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

NCT02880748 | Unknown DMC

• 1 other identifier: KY20162059-2
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoma

Keywords

Water exchange colonoscopy; Adenoma miss rate; Polyps

Outcome Measures

Primary Outcomes (1)

• Adenoma miss rate

  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.

  12 months

Secondary Outcomes (6)

• adenoma-level miss rate

  12 months

• Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy

  12 months

• Adenoma per positive patient (APP)

  12 months

• Quality of Bowel Preparation

  12 months

• Complication rate

  12 months

Study Arms (2)

Water exchange (WE) method

EXPERIMENTAL

Water exchange (WE) method was used for insertion to the cecum.

Other: Water exchange (WE) method

Air insufflation (AI) method

ACTIVE COMPARATOR

Air insufflation (AI) method was used for insertion to the cecum.

Other: Air insufflation (AI) method.

Interventions

Water exchange (WE) method OTHER

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.

Water exchange (WE) method

Air insufflation (AI) method. OTHER

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.

Air insufflation (AI) method

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 patients undergoing selective polypectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (3)

• Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Gut. 2016 Mar;65(3):374-89. doi: 10.1136/gutjnl-2015-311110.

  PMID: 26873868 BACKGROUND

• Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25.

  PMID: 20579648 BACKGROUND

• Ren G, Wang X, Luo H, Yao S, Liang S, Zhang L, Dong T, Chen L, Tao Q, Guo X, Han Y, Pan Y. Effect of water exchange method on adenoma miss rate of patients undergoing selective polypectomy: A randomized controlled trial. Dig Liver Dis. 2021 May;53(5):625-630. doi: 10.1016/j.dld.2020.11.012. Epub 2020 Dec 31.

  PMID: 33390353 DERIVED

MeSH Terms

Conditions

Adenoma; Polyps

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Yanglin Pan, MD

  Xijing Hospital of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gui Ren, MD

CONTACT

+86298477136; renguigz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 26, 2016

Record last verified: 2016-08

Locations

CN (1)