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.

Study Overview

• Status: Completed
• Conditions: Post-surgical Intra-abdominal Collection
• Intervention / Treatment: Procedure: EUS guided transmural drainage

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme Hospital, Gastroenterology Department, ULB (Université libre de Bruxelles)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success	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	8 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
technical success	Success to access and drain the collection by the placement of transmural drain and/or stent(s)	day of procedure (day 1)

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Study Chair: Jacques Devière, MD,PhD, Erasme Hospital, ULB (Université Libre de Bruxelles), Belgium

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Estimate): February 24, 2012
• Last Update Submitted That Met QC Criteria: February 23, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: EUS; Endoscopic ultrasound; post-operative; abdominal collection; post-surgical
• Other Study ID Numbers: EUS in surgical collection; P2012/059 (Other Identifier: Erasme Hospital Ethics Committee)