Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-28 @ 10:35 PM
Study NCT ID:
NCT04281251
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Retrograde Appendicitis Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm case series'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success rate', 'timeFrame': '30 days', 'description': 'defined as completion of both endoscopic procedures without need for surgery or complications related to acute appendicitis'}], 'secondaryOutcomes': [{'measure': 'Technical success rate', 'timeFrame': '30 days', 'description': 'defined as successful completion of both endoscopic procedures'}, {'measure': 'Rate of recurrent acute appendicitis, up to 1 year of index attack', 'timeFrame': '1 year', 'description': 'defined as recurrent diagnosis of acute appendicitis'}, {'measure': 'Rate of adverse events related to endoscopic procedures', 'timeFrame': '30 days', 'description': 'Rate of adverse events, graded according to Common Terminology Criteria for Adverse Events.'}, {'measure': 'Scale of post-operative pain', 'timeFrame': '7 days', 'description': 'Graded by Visual Analogue Scale from 0-10, (10 being the most painful) from Day 1 to 7'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['appendicitis', 'endoscopic drainage'], 'conditions': ['Acute Appendicitis']}, 'descriptionModule': {'briefSummary': '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.\n\nEndoscopic 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.', 'detailedDescription': '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.\n\nEndoscopic 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.\n\nGiven 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Adult patients emergency admitted for suspected acute appendicitis\n2. Age 18 - 70\n3. 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.\n\nExclusion criteria\n\n1. History of previous appendicitis\n2. Evidence of perforation, abscess or gangrene of appendix on CT scan\n3. Significant paralytic ileus as evidenced by dilated bowel loops on imaging\n4. Evidence of co-existing acute surgical pathologies on the CT scan\n5. Allergic to bowel preparation solution (Polyethylene glycol)\n6. Marked electrolyte abnormalities, significant renal impairment (CrCl \\<30ml/min)\n7. Coagulopathy (INR \\>1.5, platelet \\<50)\n8. Pregnancy, or contraindication to fluoroscopy\n9. Other cases deemed by the examining physician as unsuitable for safe treatment\n10. Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04281251', 'briefTitle': 'Endoscopic Retrograde Appendicitis Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Endoscopic Retrograde Appendicitis Therapy - a Pilot Study', 'orgStudyIdInfo': {'id': 'CRE-2020.011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERAT arm', 'description': 'This is the treatment arm where endoscopic therapy of acute appendicitis would be performed', 'interventionNames': ['Procedure: Endoscopic retrograde appendicitis therapy']}], 'interventions': [{'name': 'Endoscopic retrograde appendicitis therapy', 'type': 'PROCEDURE', '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.\n\nFor 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.', 'armGroupLabels': ['ERAT arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Consultant', 'investigatorFullName': 'Hon Chi Yip', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}