To investigate whether prophylactic clipping (PC) after endoscopic mucosal resection (EMR) of a flat polyp in the colon prevents delayed bleeding (DB) and is cost-effective.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint measure is: (incidence of) significant DB <30days.
DB is defined as any bleeding occurring after the completion of the procedure
necessitating blood transfusion, hospitalization, or re-intervention (either
repeat endoscopy, angiography, or surgery) [15,20]. Self-limiting bleeding
managed on an outpatient basis or only emergency room presentation without
further hospitalization / blood transfusion is not included.
Secondary outcome
Secundary study parameters are amongst others: costeffectivity, quality of
life, (severe) complications related to PC, non-radical polypresection.
possibly confounding risk factors for the development of DB (eg. age, BMI,
smoking behaviour etc.).
Background summary
Approximately 17,500 endomucosal resections (EMR) of flat polyps are yearly
performed in the colon, mostly due to the spin-off of the national colorectal
cancer-screening program (NCCS). The most prevalent complication is delayed
bleeding (DB) with an incidence of 3%-10%. DB leads to hospitalization and
additional colonoscopies with substantial economic impact. A strategy to
prevent DB was investigated in several studies comparing prophylactic clipping
(PC) with a conservative (non-PC) management. Indeed, a positive effect on the
incidence of DB was reported in the PC group in these studies. Limitations of
these studies include the retrospective design, inclusion of all types of
polyps and sizes, lack of power and all reported studies were only performed in
tertiary referral hospitals. The current study proposal aims to investigate the
role of PC in preventing DB and the cost-effectiveness of this intervention in
clinical practice.
Study objective
To investigate whether prophylactic clipping (PC) after endoscopic mucosal
resection (EMR) of a flat polyp in the colon prevents delayed bleeding (DB) and
is cost-effective.
Study design
We will perform a multi-center, randomized, patient- blinded multicenter trial,
comparing two treatment strategies in 314 patients undergoing EMR for a colonic
lesion >2
cm.
Intervention
PC will be compared to standard care (no PC). Clips will be placed to
approximate the resection plane with a density of at least 1 clip per cm.
Study burden and risks
The patients are burdened with questionnaires (20min) at baseline and 30 days,
3 months and 180 days after the procedure .
178 patient will undergo PC. No complications of PC are known.
Geert Grooteplein Zuid 8
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 8
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- laterally spreading or sessile polyp morphology proximal to the splenic
flexure, measuring 2-6cm
- Method of polyp removal is EMR
- patients >18 years old
- Written informed consent
Exclusion criteria
- Pregnancy
- Active inflammatory colonic conditions (e.g. inflammatory bowel disease)
- American Society of Anesthesiology (ASA) Grade IV-V
- Previous resection or attempted resection of a lesion less than 30 days ago
- Residual adenoma left after previous intervention
- >1 lesion removed in the same session
- Involvement of valvula Bauhini or orificium appendix
- Endoscopic appearance of invasive malignancy (non-lifting Kato D, Kudo V pit
pattern)
- Macroscopic non-radical resection
- Clip deployed prior to the completion of the EMR for a perforation or a major
intra-procedural bleeding not treatable by coagulation
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 |
|---|---|
| ClinicalTrials.gov | NCT03309683 |
| CCMO | NL62949.091.17 |