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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lemmers Arnaud, Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT01537848
First received: February 17, 2012
Last updated: February 23, 2012
Last verified: February 2012
History of Changes

February 17, 2012
February 23, 2012
January 2002
July 2011   (final data collection date for primary outcome measure)
Treatment success [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]
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
Treatment success [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]
regression of collection = resolution of collection as shown on abdominal imaging (Ct or MRI) in association of clinical resolution of symptoms at 8 weeks of follow-up
Complete list of historical versions of study NCT01537848 on ClinicalTrials.gov Archive Site
technical success [ Time Frame: day of procedure (day 1) ] [ Designated as safety issue: Yes ]
Success to access and drain the collection by the placement of transmural drain and/or stent(s)
technical success [ Time Frame: day of procedure (day 1) ] [ Designated as safety issue: Yes ]
success to access and drain the colletion by the placement of transmural drain and/or stent
Not Provided
Not Provided
 
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

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.
Post-surgical Intra-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)
post-operative collection
patients suffering from a post-operative abdominal collection
Intervention: Procedure: EUS guided transmural drainage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
February 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
15 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01537848
EUS in surgical collection, P2012/059
No
Lemmers Arnaud, Erasme University Hospital
Erasme University Hospital
Not Provided
Study Chair: Jacques Devière, MD,PhD Erasme Hospital, ULB (Université Libre de Bruxelles), Belgium
Erasme University Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP