Large Polyps in the Gastrointestinal Tract
Conditions
Keywords
submucosal cushion, polypectomy, endoscopic mucosal resection
Brief summary
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a safety cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation.
Detailed description
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a safety cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators decided to use blood drawn from the patient for injection under the lesion. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation. Blood can also have local hemostatic action preventing from bleeding during polypectomy.
Interventions
Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion
DRUGNormal saline
Normal saline will be injected under the lesion to create submucosal cushion
DRUGHPMC
Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Polyps equal or larger than 1 cm
Exclusion criteria
* Coagulopathy * Inability to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of the Submucosal Cushion | Immediately after the procedure, Up to 5 minutes |
Countries
United States
Participant flow
Recruitment details
No data on how participants were randomized, and no further baseline data (other than categorical age and sex) are available for this record. The PI has left the institution and has been contacted. Per the PI the data are no longer available and the study has not been published.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion
OR
Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
OR
Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized >= 18, <= 90 | 18 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Duration of the Submucosal Cushion
Time frame: Immediately after the procedure, Up to 5 minutes
Population: No data is available for this record. The PI has left the institution and has been contacted. Per the PI the data is no longer available and the study has not been published.