The Prevalence of Appendiceal Tumours in Periappendicular Abscess

Appendicitis Clinical Trial

— PeriAPPAC-T  

Official title:

The Prevalence of Appendiceal Tumours in Patients Presenting With a Periappendicular Abscess - A Nationwide Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04634448
• Other study ID #: PeriAPPAC-T
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2035

Study information

• Verified date: November 2020
• Source: Turku University Hospital
• Contact: Paulina Salminen, prof, MD
• Phone: +35823130000
• Email: paulina.salminen[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Complicated and uncomplicated appendicitis follow different epidemiological trends also suggesting different pathophysiology behind these two different forms of appendicitis. In 3-10% of patients complicated acute appendicitis is enclosed by formation of a circumscribed periappendicular abscess. The clinically established practice of antibiotic therapy and drainage, if necessary, has been shown safe and effective, allowing the acute inflammatory process to subside in more than 90% of cases without surgery. The need of subsequent interval appendectomy has been questioned with appendicitis recurrence risk varying between 5-26%. During trial enrollment in our randomized Peri-APPAC trial based on the interim analysis results with 17% appendiceal tumor rate in the study population, the trial was prematurely terminated based on ethical concerns. All the follow-up group patients were re-evaluated and surgery was offered and recommended to all follow-up group patients. After this assessment and additional appendectomies, two more tumors were diagnosed resulting in neoplasm rate of 20% in the whole study group all diagnosed in patients over 40 years and the neoplasm rate in patients over 40 years was 29%. Based on high appendiceal tumor rate in patients over 40 years, the appendiceal neoplasm rate needs to be further evaluated in prospective patient cohorts undergoing interval appendectomy as interval appendectomy is generally well tolerated and obliterates the risk of missing a possible tumor. In a recent systematic review of retrospective cohort studies with 13.244 acute appendicitis patients the overall appendiceal tumor rate was 1% after appendectomy, but in patients presenting with appendiceal inflammatory mass the neoplasm rate varied from 10% to 29%. This nationwide prospective multicenter cohort study is designed to assess the prevalence of appendiceal tumors associated with a periappendicular abscess. All consecutive patients presenting with a periappendicular abscess are recommended to undergo interval appendectomy after initial conservative treatment with antibiotic therapy and drainage, if necessary. All patients older than 35 years will undergo laparoscopic interval appendectomy at 2 to 3 months and this is also recommended for the patients between 18 and 35 years of age. Asymptomatic patients under 35 years not willing to undergo interval appendectomy, will undergo a follow-up MRI at 1 year after the initial non-operative treatment.

Description:

Complicated and uncomplicated appendicitis follow different epidemiological trends also suggesting different pathophysiology behind these two different forms of appendicitis. In 3-10% of patients complicated acute appendicitis is enclosed by formation of a circumscribed periappendicular abscess. The clinically established practice of antibiotic therapy and drainage, if necessary, has been shown safe and effective, allowing the acute inflammatory process to subside in more than 90% of cases without surgery. The need of subsequent interval appendectomy has been questioned with appendicitis recurrence risk varying between 5-26%. During trial enrollment in our randomized Peri-APPAC trial, the high incidence of appendiceal tumors in the study population alarmed the researchers. Based on the interim analysis results with 17% appendiceal tumor rate in the study population, the trial was prematurely terminated based on ethical concerns. All the follow-up group patients were re-evaluated and surgery was offered and recommended to all follow-up group patients. After this assessment and additional appendectomies, two more tumors were diagnosed resulting in neoplasm rate of 20% in the whole study group all diagnosed in patients over 40 years and the neoplasm rate in patients over 40 years was 29%. Based on high appendiceal tumor rate in patients over 40 years, the appendiceal neoplasm rate needs to be further evaluated in prospective patient cohorts undergoing interval appendectomy as interval appendectomy is generally well tolerated and obliterates the risk of missing a possible tumor. In a recent systematic review of retrospective cohort studies with 13.244 acute appendicitis patients the overall appendiceal tumor rate was 1% after appendectomy, but in patients presenting with appendiceal inflammatory mass the neoplasm rate varied from 10% to 29%. This nationwide prospective multicenter cohort study is designed to assess the prevalence of appendiceal tumors associated with a periappendicular abscess. All of the study hospitals will have a common clinical protocol of recommending interval appendectomy to all patients presenting with a periappendicular abscess after initial conservative treatment with antibiotic therapy and drainage, if necessary. Considering the high rate of appendiceal neoplasms, all patients older than 35 years will undergo laparoscopic interval appendectomy at 2 to 3 months after the successful initial non-operative treatment and this is also recommended for the patients between 18 and 35 years of age. Asymptomatic patients under 35 years not willing to undergo interval appendectomy, will undergo a follow-up MRI at 1 year after the initial non-operative treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• periappendiceal abscess proven by CT, Mri or US

Exclusion Criteria:

• patient declines to participate, complicated appendicitis without periappendiceal abscess

Related Conditions & MeSH terms

• Abscess
• Appendiceal Neoplasms
• Appendicitis
• Appendix Abscess
• Appendix Cancer
• Appendix Diseases
• Appendix Mass
• Appendix Nec
• Appendix Tumor

Intervention

Procedure:
• Interval appendectomy
interval appendectomy at 2 to 3 months after the initial non-operative treatment

Diagnostic Test:
• Follow-up MRI at 1 year
follow-up MRI at 1 year for asymptomatic patients under 35 years of age not wanting to undergo surgery

Locations

Country	Name	City	State
n/a

Sponsors (13)

Lead Sponsor	Collaborator
Turku University Hospital	Jyväskylä Central Hospital, Kuopio University Hospital, Lapland Central Hospital, Mikkeli Central Hospital, North Karelia Central Hospital, Oulu University Hospital, Päijänne Tavastia Central Hospital, Satakunta Central Hospital, Seinajoki Central Hospital, South Carelia Central Hospital, Tampere University Hospital, Vaasa Central Hospital, Vaasa, Finland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Prevalence of Appendiceal Tumours in Periappendicular Abscess	The Prevalence of Appendiceal Tumours in Patients Presenting With a Periappendicular Abscess - A Nationwide Prospective Cohort Study	2-3 months (interval appendectomy)
Secondary	Tympanic temperature	All patients	Day 0 (on primary admission)
Secondary	Imaging (primary diagnosis) finding	All patients	Day 0 (on primary admission)
Secondary	Duration of symptoms on admission	All patients	Day 0 (on primary admission)
Secondary	Laboratory value: CRP	CRP	Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Secondary	Laboratory value: leuckocytes	leuk	Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Secondary	Laboratory value: neutrophils	neutr	Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Secondary	Laboratory value: hemoglobin	Hb	Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Secondary	Laboratory value: kreatinine	Krea	Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)
Secondary	Laboratory value: CEA	CEA	Day 0 (on primary admission) up to 3-5 days (discharge from the hospital) and up to 1 year, if no interval appendectomy
Secondary	Laboratory value. Cg-A	Cg-A	Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)and up to 1 year, if no interval appendectomy
Secondary	Primary nonoperative treatment	All patients, treatment details	Day 0 and up to one week
Secondary	Colonoscopy: endoscopic findings and histology	In both intervention groups	2 weeks to 2 months prior to planned interval appendectomy
Secondary	Interval appendectomy specimen histology	Interval appendectomy patients	At 3 months
Secondary	Complications after interval appendectomy	Clavien-Dindo classification, interval appendectomy group	at the time of surgery
Secondary	Duration of hospital stay	All patients both at primary treatment, interval appendectomy and follow-up	up to 2 years
Secondary	Follow-up MRI findings	In case the patient does not under interval appendectomy	at 1 year
Secondary	follow-up CEA	Follow-up MRI patients	at 1 year
Secondary	follow-up CgA	Follow-up MRI patients	at 1 year
Secondary	Surgery after follow-up MRI	Follow-up with MRI patients	up to 10 years