 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wagh MS, Draganov PV. Prospective evaluation of spiral overtube-assisted ERCP in patients with surgically altered anatomy. Gastrointest Endosc. 2012 Aug;76(2):439-43. doi: 10.1016/j.gie.2012.04.444. No abstract available.
PubMed 22817798
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) With Overtube in Patients With Altered Gastric Anatomy
- ClinicalTrials.gov ID
- NCT01238341
- Acronym / sponsor ID
- Pancreatobiliary disorders
- Conditions
- Pancreatobiliary Disease, Altered Gastric Anatomy
- Keywords
- Pancreatobiliary disease in patients with altered gastric anatomy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Posted 5 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatobiliary disease | – | Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)Patients who have altered gastric anatomy who need an ERCP with an overtube for evaluation of pancreatobiliary disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a medical indication for ERCP and have altered gastric anatomy and are referred for the procedure as part of their standard medical care will be considered for this study.
Key inclusion criteria (4 listed)
- Subject is 18 years or older
- Subject has medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Subject has altered gastric anatomy
- Subject must be able to give informed consent.
Key exclusion criteria (2 listed)
- Any contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with overtube
- The subject is unable to give informed consent
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 |
|---|---|---|
| Endoscopic Retrograde Cholangiopancreatography (ERCP)An Endoscopic Retrograde Cholangiopancreatography (ERCP) performed with an overtube in the evaluation of pancreatobiliary disease in patients with altered gastric anatomy | Procedure or surgery | Pancreatobiliary disease |
Primary outcome
Papilla or Duct-enterostomy Was Reached
Time frame: During procedure, up to 3 hours
3 secondary outcomes
Successful Cannulation of the Duct of Intent
Time frame: During procedure, up to 3 hours
Successful Endoscopic Therapy
Time frame: During procedure, up to 3 hours
Total Procedure Time
Time frame: During procedure, up to 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22817798Wagh MS, Draganov PV. Prospective evaluation of spiral overtube-assisted ERCP in patients with surgically altered anatomy. Gastrointest Endosc. 2012 Aug;76(2):439-43. doi: 10.1016/j.gie.2012.04.444. No abstract available.
Related trials for Pancreatobiliary Disease
RecruitingPhase 2
A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatobiliary Cancers
Pancreatobiliary Cancers, Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
Iconographic Registry of Pancreatobiliary Endoscopy Procedures
Pancreas Neoplasm, Cancer of Pancreas
RecruitingObservational study
Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK)
Breast Cancer, Lung Cancer
Recruiting
Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers
Stage IV Esophageal Adenocarcinoma, Stage IV Esophageal Squamous Cell Carcinoma
Active, not recruitingObservational study
Integrated Molecular Profiling in Advanced Cancers Trial
Breast Cancer, Non-small Cell Lung Cancer
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.
Peter Draganov, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatobiliary Disease and Altered Gastric Anatomy, run by University of Florida 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 2 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 23 Oct 2015. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Papilla or Duct-enterostomy Was Reached (time frame: During procedure, up to 3 hours). 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 NCT01238341, which also lists 1 linked publication.
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 23 Oct 2015.