Does the Technique of Duodenal Resection Affect the Incidence of Duodenal Stump Fistula After Gastrectomy for Gastric Cancer ? A Randomized Controlled Trial (DRTST: Duodenal Resection Tri-staple Technology)

BACKGROUND Gastric cancer is still one of the most frequent malignancies in Europe. In United States the estimated new cases in 2010 were 21000 (12730 male and 8270 female) with 10570 estimated deaths (6350 male and 4220 female)[7,8]. In Italy the estimated new cases in 2013 were 13200 (7900 males and 5300 female) (AIOM-AIRTUM, I numeri del cancro in Italia - 2013, www.registri-tumori.it) .The incidence rates in 2005-2009 were 21.6 and 10.8 per 100,000 in males and females respectively. The mortality rates in 2005-2009 were 14.9 and 7.3 per 100,000 in males and females respectively. (www.itacan.ispo.toscana.it).A total or subtotal gastrectomy with D2 lymph node dissection and R0 margins remains the standard of care for gastric cancer[9,10]. Despite this, in low-volume centers gastrectomy still remains a challenging procedure with a notable morbidity rate (33%-43%) and mortality rate (7%-12%)[11,12]. Duodenal stump fistula (DSF) represents an infrequent but severe complication after total or subtotal gastrectomy for gastric cancer, with incidence of 2,5 - 5% and mortality rate ranging from 7% to 67%(1-5). Several factors were identified as possible cause of DSF, such as local hematoma, inflammation, intra-operative inadequate closure of the duodenal stump, incorrect drain position, devascularization, post-operative distension of the duodenum and R1-R2 resections[2,13].

There are many DSF-related complications leading to longer hospitalization times, such as intra-abdominal abscesses, wound infections, diffuse peritonitis, sepsis, malnutrition, pancreatitis, abdominal bleeding, and pneumonia. (3) DSF is often difficult to treat because of the highly enzyme-rich duodenal juice and deep location of the fistula. In a retrospective multicenter study (2) 3,685 patients undergoing gastrectomy for malignancies who developed 68 DSFs were analyzed; it was reported that DSF features had changed in the last 30 years and that DSF alone no longer leads to death; some complications observed in the past, such as fluid and electrolyte loss and dermatitis, have disappeared owing to improvements( in particular parenteral nutrition and wound care). However, additional new complications such as bleeding and fistulas of neighboring organs were emerging. Although medical therapy is associated with better outcomes, surgery is still mandatory in cases of severe abdominal sepsis or bleeding not otherwise manageable.

However, reoperation is often ineffective owing to postoperative edema and inflammation, and the prognosis of patients undergoing surgery for DSF remains very poor. To improve the outcome of these patients, many surgical procedures have been proposed from washing the peritoneal cavity and abdominal drainage to tube duodenostomy (14,15), closure of the fistula, fistula repair with a rectus abdominis flap (16), fistula closure by Roux-en-Y duodenojejunostomy(17,18), biliogastric diversion, laparostomy, and pancreatoduodenectomy (19) but surgeons are often unsure about the best management and the result are often unsuccessful.

In a recent Korean national RCT (6) on open (ODG) vs laparoscopic distal gastrectomy (LADG), the incidence of duodenal stump leakage after laparoscopyc gastrectomy was about 1%; in this population study the use of tri-staple technology for duodenal resection was mandatory. In our clinical practice, the incidence of DSF after open gastrectomy is about 3-5% adopting different techniques of duodenal stump resection/closure.

The aim of this study is to evaluate if duodenal stump resection/closure using tri-staple technology can significantly decrease the incidence of DSF after open gastrectomy as compared to the other conventional methods adopted in the clinical practice (1% vs 5%).