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Colorectal Adenoma Canceration in FAP

NCT ID: NCT04531930

Last Updated: 2020-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2030-09-30

Brief Summary

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The current internationally accepted treatment method for familial adenomatous polyposis is prophylactic total colorectal resection combined with endoscopic follow-up. However, total colorectal resection will bring a sharp decline in the quality of life of patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery.

Detailed Description

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Familial adenomatous polyposis is a kind of colorectal cancer syndrome, which belongs to rare diseases. It is estimated that the number of patients in China is about 100,000, accounting for about 1% of all colorectal cancer patients. This type of patients onset between the ages of ten and thirty years old. The typical manifestation is the growth of tens to thousands of colorectal adenomas, and the lifetime risk of colorectal cancer is close to 100%, accompanied by multiple extraintestinal manifestations . Without treatment, the average life span is 40-50 years. The current internationally accepted treatment method is prophylactic total colorectal resection combined with endoscopic follow-up. This program has a significant effect and can extend life expectancy by 10-20 years. However, total colorectal resection will bring a sharp decline in the quality of life of patients. The patients will lose many abilities (working ability, social ability, fertility, etc.) from the age of 20, and the prolonged survival period also brings more misery. This, in turn, also reduces the compliance of treatment. Many patients refuse to accept surgery and turn to endoscopic treatment or even give up treatment. However, there is currently no evidence that methods other than prophylactic surgery can effectively control the risk of colorectal cancer in such patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. Among them, the intensive colonoscopy treatment group will be treated with colonoscopy intensive treatment (that is, colonoscopy treatment is performed every 3 months, Carry out colorectal tumor reduction in segments, and continue to control the growth of adenomas several times) for patients who refuse surgery. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery, so as to explore ways to improve the quality of life of such patients.

Conditions

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Familial Adenomatous Polyposis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery Group

Colorectal surgery

surgery

Intervention Type PROCEDURE

Colorectal surgery, mainly total proctocolectomy.

Enhanced Colonoscopy Group

Enhanced colonoscopic treatment and surveillance

enhanced colonoscopy

Intervention Type PROCEDURE

Colonoscopic treatment and surveillance in every 3 months.

Self Choice Group

The patients choose the interventional methods, even do nothing.

self choosed methods

Intervention Type OTHER

A patient chooses a method for himself other than surgery.

Interventions

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surgery

Colorectal surgery, mainly total proctocolectomy.

Intervention Type PROCEDURE

enhanced colonoscopy

Colonoscopic treatment and surveillance in every 3 months.

Intervention Type PROCEDURE

self choosed methods

A patient chooses a method for himself other than surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The initial number of polyps is between 100-1000 visually;
* Pathological diagnosis of multiple lesions confirmed colorectal adenoma;
* Germline mutation detection is clearly a point mutation or large deletion of APC gene;
* No cancer or distant metastasis.

Exclusion Criteria

* Age \<18, or \>40 years old;
* The initial number of polyps is \<100, or \>1000;
* The polyp has become cancerous or has suspected distant metastasis;
* Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients who need emergency surgical resection;
* Past history of colorectal surgery;
* Suffering from malignant tumors in other parts and requiring treatment or using chemotherapy drugs or NSAIDs;
* The patient has contraindications to colonoscopy;
* Patients or family members cannot understand the conditions and goals of this study;
* The patient plans to receive surgical treatment of preventive colorectal resection;
* Other reasons considered by the study doctor to be inappropriate for inclusion in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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En-Da Yu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun-Jie XING, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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En-Da YU, MBBS

Role: CONTACT

Phone: 8613901688626

Email: [email protected]

References

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Karstensen JG, Burisch J, Pommergaard HC, Aalling L, Hojen H, Jespersen N, Schmidt PN, Bulow S. Colorectal Cancer in Individuals With Familial Adenomatous Polyposis, Based on Analysis of the Danish Polyposis Registry. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2294-2300.e1. doi: 10.1016/j.cgh.2019.02.008. Epub 2019 Feb 8.

Reference Type BACKGROUND
PMID: 30743005 (View on PubMed)

Bulow S. Results of national registration of familial adenomatous polyposis. Gut. 2003 May;52(5):742-6. doi: 10.1136/gut.52.5.742.

Reference Type BACKGROUND
PMID: 12692062 (View on PubMed)

Other Identifiers

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SINOFAP2020A

Identifier Type: -

Identifier Source: org_study_id