Colorectal Polyp
Conditions
Keywords
ESD, Traction assisted ESD, Polypectomy, Clip and thread ESD
Brief summary
The aim of this study is to evaluate the role of traction assisted ESD in comparison to traditional ESD on procedural time and outcome in patients with large, non pedunculated colorectal polyps.
Detailed description
Endoscopic polypectomy, has been proven to reduce Colorectal cancer incidence and mortality. Smaller lesions and pedunculated lesions can be removed by conventional polypectomy, Endoscopic mucosa resection (EMR). However, large sessile and flat lesions are difficult to remove En bloc with EMR, resulting in a high level of tumor recurrence. Endoscopic submucosal dissection (ESD) was developed during the 1990s in Japan to achieve En bloc resection of large neoplasms in the stomach but has in recent years also been extended into management of large (\>2 cm) and technically challenging colorectal polyps. Large series on the efficacy of ESD in removing benign lesions show high En bloc resection rates resulting in low numbers of recurrences. Traction assisted ESD was developed in Japan to further improve the technique and reduce procedural time, the literature on the efficacy of traction assisted ESD is however scarce and limited to Japanese studies. The aim in this study is to investigate the impact of this novel technique in comparison to traditional ESD on procedural time, En bloc resection rate, R0 resection rate and complication incidence.
Interventions
PROCEDURETraction assisted ESD
A clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD
PROCEDURETraditional ESD
Endoscopic submucosa dissection
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Randomisation to either traction assisted ESD or traditional ESD
Intervention model description
Prospective randomiced Clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* \> 2cm, flat or sessile colorectal polyp
Exclusion criteria
* Recurrencies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural time | 280 min, procedural time | Time consumption to complete the resection is measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| En bloc resection | 280 min, procedural time | En bloc resection rates will be recorded |
| R0 resection | 4-8 weeks, when pathological examination is completed | R0 resection rate, stated in the pathology report will be recorded |
| Complication incidence | 2 weeks, when the timeframe for delayed complications is over. | All complications both immediate and delayed will be recorded |
Countries
Sweden
Outcome results
None listed