To evaluate the efficacy of Enterocutaneous fistula ( ECF) repair using the Biodesign enterocutaneous fistula plug ( Cook Medical).The primary objective of this study is to determine the feasibility, tolerance and primary technical success rate of…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Technical feasibility of the treatment protocol, including: to determine the
feasibility, tolerance and primary technical success rate of the
Enterocutaneous fistula repair using the Biodesign enterocutaneous fistula plug
( Cook Medical)
Secondary outcome
The secondary objective will be to evaluate the longterm success ( after 3, 6
and 12 months): permanent closure ( non-production, skin healing) of the
fistula.
Background summary
Enterocutaneous fistula ( ECF) is an uncommon postoperative complication that
places a significant burden on both the patient and the health care system. The
management of this complication is complex and involves early recognition and
control of sepsis, maintenance of adequate nutritional status, and protection
of the skin. Multiple etiologies are associated with ECF formation. Most
postoperative ECF*s develop secondary to inflammatory bowel disease or
malignancy . It may take months before an ECF heals , and some of them will
never close spontaneously.
Study objective
To evaluate the efficacy of Enterocutaneous fistula ( ECF) repair using the
Biodesign enterocutaneous fistula plug ( Cook Medical).
The primary objective of this study is to determine the feasibility, tolerance
and primary technical success rate of Enterocutaneous fistula repair using the
ECF-plug.
The secondary objective will be to evaluate the longterm success: permanent
closure ( non-production) of the fistula
Study design
A prospective, non-controlled single-institution pilot study.
Intervention
Percutaneous placement of Biodesign plug ( Cook Medical) in enterocutaneous
fistula according to protocol
Study burden and risks
Risk of CT: hypersensitivity to iodinated contrast medium, contrastnefropathy
in patient with increased risk. These risk are equal to the risk of any other
patient undergoing CT-scans
Risk of hypersensitivity to porcine material ( therefore the procedure is
contra-indicated in patients with a known hypersensitivity to porcine material.
plesmanlaan 121
amsterdam 1066 cx
NL
plesmanlaan 121
amsterdam 1066 cx
NL
Listed location countries
Age
Inclusion criteria
A longstanding ( more than 6 months ) therapy-resistant ( therapy according to AVL standard) low-output ( less than 200 ml/ 24 hours) ECF.
Size of the ECF : 2/6-mm diameter, length less than 18 cm.
Exclusion criteria
Sensitivity to porcine materials.
An abscess cavity that is not sufficiently drained
An abscess cavity that is immediately adjacent to the internal fistula opening
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43289.031.13 |