The CHOLEGAS study: multicentric randomized, blinded, controlled trial of gastrectomy plus prophylactic cholecystectomy versus gastrectomy only, in adults submitted to gastric cancer surgery with curative intent.
BACKGROUND
The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery. At the present, no randomized study has been published and the decision of gallbladder management is left to each surgeon preference.


METHODS
The study is a randomized controlled investigation. The study will be performed in the General and Oncologic Surgery, Department of Oncology-Azienda Ospedaliero-Universitaria Careggi-Florence-Italy, a large teaching institution, with the participation of all surgeons who accept to be involved in, together with other Italian Surgical Centers, on behalf of the GIRCG (Italian Research Group for Gastric Cancer).The patients will be randomized into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group he/she will be submitted to standard gastric surgery only.


BACKGROUND
ClinicalTrials.gov ID. NCT00757640.
Farsi
Marco
M
General and Oncologic Surgery, Careggi Hospital, Florence, Italy. marco.farsi@tin.it
Bernini
Marco
M
Bencini
Lapo
L
Miranda
Egidio
E
Manetti
Roberto
R
de Manzoni
Giovanni
G
Verlato
Giuseppe
G
Marrelli
Daniele
D
Pedrazzani
Corrado
C
Roviello
Francesco
F
Marchet
Alberto
A
Cristadoro
Luigi
L
Gerard
Leonardo
L
Moretti
Renato
R
D000328:Adult; D002763:Cholecystectomy / Q000009:adverse effects; D002769:Cholelithiasis / Q000209:etiology / Q000517:prevention & control*; D005743:Gastrectomy / Q000009:adverse effects*; D006801:Humans; D007558:Italy; D008197:Lymph Node Excision; D013274:Stomach Neoplasms / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome