Biliary DiseaseNCT01620632
Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome
An observational study of Biliary Disease and Pancreas Disease, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to collect data on the technical aspects of Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients with Roux-en-Y gastric bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Disease, Pancreas Disease
- What is being tested?
- Laparoscopy assisted ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to 2 Jul 2018
- Phase
- Observational
- 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
Study population: Those patients who have altered gastric anatomy that require a laparoscopy assisted ERCP
Who may be able to join
- Age 18 years and older
- Altered gastric anatomy
- Scheduled to undergo laparoscopy-assisted ERCP
Who cannot join
- Any contraindications to performing endoscopy
- Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
- The subject is unable/unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: Prospective Evaluation of the Clinical Utility of Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatomy
The purpose of this research study is to collect data on the technical aspects of Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients with Roux-en-Y gastric bypass surgery.
Read the detailed description
Patients would have had a Roux-en-Y gastric bypass in the past that had altered their gastric anatomy. Now they have developed bilary and/or pancreatic problems that require and ERCP. With their altered gastric anatomy a standard ERCP would not be possible. Thus they are scheduled for a Laparoscopy-assisted ERCP.
- Conditions
- Biliary Disease, Pancreas Disease
- Being tested
- Laparoscopy assisted ERCP
- Keywords
- laparoscopy assisted ERCP, altered gastric anatomy
- Medical subject headings
- Gallbladder Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopy assisted ERCPProcedure or surgery
Also called Endoscopic Retrograde Cholangiopancreatography (ERCP), Roux-en-Y gastric bypass surgery, Laparoscopy
Patients will go the the Operating room and through laparoscopy will have an ERCP for their medical indication.
| Study group | Role | What they receive |
|---|---|---|
| Altered gastric anatomy | Patients who have an altered gastric who need an ERCP Receives: Procedure: Laparoscopy assisted ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients with altered gastric anatomy who need an ERCP
Measured: approximately one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startDec 2011
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter V Draganov, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620632
- Sponsor's protocol ID
- IRB201600462
- Other IDs
- 511-2011
- Status last verified
- Jul 2018
- First submitted
- 13 Jun 2012
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Clinical Utility of Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatomy
- ClinicalTrials.gov ID
- NCT01620632
- Acronym / sponsor ID
- IRB201600462
- Conditions
- Biliary Disease, Pancreas Disease
- Keywords
- laparoscopy assisted ERCP, altered gastric anatomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 15 Jun 2012 (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 research study is to collect data on the technical aspects of Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients with Roux-en-Y gastric bypass surgery.
Detailed description
Patients would have had a Roux-en-Y gastric bypass in the past that had altered their gastric anatomy. Now they have developed bilary and/or pancreatic problems that require and ERCP. With their altered gastric anatomy a standard ERCP would not be possible. Thus they are scheduled for a Laparoscopy-assisted ERCP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Altered gastric anatomy | – | Procedure: Laparoscopy assisted ERCPPatients who have an altered gastric who need an ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those patients who have altered gastric anatomy that require a laparoscopy assisted ERCP
Key inclusion criteria (3 listed)
- Age 18 years and older
- Altered gastric anatomy
- Scheduled to undergo laparoscopy-assisted ERCP
Key exclusion criteria (3 listed)
- Any contraindications to performing endoscopy
- Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
- The subject is unable/unwilling 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 |
|---|---|---|
| Laparoscopy assisted ERCPAlso: Endoscopic Retrograde Cholangiopancreatography (ERCP), Roux-en-Y gastric bypass surgery, LaparoscopyPatients will go the the Operating room and through laparoscopy will have an ERCP for their medical indication. | Procedure or surgery | Altered gastric anatomy |
Primary outcome
patients with altered gastric anatomy who need an ERCP
Time frame: approximately one week
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 9 Jul 2018.
Related trials for Biliary Disease
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
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 V 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 Biliary Disease and Pancreas Disease, 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 3 inclusion and 3 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 9 Jul 2018. 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 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?
patients with altered gastric anatomy who need an ERCP (time frame: approximately one week). 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 9 Jul 2018.