Endoscopic Retrograde Appendicitis Therapy

NCT04281251 | Completed DMC

• 1 other identifier: CRE-2020.011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective pilot study on the efficacy of endoscopic therapy for adult uncomplicated acute appendicitis. In recent years, antibiotics treatment has been a new alternative approach to surgical appendicectomy for acute appendicitis, however, there is a risk of failed antibiotics treatment and chance of recurrent appendicitis. Endoscopic therapy of acute appendicitis (ERAT) has been recently described that involves colonoscopic insertion of plastic stent and removal of appendicolith. The investigators conduct this pilot study to investigate the feasibility, technical and clinical success rate of endoscopic retrograde appendicitis therapy among adult patients with uncomplicated acute appendicitis. 20 patients would be recruited for the pilot study.

Conditions

Acute Appendicitis

Keywords

appendicitis; endoscopic drainage

Outcome Measures

Primary Outcomes (1)

• Clinical success rate

  defined as completion of both endoscopic procedures without need for surgery or complications related to acute appendicitis

  30 days

Secondary Outcomes (4)

• Technical success rate

  30 days

• Rate of recurrent acute appendicitis, up to 1 year of index attack

  1 year

• Rate of adverse events related to endoscopic procedures

  30 days

• Scale of post-operative pain

  7 days

Study Arms (1)

ERAT arm

EXPERIMENTAL

This is the treatment arm where endoscopic therapy of acute appendicitis would be performed

Procedure: Endoscopic retrograde appendicitis therapy

Interventions

Endoscopic retrograde appendicitis therapy PROCEDURE

Colonoscopy would be introduced until visualization of the appendiceal orifice. Catheter would be placed in the appendix and decompression performed. After removal of appendicolith, plastic stent would be placed for drainage of appendix. For patients successfully treated with initial endoscopic drainage, they would be re-admitted at 1 weeks after index procedure for repeat colonoscopy. After reaching the appendiceal orifice, the previous plastic stent would be removed. A contrast appendicogram would be repeated by introducing a wire-guided catheter in the appendix, and any residual fecalith would be removed. Finally, a repeat contrast appendicogram would be performed to confirm complete clearance of fecalith.

ERAT arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients emergency admitted for suspected acute appendicitis
• Age 18 - 70
• Computed Tomography of the abdomen with contrast confirmed uncomplicated appendicitis, as evidenced by presence of a dilated, thickened wall appendix without perforation, abscess or gangrene.

You may not qualify if:

• History of previous appendicitis
• Evidence of perforation, abscess or gangrene of appendix on CT scan
• Significant paralytic ileus as evidenced by dilated bowel loops on imaging
• Evidence of co-existing acute surgical pathologies on the CT scan
• Allergic to bowel preparation solution (Polyethylene glycol)
• Marked electrolyte abnormalities, significant renal impairment (CrCl \<30ml/min)
• Coagulopathy (INR \>1.5, platelet \<50)
• Pregnancy, or contraindication to fluoroscopy
• Other cases deemed by the examining physician as unsuitable for safe treatment
• Refusal to participate

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Model Details: Single arm case series

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)