A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy

Familial Adenomatous Polyposis Clinical Trial

Official title:

A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04678011
• Other study ID #: W20_182
• Status: Recruiting
• Start date: November 24, 2020
• Est. completion date: November 2025

Study information

• Verified date: December 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.

Description:

Familial adenomatous polyposis (FAP) is characterized by formation of up to hundreds to thousands of polyps throughout the entire colon and rectum. When left untreated, nearly all patients with FAP develop colorectal cancer at a median age of 35-45 years. To prevent colorectal cancer in patients with FAP, prophylactic colorectal surgery is performed. The preferred surgical procedures for FAP are a restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) or a subtotal colectomy with ileorectal anastomosis (IRA) or ileosigmoidal anastomosis (ISA).

After both types of prophylactic colorectal surgery, subtotal colectomy with IRA/ISA or proctocolectomy with IPAA, patients will require life-long surveillance because disease progression and development of new adenomas in retained rectum, pouch or residual rectal cuff will occur.

The 10-years risk of developing one or more adenomas in the rectum after IRA is 100% compared to 33% in the pouch after IPAA. The risk of developing rectal cancer after IRA was found to be 9% and 11% in two large studies with a median follow-up of 12.8 and 15 years, respectively. One study showed that the 10-years risk of developing a carcinoma in the pouch was 1%. As patients are usually operated at a young age, and nowadays have a long life-expectancy, the actual cumulative life-time risk will presumably be higher.

The recently published ESGE (European Society of Gastrointestinal Endoscopy) polyposis guideline recommends a one to two yearly endoscopic surveillance interval after prophylactic colorectal surgery in FAP, both for patients that underwent IRA/ISA and IPAA, with removal of all polyps >5mm. This recommendation is based on expert-opinion, since no studies have been reported comparing the efficacy and safety of different surveillance intervals. No advices are provided on which patients will benefit from which surveillance interval.

With the proposed study, the investigators aim to provide evidence for personalized endoscopic surveillance for patients with FAP that have undergone (procto)colectomy with construction of an IRA/ISA or IPAA with the goal to prevent development of advanced neoplasia (AN) by endoscopically removing lesions before they progress to AN.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germline mutation) and/or clinical diagnosis (>100 colorectal adenomas in combination with a positive family history of FAP)

• Have undergone prophylactic (procto)colectomy with IRA/ISA or IPAA

• Age 18 years or older

Exclusion Criteria:

• Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies

• Cancer at baseline endoscopy

• Need for surgery

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Colorectal Neoplasms
• Familial Adenomatous Polyposis
• Nasopharyngeal Neoplasms

Intervention

Procedure:
• Personalized surveillance and intervention protocol
This study uses one arm. Participants will undergo endoscopic surveillance with intervals between 6 months and 2 years, depending on severity of polyposis and performed endoscopic interventions.

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre	Amsterdam	Noord-Holland

Sponsors (10)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Hôpital Edouard Herriot, Hospital Clinic of Barcelona, Hospital General Universitario de Alicante, Leiden University Medical Center, Maria Sklodowska-Curie Institute - Oncology Center, St Mark's Hospital Foundation, St. Orsola Hospital, The Netherlands Cancer Institute, University Medical Center Mainz

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Advanced neoplasia	Incidence of advanced neoplasia (advanced adenoma and cancer). An advanced adenoma is defined as size = 10mm and/or high-grade dysplasia. This surveillance and intervention protocol will be considered successful when the incidence of advanced neoplasia is less than 5% after a study period of 5 years.	Up to 5 years
Secondary	Characteristics polyps	Incidence and characteristics of polyps detected/removed in patients with IRA/ISA and IPAA	Up to 5 years
Secondary	Radicality of different endoscopic intervention techniques	Rate of radical endoscopic interventions	Up to 5 years
Secondary	Feasibility endoscopic interventions	Incidence of lesions not amenable to endoscopic removal	Up to 5 years
Secondary	Surgical interventions	Incidence of surgical interventions	Up to 5 years
Secondary	Surveillance burden	Surveillance burden (number of endoscopies per patient)	Up to 5 years
Secondary	Complications	Incidence of endoscopy related complications	Up to 5 years