NCT07456007

Brief Summary

Although colonoscopy is currently regarded as the gold standard to detect and prevent colorectal cancer (CRC) but post-colonoscopy CRCs (interval cancer, IC) still occur. Recent studies demonstrated that protection by colonoscopy against right-sided colon cancer was lower than that attained in the left colon. Adenoma detection rate (ADR) has been correlated with IC - each 1 % increase in ADR is associated with 3% decrease in the risk of ICs. Hopefully, innovations that improve right colon ADR would reduce the right colon IC. Insertion water exchange (WE), characterized by infusing water to guide the advance of the colonoscope in an airless lumen with its removal mainly during insertion. WE has been shown to improve the overall and right colon ADR compared to traditional air insufflation (Air). Several plausible causes have been proposed to explain the enhanced ADR by WE, including decreased multitasking related distraction, improved bowel cleanness, and flat polyps appearing less flatten and floating up in water Therefore, the adoption of WE in the right colon might be especially beneficial. In addition, WE has been criticized for prolonged insertion time, about 3-5 minutes longer than Air to reach the cecum and required a learning curve of about 50 to 100 cases.In this study, we devise a right colon WE method (RCWE), in which Air will be used to intubate to the hepatic flexure, followed by WE in the right colon. We test the hypothesis that RCWE would increase the right colon ADR without prolonging the insertion time. Consecutive patients undergoing screening, surveillance, or diagnostic examinations performed by participating endoscopists will be stratified for enrollment. Patients will be randomized in a 1:1 ratio (n=207 per group) to either the AI or RCWE group. Demographic data (age, gender, height, and weight), indications for colonoscopy, history of abdominal or pelvic surgery, constipation and chronic use of laxatives will be ascertained before colonoscopy. Quality of bowel preparation, cecal intubation time, withdrawal time, total procedure time, use of abdominal compression, need for change of position, presence and location of polyps and reasons for incomplete colonoscopy will be recorded. In addition, the right colon (from the hepatic flexure to cecum) insertion time and withdrawal time and infused and suction water amount will be recorded separately.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
414

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

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

June 9, 2020

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
Last Updated

June 22, 2026

Status Verified

March 1, 2026

Enrollment Period

5.6 years

First QC Date

March 3, 2026

Last Update Submit

June 18, 2026

Conditions

Keywords

water exchange colonoscopyRight colon adenoma detection ratecolonoscopy

Outcome Measures

Primary Outcomes (1)

  • adenoma detection rate in proximal colon

    The proportion of patients with the presence of adenoma in the proximal colon.

    one week

Secondary Outcomes (1)

  • adenoma detection rate

    one week

Other Outcomes (1)

  • Insertion time

    During the procedure.

Study Arms (2)

Right colon water exchange group

EXPERIMENTAL

Air insufflation was used to advance the colonoscope to the hepatic flexure, where the insertion method was switched to water exchange (WE) to reach the cecum. This predefined transition was designed to specifically evaluate the effect of WE on right-sided colon adenoma detection.

Behavioral: Right colon water exchange

Air insufflation group

ACTIVE COMPARATOR

Cecal intubation was achieved using conventional air insufflation.

Behavioral: Air nsufflation

Interventions

Air insufflation was used to advance the colonoscope to the hepatic flexure, where the insertion method was switched to water exchange (WE) to reach the cecum. This predefined transition was designed to specifically evaluate the effect of WE on right-sided colon adenoma detection.Air insufflation was applied during withdrawal in both groups.

Right colon water exchange group
Air nsufflationBEHAVIORAL

Behavioral: Air nsufflationAir was used to minimally distend the lumen during insertion. Water (30-50 mL aliquots) was delivered via syringe as needed to clear residual stool. Carbon dioxide was not used, as it is not standard practice for colonoscopy in Taiwan. Air insufflation was applied during withdrawal in both groups.

Air insufflation group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 40 to 80 years.
  • Patients undergoing screening, surveillance, or diagnostic colonoscopy.
  • Colonoscopy performed by participating endoscopists.
  • Ability to provide written informed consent.

You may not qualify if:

  • Inability or unwillingness to provide informed consent.
  • Age \< 40 years or \> 80 years.
  • History of colorectal surgery (e.g., partial colectomy).
  • Known or suspected colorectal cancer.
  • Known inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease).
  • Planned therapeutic colonoscopy (e.g., polypectomy).
  • Inadequate bowel preparation.
  • Known or suspected colonic obstruction or severe stricture.
  • Massive ascites.
  • Severe comorbid conditions (e.g., renal failure).
  • Emergency colonoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Chiayi City, Chiayi, 62247, Taiwan

Location

Related Publications (19)

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  • Kudo Se, Lambert R, Allen JI, Fujii H, Fujii T, Kashida H, Matsuda T, Mori M, Saito H, Shimoda T, Tanaka S, Watanabe H, Sung JJ, Feld AD, Inadomi JM, O'Brien MJ, Lieberman DA, Ransohoff DF, Soetikno RM, Triadafilopoulos G, Zauber A, Teixeira CR, Rey JF, Jaramillo E, Rubio CA, Van Gossum A, Jung M, Vieth M, Jass JR, Hurlstone PD. Nonpolypoid neoplastic lesions of the colorectal mucosa. Gastrointest Endosc. 2008 Oct;68(4 Suppl):S3-47. doi: 10.1016/j.gie.2008.07.052. No abstract available.

  • The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002. Gastrointest Endosc. 2003 Dec;58(6 Suppl):S3-43. doi: 10.1016/s0016-5107(03)02159-x. No abstract available.

  • Ramirez FC, Leung FW. The water method for aiding colonoscope insertion: the learning curve of an experienced colonoscopist. J Interv Gastroenterol. 2011 Jul;1(3):97-101. doi: 10.4161/jig.1.3.18507. Epub 2011 Jul 1.

  • Fischer LS, Lumsden A, Leung FW. Water exchange method for colonoscopy: learning curve of an experienced colonoscopist in a U.S. community practice setting. J Interv Gastroenterol. 2012 Jul;2(3):128-132. doi: 10.4161/jig.23734. Epub 2012 Jul 1.

  • Hsieh YH, Koo M, Tseng CW, Yang HW, Leung FW. Reduction of multitasking distractions underlies the higher adenoma detection rate of water exchange compared to air insufflation - blinded analysis of withdrawal phase videos. United European Gastroenterol J. 2019 Mar;7(2):230-238. doi: 10.1177/2050640618817105. Epub 2018 Dec 5.

  • Fuccio L, Frazzoni L, Hassan C, La Marca M, Paci V, Smania V, De Bortoli N, Bazzoli F, Repici A, Rex D, Cadoni S. Water exchange colonoscopy increases adenoma detection rate: a systematic review with network meta-analysis of randomized controlled studies. Gastrointest Endosc. 2018 Oct;88(4):589-597.e11. doi: 10.1016/j.gie.2018.06.028. Epub 2018 Jul 5.

  • Hsieh YH, Koo M, Leung FW. A patient-blinded randomized, controlled trial comparing air insufflation, water immersion, and water exchange during minimally sedated colonoscopy. Am J Gastroenterol. 2014 Sep;109(9):1390-400. doi: 10.1038/ajg.2014.126. Epub 2014 Jun 3.

  • Jia H, Pan Y, Guo X, Zhao L, Wang X, Zhang L, Dong T, Luo H, Ge Z, Liu J, Hao J, Yao P, Zhang Y, Ren H, Zhou W, Guo Y, Zhang W, Chen X, Sun D, Yang X, Kang X, Liu N, Liu Z, Leung F, Wu K, Fan D. Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial. Am J Gastroenterol. 2017 Apr;112(4):568-576. doi: 10.1038/ajg.2016.501. Epub 2016 Dec 6.

  • Hsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15.

  • Cadoni S, Falt P, Rondonotti E, Radaelli F, Fojtik P, Gallittu P, Liggi M, Amato A, Paggi S, Smajstrla V, Urban O, Erriu M, Koo M, Leung FW. Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial. Endoscopy. 2017 May;49(5):456-467. doi: 10.1055/s-0043-101229. Epub 2017 Mar 10.

  • Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.

  • Rondagh EJ, Bouwens MW, Riedl RG, Winkens B, de Ridder R, Kaltenbach T, Soetikno RM, Masclee AA, Sanduleanu S. Endoscopic appearance of proximal colorectal neoplasms and potential implications for colonoscopy in cancer prevention. Gastrointest Endosc. 2012 Jun;75(6):1218-25. doi: 10.1016/j.gie.2012.02.010. Epub 2012 Apr 5.

  • Gupta S, Balasubramanian BA, Fu T, Genta RM, Rockey DC, Lash R. Polyps with advanced neoplasia are smaller in the right than in the left colon: implications for colorectal cancer screening. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1395-1401.e2. doi: 10.1016/j.cgh.2012.07.004. Epub 2012 Jul 24.

  • Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.

  • Doubeni CA, Weinmann S, Adams K, Kamineni A, Buist DS, Ash AS, Rutter CM, Doria-Rose VP, Corley DA, Greenlee RT, Chubak J, Williams A, Kroll-Desrosiers AR, Johnson E, Webster J, Richert-Boe K, Levin TR, Fletcher RH, Weiss NS. Screening colonoscopy and risk for incident late-stage colorectal cancer diagnosis in average-risk adults: a nested case-control study. Ann Intern Med. 2013 Mar 5;158(5 Pt 1):312-20. doi: 10.7326/0003-4819-158-5-201303050-00003.

  • Baxter NN, Warren JL, Barrett MJ, Stukel TA, Doria-Rose VP. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol. 2012 Jul 20;30(21):2664-9. doi: 10.1200/JCO.2011.40.4772. Epub 2012 Jun 11.

  • Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.

  • Dekker E, Rex DK. Advances in CRC Prevention: Screening and Surveillance. Gastroenterology. 2018 May;154(7):1970-1984. doi: 10.1053/j.gastro.2018.01.069. Epub 2018 Feb 15.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 6, 2026

Study Start

June 9, 2020

Primary Completion

December 31, 2025

Study Completion

January 30, 2026

Last Updated

June 22, 2026

Record last verified: 2026-03

Locations