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Acute AppendicitisNCT04281251

Endoscopic Retrograde Appendicitis Therapy

A study testing Endoscopic retrograde appendicitis therapy in people with Acute Appendicitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Appendicitis
What is being tested?
Endoscopic retrograde appendicitis therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteHong Kong
Study dates
1 Jun 2020to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • The Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Endoscopic Retrograde Appendicitis Therapy - a Pilot Study

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.

Read the 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.

Being tested
Endoscopic retrograde appendicitis therapy
Keywords
appendicitis, endoscopic drainage
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic retrograde appendicitis therapyProcedure or surgery

    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.

Study groups in NCT04281251
Study groupRoleWhat they receive
ERAT armExperimentalThis is the treatment arm where endoscopic therapy of acute appendicitis would be performed
Receives: Procedure: Endoscopic retrograde appendicitis therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical success rate

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

    Measured: 30 days

Secondary outcomes (4)
  1. Technical success rate

    defined as successful completion of both endoscopic procedures

    Measured: 30 days

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

    defined as recurrent diagnosis of acute appendicitis

    Measured: 1 year

  3. Rate of adverse events related to endoscopic procedures

    Rate of adverse events, graded according to Common Terminology Criteria for Adverse Events.

    Measured: 30 days

  4. Scale of post-operative pain

    Graded by Visual Analogue Scale from 0-10, (10 being the most painful) from Day 1 to 7

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2020
  2. Study start1 Jun 2020
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm case series
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04281251
Sponsor's protocol ID
CRE-2020.011
Status last verified
Feb 2023
First submitted
20 Feb 2020
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic retrograde appendicitis therapy in people with Acute Appendicitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical success rate (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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