Comparing two types of tube feeding in patients with severe swallowing difficulties

A prospective randomized trial comparing percutaneous endoscopic gastrostomy to radiologically inserted percutaneous gastrostomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17642761

Enrollment

180

Registered

2022-01-04

Start date

2014-10-01

Completion date

Unknown

Last updated

2023-03-13

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

Conditions

Severe dysphagia Signs and Symptoms Dysphagia

Interventions

Participants are randomly allocated 1:1 in blocks of 10 with closed envelopes to undergo percutaneous endoscopic gastrostomy (PEG) or radiologically inserted gastrostomy (RIG) and are followed up at 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients referred to the department for a feeding gastrostomy due to severe dysphagia, and eligible for both methods (PEG/RIG)

Exclusion criteria

Exclusion criteria: Inability to perform an endoscopy due to pharyngo-esophageal obstruction, total or subtotal gastrectomy, other major upper-abdominal surgery, peritoneal carcinosis or ascites

Design outcomes

Primary

Measure	Time frame
Overall complication rate and major and minor complications occurring early (within 10 days) or late (11-30 days) after gastrostomy placement. Major complications are defined as conditions in potential need of reoperation or cardiovascular support, e.g., gastrointestinal perforations, intrabdominal bleeding, aspiration pneumonia or myocardial infarction, while local and self-limiting problems are to be classified as minor.	—

Measure

Time frame

Overall complication rate and major and minor complications occurring early (within 10 days) or late (11-30 days) after gastrostomy placement. Major complications are defined as conditions in potential need of reoperation or cardiovascular support, e.g., gastrointestinal perforations, intrabdominal bleeding, aspiration pneumonia or myocardial infarction, while local and self-limiting problems are to be classified as minor.

—

Secondary

Measure	Time frame
Patient-scored health status measured by EQ-5D (EuroQol Research Foundation) at baseline and at 10 and 30 days postoperatively	—

Countries

Sweden

Contacts

Public ContactMagnus Sundbom

magnus.sundbom@surgsci.uu.se+46 (0)705432989

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026