Altered Gastric Anatomy, Pancreatobiliary Disease
Conditions
Keywords
Pancreatobiliary disease in patients with altered gastric anatomy.
Brief summary
In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).
Interventions
PROCEDUREEndoscopic Retrograde Cholangiopancreatography (ERCP)
An Endoscopic Retrograde Cholangiopancreatography (ERCP) performed with an overtube in the evaluation of pancreatobiliary disease in patients with altered gastric anatomy
Sponsors
University of Florida
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 years or older 2. Subject has medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP) 3. Subject has altered gastric anatomy 4. Subject must be able to give informed consent.
Exclusion criteria
1. Any contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with overtube 2. The subject is unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Papilla or Duct-enterostomy Was Reached | During procedure, up to 3 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Cannulation of the Duct of Intent | During procedure, up to 3 hours | 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. |
| Successful Endoscopic Therapy | During procedure, up to 3 hours | — |
| Total Procedure Time | During procedure, up to 3 hours | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Altered Gastric Anatomy Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Altered Gastric Anatomy |
|---|---|
| Age, Continuous | 59.3 years |
| Indications for Endoscopic Retrograde Cholangiopancreatography (ERCP) Bile duct stones | 1 participants |
| Indications for Endoscopic Retrograde Cholangiopancreatography (ERCP) Biliary obstruction | 5 participants |
| Indications for Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatic leak | 1 participants |
| Postsurgical anatomy Billroth II gastrectomy w/ Braun enteroenterostomy | 1 participants |
| Postsurgical anatomy Roux-en-Y gastric bypass | 3 participants |
| Postsurgical anatomy Roux-en-Y gastric bypass with hepaticojejunostomy | 1 participants |
| Postsurgical anatomy Roux-en-Y hepaticojejunostomy | 2 participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Papilla or Duct-enterostomy Was Reached
Time frame: During procedure, up to 3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altered Gastric Anatomy | Papilla or Duct-enterostomy Was Reached | 10 ERCPs |
Secondary
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.
Time frame: During procedure, up to 3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altered Gastric Anatomy | Successful Cannulation of the Duct of Intent | 8 ERCPs |
Secondary
Successful Endoscopic Therapy
Time frame: During procedure, up to 3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Altered Gastric Anatomy | Successful Endoscopic Therapy | 9 ERCPs |
Secondary
Total Procedure Time
Time frame: During procedure, up to 3 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Altered Gastric Anatomy | Total Procedure Time | 95.6 minutes |