Laparoscopic uncut Roux-en-Y for radical distal gastrectomy: the study protocol for a multirandomized controlled trial

Abstract

Gastric cancer is the third most common cause of cancer-related deaths and is the fifth highest incidence of cancer worldwide, especially in Eastern Asia, Central and Eastern Europe, and South America. Currently, surgery is the only curative treatment for gastric cancer; however, digestive tract reconstruction after distal gastrectomy for gastric cancer is controversial due to the postoperative complications such as reflux gastritis. There is an increasing trend toward laparoscopic uncut Roux-en-Y (URY) for radical gastrectomy. However, evidence on the feasibility of this procedure in patients undergoing laparoscopic radical distal gastrectomy is still absent. Thus, a prospective randomized trial is warranted. This is a prospective, multicenter, two-arm randomized controlled trial in which 210 patients will be randomly assigned to two groups: laparoscopic URY (n=105) and laparoscopic Billroth II plus Braun anastomosis (n=105). Each participant must be pathologically diagnosed with gastric cancer and undergo laparoscopic radical gastrectomy at Xijing Hospital and other four hospitals. The laparoscopic URY procedure is based on the Billroth II gastrojejunostomy plus Braun anastomosis, and then blocked the jejunum input loop at the stump-jejunal anastomosis. The patients' demographic and pathological characteristics will be recorded. The total and oral nutritional intake, general data, total serum protein, serum albumin, blood glucose, and temperature will be recorded before surgery and at the time of hospitalization. Postoperative adverse events will also be recorded, as well as at follow-up appointments at three months and six months after surgery. The rate of reflux gastritis will represent the primary endpoint, and other secondary endpoints, which are all recorded.

Keywords: Billroth II gastrojejunostomy; Braun anastomosis; anastomosis; jejunum input loop; reflux gastritis.

Figure 1

The trial flow chart. Abbreviations: BB, Billroth II plus Braun anastomosis; POD, postoperative day; URY, uncut Roux-en-Y.

Figure 2

Uncut Roux-en-Y gastrojejunostomy after distal gastrectomy. Notes: G means gastrojejunostomy site; B means Braun anastomosis site; T means Treitz ligament. Distance between T and G is 25 cm; distance between T and B₁ is 10 cm and between B₁ and B₂ is more than 1.5 cm; distance between U and G is 5 cm; ditance between G and B (B₁ and B₂) is 25 cm.