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

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Key information

Conditions

Post-surgical Intra-abdominal Collection

Age range

15 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme Hospital, Gastroenterology Department, ULB (Université libre de Bruxelles)

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS guided transmural drainage

Procedure

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)

Primary outcomes

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2011
Study completion: 2012
First posted: Feb 23, 2012
Registry last updated: Feb 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.