Clinical Trials Directory

Trials / Completed

CompletedNCT01537848

Retrospective Study of Endoscopic Ultrasound (EUS) Guided Transmural Drainage of Post-operative Abdominal Collections

Retrospective Study of Endoscopic Ultrasound Guided Transmural Drainage of Post-operative Collections

Status
Completed
Phase
Study type
Observational
Enrollment
43 (actual)
Sponsor
Erasme University Hospital · Academic / Other
Sex
All
Age
15 Years – 90 Years
Healthy volunteers
Not accepted

Summary

This is a retrospective study of a single center on endoscopic ultrasound (EUS) guided transmural drainage of post-operative collections during a 9 years period.

Detailed description

All patients who underwent a EUS guided drainage of post-operative collection between 2002 and 2011 in the endoscopy unit of Erasme hospital will be included for analysis. The study will focus on retrospective analysis of prospectively collected data. The technique is the same as the one used for pancreatic pseudocysts drainage. The technical success is defined as the ability to access and drain the collection by placement of transmural drain and/or stents. Treatment success (regression of collection) is defined as the resolution of the collection as shown on abdominal imaging (CT or MRI) in association with clinical resolution of symptoms at 8 weeks of follow-up.

Conditions

Interventions

TypeNameDescription
PROCEDUREEUS guided transmural drainagePuncture of the collection is done under EUS guidance using a linear echoendoscope (FG-3830UT, Pentax or Olympus GF-UCT140/180 or forward viewing scope (Olympus)) with a 19G echoTip needle or a cystotome (Cook Medical Inc.). Then a 0.035 guidewire is inserted in the collection and the hole is enlarged with a cystotome (Cook Medical) or a 6.5F diathermic sleeve (Endoflex) and sometimes if needed a 6-8mm CRE balloon (Boston Scientific) before stenting with one or two double pigtail plastic stents (Cook Endoscopy, Endoflex). A nasocystic drain was also put whenever needed. If only a single stent could be placed in the first attempt, a subsequent procedure is scheduled for insertion of additional stents after dilation of the tract. There isn't any specific drug given during the procedure.

Timeline

Start date
2002-01-01
Primary completion
2011-07-01
Completion
2012-02-01
First posted
2012-02-23
Last updated
2012-02-24

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT01537848. Inclusion in this directory is not an endorsement.