Trial Outcomes & Findings for Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy (NCT NCT01238341)

NCT ID: NCT01238341

Last Updated: 2015-10-23

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 7 participants
• Primary outcome timeframe: During procedure, up to 3 hours
• Results posted on: 2015-10-23

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

Baseline characteristics by cohort

Measure	Altered Gastric Anatomy n=7 Participants 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.
Age, Continuous	59.3 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
Postsurgical anatomy Roux-en-Y hepaticojejunostomy	2 participants n=5 Participants
Postsurgical anatomy Roux-en-Y gastric bypass	3 participants n=5 Participants
Postsurgical anatomy Roux-en-Y gastric bypass with hepaticojejunostomy	1 participants n=5 Participants
Postsurgical anatomy Billroth II gastrectomy w/ Braun enteroenterostomy	1 participants n=5 Participants
Indications for Endoscopic Retrograde Cholangiopancreatography (ERCP) Biliary obstruction	5 participants n=5 Participants
Indications for Endoscopic Retrograde Cholangiopancreatography (ERCP) Bile duct stones	1 participants n=5 Participants
Indications for Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatic leak	1 participants n=5 Participants

PRIMARY outcome

Timeframe: During procedure, up to 3 hours

Outcome measures

Measure	Altered Gastric Anatomy n=13 ERCP attempts 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.
Papilla or Duct-enterostomy Was Reached	10 ERCPs

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Altered Gastric Anatomy n=12 ERCPs 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.
Successful Cannulation of the Duct of Intent	8 ERCPs

SECONDARY outcome

Timeframe: During procedure, up to 3 hours

Outcome measures

Measure	Altered Gastric Anatomy n=13 ERCPs 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.
Successful Endoscopic Therapy	9 ERCPs

SECONDARY outcome

Timeframe: During procedure, up to 3 hours

Outcome measures

Measure	Altered Gastric Anatomy n=13 ERCPs 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.
Total Procedure Time	95.6 minutes Interval 24.0 to 149.0

Adverse Events

Altered Gastric Anatomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter V. Draganov

University of Florida

Phone: (352) 273-9472

Email: Peter.Draganov@medicine.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place