POLYP Study (gallbladder polyps)

Background

An estmiated 10% of the population has a gallbladder polyp. Most of these polyps are benign. However, about 10% of polyps consist of a (pre) malignant lesion, rising the risk for the development of a gallbladder carcinoma. In order to prevent the malignant degeneration of these polyps, cholecystectomy is advised in these patients.

Based on pre-operative diagnostics it is currently not possible to differentiate between benign and (pre) malignant polyps. Cholecystectomy is recommended for all polyps with a diameter of ≥ 10mm. However, post-operative histopathological analysis demonstrates that 70% of resected polyps are benign lesions. On the other hand, about 30% of all malignant polyps are smaller than the surgical threshold of 10mm. Consequently, this practise leads to substantial over-and under-treatment.

The cost of a cholecystectomy is around 4,000 euros in the Netherlands. Better Pre-operative selection would generate an estimated cost savings of more than 1 million euro on an annual basis. The POLYP study, a nationwide prospective registration study, aims to improve pre-operative distinction of gallbladder polyps and increase expediency of care.

Aim

The POLYP Study is a prospective registration study to determine the optimal treatment for patients with gallbladder polyps. The POLYP study aims to improve pre-operative diagnostics and surveillance, resulting in less surgical over-and under-treatment in patients with gallbladder polyps.

Inclusion

All patients with a suspicion of a gallbladder polyp are eligible to participate in the POLYP study. Additionally, patients in which a gallbladder polyp is found incidentally after cholecystectomy for another indication are eligible for registration.

Methods

The POLYP Study is a prospective registration study. Decisions regarding treatment and follow-up will remain at the discretion of the treating physician in the local hospital. Patients who participate in this study will therefore be treated acoording to the current guidelines. Participation in the study does not require any additional effort from the treating physician. In all participating centers the local coordinator will enlist potential participants with the coordinating investigator. The coordinating investigator will contact the patient or treating physician in order to provide the study information and to obtain informed consent.

The POLYP study will record the following data; Findings during follow-up appointments, results of imaging studies, surgical procedures and any complications, pathology reports, follow-up duration and survival.

Additionally, data on symptomatology and quality of life will be collected through (voluntary) questionnaires. Participation in the questionnaires is voluntary and not required in order to participate in the study. All data will be collected periodically by the coordinating investigator and will be entered into a secure, online database.

Do you have any questions or would you like to get involved? Send an e-mail to the coordinating investigator via info@galblaasafwijking.nl

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