Colorectal Adenoma Canceration in FAP

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorChanghai Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

The anticipants will be allocated in one of the three groups, and accept the corresponding intervention and at least 3 year follow up.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • surgery

    Procedure/Surgery

    Colorectal surgery, mainly total proctocolectomy.

  • enhanced colonoscopy

    Procedure/Surgery

    Colonoscopic treatment and surveillance in every 3 months.

  • self choosed methods

    Other intervention

    A patient chooses a method for himself other than surgery.

Treatment groups

124 Participants
are divided into 3 treatment groups
Group A: Surgery Group1 intervention
Group B: Enhanced Colonoscopy Group1 intervention
Group C: Self Choice Group1 intervention

Trial outcomes

Primary outcomes

1

3yCR

3 year Cancerous rate

Time frame
3 years

Secondary outcomes

1

Adenoma number Change

Change of adenoma number by 3 years

Time frame
3 years
2

3yOSR

3 year overall survival rate

Time frame
3 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: