NCT01712048

Brief Summary

The aim of this study is to compare the efficacy and safety of two standard methods of polypectomy (polyp removal), submucosal injection-assisted endoscopic mucosal resection (EMR) and full water emersion (without submucosal injection) EMR, for large colorectal polyps.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

7.3 years

First QC Date

October 19, 2012

Last Update Submit

February 6, 2020

Conditions

Colonic PolypsRectal Polyps

Outcome Measures

Primary Outcomes (1)

  • Adenoma recurrence rate

    6 months

Secondary Outcomes (2)

  • Adverse event rate

    48 hours

  • Procedure time

    24 hours

Study Arms (2)

Submucosal Injection EMR

ACTIVE COMPARATOR

For patients who are randomized to the "submucosal injection" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection.

Procedure: Submucosal Injection EMR

Underwater EMR

ACTIVE COMPARATOR

For patients who are randomized to the "underwater" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.

Procedure: Underwater EMR

Interventions

Submucosal Injection EMRPROCEDURE

Selective saline injection is applied to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection. EMR is then performed with a standard snare.

Submucosal Injection EMR
Underwater EMRPROCEDURE

Polypectomy is performed under full water emersion without the use of submucosal injection.

Underwater EMR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age \>18 years that are scheduled for endoscopic resection of large colo-rectal lesions who consent to this study.

You may not qualify if:

  • Patients unable to provide informed consent.
  • Patients with lesions showing adenoma invasion into the muscularis propria on EUS.
  • Patients without at least one colo-rectal lesions ≥ 20mm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Related Publications (5)

  • ROSENBERG N. Submucosal saline wheal as safety factor in fulguration or rectal and sigmoidal polypi. AMA Arch Surg. 1955 Jan;70(1):120-2. doi: 10.1001/archsurg.1955.01270070122021. No abstract available.

    PMID: 13217613BACKGROUND

  • Norton ID, Wang L, Levine SA, Burgart LJ, Hofmeister EK, Rumalla A, Gostout CJ, Petersen BT. Efficacy of colonic submucosal saline solution injection for the reduction of iatrogenic thermal injury. Gastrointest Endosc. 2002 Jul;56(1):95-9. doi: 10.1067/mge.2002.125362.

    PMID: 12085042BACKGROUND

  • Nelson DB. Techniques for difficult polypectomy. MedGenMed. 2004 Oct 25;6(4):12. No abstract available.

    PMID: 15775839BACKGROUND

  • Zarchy T. Risk of submucosal saline injection for colonic polypectomy. Gastrointest Endosc. 1997 Jul;46(1):89-90. doi: 10.1016/s0016-5107(97)70222-0. No abstract available.

    PMID: 9260717BACKGROUND

  • Kudo S, Kashida H, Nakajima T, Tamura S, Nakajo K. Endoscopic diagnosis and treatment of early colorectal cancer. World J Surg. 1997 Sep;21(7):694-701. doi: 10.1007/s002689900293.

    PMID: 9276699BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Kenneth Binmoeller, M.D.

    California Pacific Medical Center

    PRINCIPAL INVESTIGATOR

  • Christopher Hamerski, M.D.

    California Pacific Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Endoscopy Program Director

Study Record Dates

First Submitted

October 19, 2012

First Posted

October 23, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 10, 2020

Record last verified: 2020-02

Locations

US(1)