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Trial record 3 of 298 for:    Recruiting, Not yet recruiting, Available Studies | "Adenoma"

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

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ClinicalTrials.gov Identifier: NCT02880748
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adenoma Other: Water exchange (WE) method Other: Air insufflation (AI) method. Not Applicable

Detailed 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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Water exchange (WE) method
Water exchange (WE) method was used for insertion to the cecum.
Other: Water exchange (WE) method
Water exchange (WE) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.

Active Comparator: Air insufflation (AI) method
Air insufflation (AI) method was used for insertion to the cecum.
Other: Air insufflation (AI) method.
Air insufflation (AI) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.




Primary Outcome Measures :
  1. Adenoma miss rate [ Time Frame: 12 months ]
    Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group.


Secondary Outcome Measures :
  1. adenoma-level miss rate [ Time Frame: 12 months ]
    Adenoma-level miss rate was calculated as the number of additional adenomas detected in polypectomy procedure divided by the total number of adenomas in each group.

  2. Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy [ Time Frame: 12 months ]
    Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.

  3. Adenoma per positive patient (APP) [ Time Frame: 12 months ]
    The mean number of adenoma per positive patient

  4. Quality of Bowel Preparation [ Time Frame: 12 months ]
    The Boston Bowel Preparation Scale (BBPS): cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.

  5. Complication rate [ Time Frame: 12 months ]
    Bleeding, perforation and others

  6. Pain Scores on the Visual Analog Scale compared with previous colonoscopy [ Time Frame: 12 months ]
    0 = no pain, to 10 = most severe pain



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880748


Contacts
Contact: Gui Ren, MD +86298477136 renguigz@hotmail.com

Locations
China, Shaanxi
Endoscopic center, Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Gui Ren, MD    +862984771536    renguigz@hotmail.com   
Principal Investigator: Gui Ren, MD         
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Yanglin Pan, MD Xijing Hospital of Digestive Diseases

Publications:
Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02880748     History of Changes
Other Study ID Numbers: KY20162059-2
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yanglin Pan, Fourth Military Medical University:
Water exchange colonoscopy
Adenoma miss rate
Polyps

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms