Biliary ObstructionNCT03925766
Laparoscopy-Assisted Transgastric ERCP
An observational study of Biliary Obstruction, run by Tecnologico de Monterrey at 1 site in Mexico.
Trial summary
We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Biliary Obstruction
- How many people
- 1 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2019to 20 Apr 2019
- 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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patient with altered Roux en Y Gastric Bypass anatomy
Who may be able to join
- Patient with altered Roux en Y Gastric Bypass anatomy
Who cannot join
- Patients without Roux en Y Gastric Bypass anatomy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Escuela Nacional de Medicina, Tecnologico de Monterrey
Monterrey, Nuevo León, 76140
About this study
Official title: Laparoscopy-Assisted Transgastric Endoscopic Retrograde Cholangiopancreatography for Choledocholithiasis After Roux-en-Y Gastric Bypass
We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed. The presentation of the case is presented as well a review of the literature.
Read the detailed description
The exclusion of the stomach after Roux-en-Y-Gastric bypass (RYGB) makes access to the biliary tree very challenging for the surgeon or the endoscopist. There are different techniques described to overcome this downside, being laparoscopic assisted trans-gastric endoscopic retrograde cholangiopancreatography (ERCP) approach an outstanding method to access the remnant stomach for reaching the duodenal papilla, with a high rate of success reported. We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed, introducing the duodenoscope through a gastrostomy without the need of an intra-gastric trocar. The patient evolved favorably and was discharged on his second postoperative day without complications.
- Conditions
- Biliary Obstruction
- Keywords
- biliary disease, gallstones, obesity
- Medical subject headings
- Gallbladder Diseases, Gallstones, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Proof the efficacy of laparoscopic assisted transgastric endoscopic retrograde cholangiopancreatography
This technique is a feasible and achievable procedure with low rate of complications for treating patients with altered RYGB anatomy that present biliary tract disorders, allowing an endoscopic treatment and cholecystectomy to be performed in a single setting.
Measured: April 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Mar 2019
- Primary completion1 Apr 2019
- Study completion20 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary ObstructionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tecnologico de Monterrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925766
- Sponsor's protocol ID
- LAERCP002
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopy-Assisted Transgastric Endoscopic Retrograde Cholangiopancreatography for Choledocholithiasis After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT03925766
- Acronym / sponsor ID
- LAERCP002
- Conditions
- Biliary Obstruction
- Keywords
- biliary disease, gallstones, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Tecnologico de MonterreyUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 24 Apr 2019 (actual)
- 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.
We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed. The presentation of the case is presented as well a review of the literature.
Detailed description
The exclusion of the stomach after Roux-en-Y-Gastric bypass (RYGB) makes access to the biliary tree very challenging for the surgeon or the endoscopist. There are different techniques described to overcome this downside, being laparoscopic assisted trans-gastric endoscopic retrograde cholangiopancreatography (ERCP) approach an outstanding method to access the remnant stomach for reaching the duodenal papilla, with a high rate of success reported. We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed, introducing the duodenoscope through a gastrostomy without the need of an intra-gastric trocar. The patient evolved favorably and was discharged on his second postoperative day without complications.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with altered Roux en Y Gastric Bypass anatomy
Key inclusion criteria (1 listed)
- Patient with altered Roux en Y Gastric Bypass anatomy
Key exclusion criteria (1 listed)
- Patients without Roux en Y Gastric Bypass anatomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proof the efficacy of laparoscopic assisted transgastric endoscopic retrograde cholangiopancreatography
Time frame: April 2019
This technique is a feasible and achievable procedure with low rate of complications for treating patients with altered RYGB anatomy that present biliary tract disorders, allowing an endoscopic treatment and cholecystectomy to be performed in a single setting.
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 24 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obstruction, run by Tecnologico de Monterrey at 1 site in Mexico.
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 1 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 24 Apr 2019. 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 Mexico. 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?
Proof the efficacy of laparoscopic assisted transgastric endoscopic retrograde cholangiopancreatography (time frame: April 2019). 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 24 Apr 2019; AzTrials last refreshed its copy on 27 Oct 2026.