Endoscopic Retrograde Appendicitis Therapy
Primary Purpose
Acute Appendicitis
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Endoscopic retrograde appendicitis therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Appendicitis focused on measuring appendicitis, endoscopic drainage
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ERAT arm
Arm Description
This is the treatment arm where endoscopic therapy of acute appendicitis would be performed
Outcomes
Primary Outcome Measures
Clinical success rate
defined as completion of both endoscopic procedures without need for surgery or complications related to acute appendicitis
Secondary Outcome Measures
Technical success rate
defined as successful completion of both endoscopic procedures
Rate of recurrent acute appendicitis, up to 1 year of index attack
defined as recurrent diagnosis of acute appendicitis
Rate of adverse events related to endoscopic procedures
Rate of adverse events, graded according to Common Terminology Criteria for Adverse Events.
Scale of post-operative pain
Graded by Visual Analogue Scale from 0-10, (10 being the most painful) from Day 1 to 7
Full Information
NCT ID
NCT04281251
First Posted
February 20, 2020
Last Updated
February 7, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04281251
Brief Title
Endoscopic Retrograde Appendicitis Therapy
Official Title
Endoscopic Retrograde Appendicitis Therapy - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Acute appendicitis is one of the most common surgical emergencies in adult patients. The lifetime risk of developing acute appendicitis in the United States is 8.6% for males and 6.7% for females. For many decades, surgical appendicectomy is the gold standard of treatment of acute appendicitis. Appendicectomy could be performed in an open manner via a right lower abdominal incision, or more popular nowadays with the laparoscopic approach by placing three abdominal trocars. Earlier studies have identified high treatment success rate with both open and laparoscopic approaches, but adverse events were lower in laparoscopic group. Intra-abdominal abscesses were a potential concern with laparoscopic appendicectomy. In recent few years, antibiotics treatment for acute appendicitis has been a promising management option. By avoid the need of surgery and general anaesthesia, the non-operative approach was associated with a lower morbidity than the surgical approach. The major drawback of antibiotic treatment was the risk of failed primary treatment and subsequent recurrent appendicitis. A recent randomized controlled study demonstrated a primary clinical success treatment at index attack of 94.2%. 72.7% of the patients who received antibiotics alone did not require appendicectomy at 1-year follow-up. While antibiotics therapy could be a safe alternative to surgical therapy, many are still skeptical of the treatment due to the potential high recurrence rate.
Endoscopic therapy of acute appendicitis (Endoscopic retrograde appendicitis therapy, ERAT) was recently described recently in the literature. The technique involves a two-staged procedure with endoscopic plastic stent drainage of appendiceal orifice followed by stent and appendicolith retrieval. These were small case series conducted in China demonstrating technical feasibility and initial clinical success rate of this alternative approach. The technique has not been practiced in most centers across the world. The merit of endoscopic treatment lies in its potential to remove the appendicolith thereby reducing the recurrence rate. It could provide an invaluable treatment option that overcomes the drawback of high recurrence rate with antibiotics alone.
Given that the novel endoscopic technique has not been widely adopted, the investigators plan to 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis
Keywords
appendicitis, endoscopic drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERAT arm
Arm Type
Experimental
Arm Description
This is the treatment arm where endoscopic therapy of acute appendicitis would be performed
Intervention Type
Procedure
Intervention Name(s)
Endoscopic retrograde appendicitis therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical success rate
Description
defined as completion of both endoscopic procedures without need for surgery or complications related to acute appendicitis
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Technical success rate
Description
defined as successful completion of both endoscopic procedures
Time Frame
30 days
Title
Rate of recurrent acute appendicitis, up to 1 year of index attack
Description
defined as recurrent diagnosis of acute appendicitis
Time Frame
1 year
Title
Rate of adverse events related to endoscopic procedures
Description
Rate of adverse events, graded according to Common Terminology Criteria for Adverse Events.
Time Frame
30 days
Title
Scale of post-operative pain
Description
Graded by Visual Analogue Scale from 0-10, (10 being the most painful) from Day 1 to 7
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
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.
Exclusion criteria
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
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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Endoscopic Retrograde Appendicitis Therapy
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