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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01537848
First Posted: February 23, 2012
Last Update Posted: February 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lemmers Arnaud, Erasme University Hospital
  Purpose
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.

Condition Intervention
Post-surgical Intra-abdominal Collection Procedure: EUS guided transmural drainage

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study of Endoscopic Ultrasound Guided Transmural Drainage of Post-operative Collections

Resource links provided by NLM:


Further study details as provided by Lemmers Arnaud, Erasme University Hospital:

Primary Outcome Measures:
  • Treatment success [ Time Frame: 8 weeks after treatment ]
    Regression of collection = resolution of collection as shown on abdominal imaging (Ct or MRI) in association with clinical resolution of symptoms at 8 weeks of follow-up


Secondary Outcome Measures:
  • technical success [ Time Frame: day of procedure (day 1) ]
    Success to access and drain the collection by the placement of transmural drain and/or stent(s)


Enrollment: 43
Study Start Date: January 2002
Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
post-operative collection
patients suffering from a post-operative abdominal collection
Procedure: EUS guided transmural drainage
Puncture 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.
Other Names:
  • Echoendoscope (Pentax FG-3830UT; Olympus GF-UCT140/180)
  • 19G echoTip needle (Cook Medical)
  • Cystotome (Cook Medical)
  • diathermic sleeve (Endoflex)
  • CRE balloon (Boston Scientific)
  • double pigtail stents (Cook Endoscopy, Endoflex)

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.
  Eligibility

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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who underwent EUS guided drainage of post-operative collections admitted between january 2002 and july 2011 for this treatment in the endoscopic department of a single academic center will be included for analysis.
Criteria

Inclusion Criteria:

  • All patients who underwent EUS guided drainage of post-operative collections admitted between january 2002 and july 2011 for this treatment in the endoscopic department of a single academic center will be included for analysis.

Exclusion Criteria:

  • none (patients for whom other modalities of fluid drainage failed were also included in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537848


Locations
Belgium
Erasme Hospital, Gastroenterology Department, ULB (Université libre de Bruxelles)
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
Study Chair: Jacques Devière, MD,PhD Erasme Hospital, ULB (Université Libre de Bruxelles), Belgium
  More Information

Responsible Party: Lemmers Arnaud, MD, PhD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT01537848     History of Changes
Other Study ID Numbers: EUS in surgical collection
P2012/059 ( Other Identifier: Erasme Hospital Ethics Committee )
First Submitted: February 17, 2012
First Posted: February 23, 2012
Last Update Posted: February 24, 2012
Last Verified: February 2012

Keywords provided by Lemmers Arnaud, Erasme University Hospital:
EUS
Endoscopic ultrasound
abdominal collection
post-operative
post-surgical