Gastrectomy With or Without Drainage (ADiGe)? (ADiGe)
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastrectomy, Drain, Drainage
Eligibility Criteria
Inclusion Criteria:
- all consecutive patients that undergo total or subtotal gastrectomy with a curative intent, for histologically proven gastric cancer or esophago-gastric junction cancer Siewert type II or III, in surgical investigator centres from the beginning of the study until reaching the accrual number
- esophageal involvement <= 2 cm
- patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy
- open, hybrid, laparoscopic or robotic approach
- all types of anastomosis (circular stapled, linear stapled, hand sewn)
Exclusion Criteria:
- refuse to sign informed consent
- age <18
- Heart failure New York Heart Association (NYHA) class IV
- severe liver disease (Child >= 7)
- pregnancy
- metastatic disease
- emergency surgery
- palliative surgery
- operation different from total or subtotal oncological gastrectomies (e.g. pylorus preserving, proximal gastrectomy)
- lymphnodal dissection <D1
- reconstruction different from Roux-en-Y or Billroth II
- multiple organ resections (except for cholecystectomy)
- gastric cancer with duodenal involvement
- intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Sites / Locations
- Ospedale Morgagni di Forlì - Chirurgia generale
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga- Chirurgia Generale
- Policlinico San Marco, GSD - Chirurgia Generale ed Oncologica
- Policlinico S.Orsola-Malpighi - Dipartimento di Chirurgia Generale
- ASST Grande Ospedale metropolitano Niguarda - Chirurgia generale oncologica e mini-invasiva
- Ospedale San Raffaele - Chirurgia Gastroenterologica -
- Azienda Ospedaliero Universitaria Modena - Chirurgia Oncologica, Generale e d'Urgenza
- Ospedale Federico II di Napoli- Chirurgia Generale
- Azienda Ospedaliera Universitaria Parma - UO Clinica Chirurgica Generale
- Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Drain
No Drain
Participants enrolled in this arm have an abdominal drain positioned at the end of the operation (any type, inserted from right flank with the tip close to the esophago-jejunal or Gastro-jejunal anastomosis and the duodenal stump). Drain will stay in place until postoperative day (POD) 4th (drain output and quality will be registered). If normal drain debt and patient have no abdominal complications that need reoperation and/or percutaneous drain placement until POD 4, a methylene-blue test is be performed (200 ml water + 5 ml blue orally, check drain after 60 minutes: negative test if no blu was seen in the drain). If negative-blue test drain can be removed according to centre preference (no strict POD defined); if positive-blue test complication will be treated according to centre preference. Only in this arm drain related complications are registered. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.
Participants enrolled in this arm do not have any abdominal drain placed at the end of the operation. Postoperative management (e.g. resume of oral intake, anastomosis integrity tests) is left to centre preference. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.