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A randomized controlled trial on the usefulness of underwater endoscopic submucosal dissection (ESD) versus conventional ESD for colorectal tumors

A randomized controlled trial on the usefulness of underwater endoscopic submucosal dissection (ESD) versus conventional ESD for colorectal tumors - A randomized controlled trial on the usefulness of underwater endoscopic submucosal dissection (ESD) versus conventional ESD for colorectal tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038529
Enrollment
140
Registered
2019-11-10
Start date
2019-11-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal tumor

Interventions

Underwater ESD group Conventional ESD group

Sponsors

Shonan Fujisawa Tokushukai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Colorectal tumors that are difficult to resect by EMR 2) No recurrent lesion after an endoscopic treatment 3) No complication such as inflammatory bowel disease 4) Lesion does not extend to the appendix or ileum 5) Written informed consent by the patient 6) Patient age between 20 and 94 years

Exclusion criteria

Exclusion criteria: 1) Pregnant patients or with the possibility of the pregnancy 2) Lactating patients 3) Patients disqualified for this study by the physician 4) Patients who have participated in this study

Design outcomes

Primary

MeasureTime frame
Dissection speed

Secondary

MeasureTime frame
Total volume of injection solution used during the ESD procedure; perforation rate; Frequency of the intraoperative bleeding that requires hemostatic forceps; Post-ESD bleeding rate; Post-ESD coagulation syndrome rate; Variation in white blood cell count, blood CRP level, and blood Na level on the day of and the day after the ESD procedure; Time required to create the mucosal flap; Frequency of UESD interruptions due to bleeding; Time required to return to UESD post-UESD interruption due to bleeding; Frequency of CESD interruptions due to bleeding; Time required to return to CESD post-CESD interruption due to bleeding; Dissection speed according to the lesion location; ESD procedure time according to the lesion location; Dissection speed according to the presence of fibrosis; ESD procedure time according to the presence of fibrosis; Dissection speed according to the positional relationship with gravity; Time for the ESD procedure according to the positional relationship with gravity

Countries

Japan

Contacts

Public ContactMitsuru Nagata

Shonan Fujisawa Tokushukai Hospital Department of Endoscopy

mitsuru10jp@yahoo.co.jp0466351177

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026