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

Post-surgical Intra-abdominal Collection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537848
• Other study ID #: EUS in surgical collection
• Secondary ID: P2012/059
• Status: Completed
• Phase: N/A
• First received: February 17, 2012
• Last updated: February 23, 2012
• Start date: January 2002
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Post-surgical Intra-abdominal Collection

Intervention

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.

Locations

Country	Name	City	State
Belgium	Erasme Hospital, Gastroenterology Department, ULB (Université libre de Bruxelles)	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	technical success	Success to access and drain the collection by the placement of transmural drain and/or stent(s)	day of procedure (day 1)	Yes