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Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy

A

Air Force Military Medical University of People's Liberation Army

Status

Unknown

Conditions

Adenoma

Treatments

Other: Water exchange (WE) method
Other: Air insufflation (AI) method.

Study type

Interventional

Funder types

Other

Identifiers

NCT02880748
KY20162059-2

Details and patient eligibility

About

Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy. And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy. The investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.

Full description

For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation.

For the AI method, water was not used, and air was insufflated during insertion.

Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size <3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).

Enrollment

450 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18-80 patients undergoing selective polypectomy

Exclusion criteria

  • Polyps found more than 6 months
  • Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer
  • Patients with history of inflammatory bowel disease
  • Patients with planning to undergo Endoscopic Submucosal Dissection(ESD)
  • Patients not undergoing standard bowel preparation
  • Patients with solid feces in the last stool after bowel preparation
  • Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy
  • Hemodynamically unstable
  • Pregnant women
  • Unable to provide informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

450 participants in 2 patient groups

Water exchange (WE) method
Experimental group
Description:
Water exchange (WE) method was used for insertion to the cecum.
Treatment:
Other: Water exchange (WE) method
Air insufflation (AI) method
Active Comparator group
Description:
Air insufflation (AI) method was used for insertion to the cecum.
Treatment:
Other: Air insufflation (AI) method.

Trial contacts and locations

1

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Central trial contact

Gui Ren, MD

Data sourced from clinicaltrials.gov

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