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A multicenter, prospective study of self-help inflatable balloons for the prevention and treating benign esophageal strictures

A multicenter, prospective study of self-help inflatable balloons for the prevention and treating benign esophageal strictures

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067553
Enrollment
Unknown
Registered
2023-01-11
Start date
2019-01-28
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

benign esophageal strictures

Interventions

Experimental group (prevent)):Placement of self-help inflatable balloons
Experimental group(Treatment):Placement of self-help inflatable balloons

Sponsors

The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Preventing esophageal stricture: (1)The predicted esophageal postoperative mucosal defect was at least >3/4 circumference. (2) lesion length >3 cm; lesion depth did not exceed the submucosa (sm1); (3) complete resection of the esophageal lesion; (4) Age between 18 and 90 years; (5) informed consent for endoscopic treatment and related operations. Treating benign refractory esophageal stricture(1) benign strictures caused by surgery, endoscopic resection, and custic, etc.; (2) dysphagia score = 2; (3) standard gastroscopy (9-11 mm) with cannot pass; (4) no recurrence under endoscopic observation; (5) stricture length = 8 cm

Exclusion criteria

Exclusion criteria: (1) poor compliance in the study; (2) need to receive other treatment affecting this study due to other diseases during the study; (3) combined anastomotic fistula; (4) anastomosis with erosion, ulceration, bleeding, etc.; (5) withdrawal from the study initiated by the subject or the surrogate; (6) those are not suitable to continue to participate

Design outcomes

Primary

MeasureTime frame
stricture rate;days of placing balloon;

Secondary

MeasureTime frame
Perforation rate;bleeding rate;stricture length;stricture diameter;Location;

Countries

China

Contacts

Public ContactChai Ningli

The First Medical Center of Chinese PLA General Hospital

chainingli@vip.163.com17346523979

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026