Diagnosis of Upper Gastrointestinal submucosal Lesions

Endoscopic ultrasound guided 22-gauge fine needle biopsy versus single-incision with needle knife for the diagnosis of upper gastrointestinal subepithelial lesions in a tertiary care centre in eastern India: a single blind randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057372

Enrollment

Registered

2023-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Health Condition 1: K929- Disease of digestive system, unspecified

Interventions

Intervention1: Single incision needle knife (SINK): Under endoscopic vision single incision is made over mucosa to expose the submucosal lesion and tissue sample is obtained by biopsy forceps and the

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients of age >18years with upper GI subepithelial lesions having maximum diameter of 15mm or more diagnosed on endoscopy by standard biopsy forceps

Exclusion criteria

Exclusion criteria: 1. Non-consenting patients 2. 3. Those needed emergency surgical intervention. 4. Varices, lipomas 5. Cysts 6. Aneurysms 7. Exophytic lesion 8. Serosal lesion 9. Extrinsic compression 10. Uncorrectable coagulopathy (INR >1.5 or platelet count 11. Patients with stigmata of portal hypertension 12. Post-surgical altered upper GI anatomy (Roux-en-Y gastric bypass, esophagectomy etc) 13. Pregnant Patients

Design outcomes

Primary

Measure	Time frame
To compare diagnostic accuracy of endoscopic ultrasound guided-fine needle biopsy and single incision needle biopsy Timepoint: 16 months	—

Secondary

Measure	Time frame
a. To compare histological yield b. Technical failure (inability to complete 3 assigned passes as determined by randomization) c. Adverse effects with their severity being rated according to ASGE lexicon d. Procedure duration (time from the beginning of the incision or needle insertion, to completion of tissue acquisition per protocol) e. Prevalance of different eitiologies in our centre f. Contribution of immunohistochemistry (when needed) between 2 techniques Timepoint: 12 months	—

Measure

Time frame

a. To compare histological yield b. Technical failure (inability to complete 3 assigned passes as determined by randomization) c. Adverse effects with their severity being rated according to ASGE lexicon d. Procedure duration (time from the beginning of the incision or needle insertion, to completion of tissue acquisition per protocol) e. Prevalance of different eitiologies in our centre f. Contribution of immunohistochemistry (when needed) between 2 techniques Timepoint: 12 months

—

Countries

India

Contacts

Public ContactDr Biswadeep Roy

IPGMER, Kolkata

debcnmch@yahoo.com9830472292

Outcome results

None listed

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