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

NCT ID: NCT02880748

Last Updated: 2016-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-08-31

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.

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).

Conditions

Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Water exchange (WE) method

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

Group Type: EXPERIMENTAL

Water exchange (WE) method

Intervention Type: 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.

Air insufflation (AI) method

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

Group Type: ACTIVE_COMPARATOR

Air insufflation (AI) method.

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yanglin Pan

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanglin Pan, MD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive Diseases

Locations

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gui Ren, MD

Role: CONTACT

renguigz@hotmail.com

+86298477136

Facility Contacts

Gui Ren, MD

Role: primary

renguigz@hotmail.com

+862984771536

References

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.

Reference Type: BACKGROUND

PMID: 26873868 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20579648 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33390353 (View on PubMed)

Other Identifiers

KY20162059-2

Identifier Type: -

Identifier Source: org_study_id