Gastrectomy With or Without Drainage (ADiGe)?

Integrated University Hospital Trust of Verona

Status: Completed

Conditions: Gastric Cancer

Treatments: Device: Avoid drain placement; Device: Drain placement

Study type: Interventional

Funder types: Other

Identifiers

NCT04227951

2245CESC

Details and patient eligibility

About

Prophylactic use of anastomotic drain in upper gastrointestinal surgery has been questioned in the last 15 years but only small studies have been conducted. In 2015 a Cochrane meta analysis on four Randomized Controlled Trials (RCT) concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless the Authors evidenced the moderate/low methodological quality of the included studies and highlighted how 3 out of four came from Eastern countries. Despite the above mentioned limits, Enhanced Recovery After Surgery (ERAS) society published the guidelines for gastrectomy that strongly recommend, with high evidence level, to avoid routine use of drain in gastric surgery. After 2015 some other retrospective studies have been published, all with inconsistent results. Our objective is to perform a multicentre prospective trial in a large western cohort of patients to establish wether avoid routine use of anastomotic drain does not led to an increasing of postoperative invasive procedure.

Enrollment: 404 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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404 participants in 2 patient groups

Drain

Sham Comparator group

Description:

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.

Treatment:

Device: Drain placement

No Drain

Experimental group

Description:

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.

Treatment:

Device: Avoid drain placement