Evaluation of sodium carboxymethyl cellulose (SCMC) and hyaluronic acid (HA) as a local injection solution of endoscopic submucosal dissection for early gastric cancer;Randomized controlled trial

Evaluation of sodium carboxymethyl cellulose (SCMC) and hyaluronic acid (HA) as a local injection solution of endoscopic submucosal dissection for early gastric cancer;Randomized controlled trial - RCT of ESD with SCMC or HA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015382

Enrollment

Registered

2014-10-14

Start date

2014-10-12

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

Early gastric cancer and gastric adenoma

Interventions

Using SCMC as a for submucosal injection solution. Using HA as a for submucosal injection solution.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient who will be performed ESD for gastric cancer or gastric adenoma. 2. Gastric neoplasms with indication of ESD. 3. Patient has no history of allergy to SCMC or HA. 4. ECOG performance status is 0 or 1 or 2. 5. Patient must sign an informed consent.

Exclusion criteria

Exclusion criteria: 1.Psychosis 2.Patient who have synchronous lesion 3. Patients who cannot consent to use SCMC. 4. Patient with AP, Respiratory failure, Chronic hepatitis, Renal failure requiring dialysis, simultaneous cancer, continuous systemic steroid medication. 5. Patients with allergy to SCMC and HA. 6.Patients temporary interruption of antiplatlet agents and anticoagulants is not possible. 7.Patient under heparin replacement. 8.Patient who have been judged as psychotic manifestation.

Design outcomes

Primary

Measure	Time frame
procedural time	—

Secondary

Measure	Time frame
1.The amount of local injection solution of HA or SCMC 2.Number of times of use of hemostatic forceps for stop bleeding 3.Status of ulcer healing 4.Bleeding rate 5.Incidence rate of adverse events related to ESD 6.En block resection rate 7.R0 resection rate 8.Blood test: WBC,CRP (next day) 9.Changes in body temperature 10.Evaluate of technically difficult (evaluated at 10 levels with a VAS score) (10point: very easy, 1point: very difficult) 11.Change of local injection solution 12.Change of the operator	—

Measure

Time frame

1.The amount of local injection solution of HA or SCMC 2.Number of times of use of hemostatic forceps for stop bleeding 3.Status of ulcer healing 4.Bleeding rate 5.Incidence rate of adverse events related to ESD 6.En block resection rate 7.R0 resection rate 8.Blood test: WBC,CRP (next day) 9.Changes in body temperature 10.Evaluate of technically difficult (evaluated at 10 levels with a VAS score) (10point: very easy, 1point: very difficult) 11.Change of local injection solution 12.Change of the operator

—

Countries

Japan

Contacts

Public ContactNakamura Jun

Fukushima medical university Endoscopy division

junn7971@fmu.ac.jp024-547-1583

Outcome results

None listed

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