A Study Comparing Billroth II With Roux-en-Y Reconstruction for Gastric Cancer
Condition: Gastric Cancer; Stomach Cancer; Gastrectomy
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Both Billroth II and Roux en Y are acceptable techniques of reconstruction after subtotal
      gastrectomy, however the debate one which is better remains unanswered. The aim of this study
      is to compare Billroth II and Roux en Y reconstruction techniques after radical distal
      subtotal gastrectomy for gastric cancer in terms of postoperative outcomes and quality of
      life. The investigators hypothesize that Roux en Y will have lesser gastrointestinal symptoms
      and reflux problems when compared to Billroth II reconstruction. Patients with resectable
      gastric cancer meeting the inclusion criteria will be consented and enrolled. Data on
      demographics, nutrition, gastrointestinal symptoms, and quality of life will be collected.
      They will be randomized after completion of distal subtotal gastrectomy to under go either
      Roux en Y or Billroth II reconstruction. Surgery data will be collected post-operatively.

      At 6 months follow up a repeat nutritional assessment using clinical and biochemical
      parameters will be carried out. The biochemical markers are part of routine follow up. The
      final assessment will be at the one year post surgery visit when by interview using EORTC 30
      questionnaire quality of life data, gastrointestinal symptoms and nutritional assessment and
      surgery data for recurrence will be repeated. At one year patients will also have upper
      gastrointestinal endoscopy, which is part of routine follow up. At endoscopy stump gastritis
      will be graded and esophageal reflux assessed as per Los Angeles classification. It is
      postulated that 5% of the patients on Roux en Y reconstruction will experience poor clinical
      symptoms compared to 25% of those on Billroth II based on reflux symptoms. To achieve a
      statistical significance with 95% power and a 2-sided test of 5% for this 20% clinical
      difference, 80 subjects for each arm will be required. Factoring a 10% attrition rate for
      mortality and lost to follow up, a total of 160 subjects to be randomized equally will be
      recruited.
    

Detailed description: 
      Subtotal distal gastrectomy with lymphadenectomy offers the best chance of cure either alone
      or in conjunction with other modalities for patients with operable distal gastric cancer.
      After a subtotal gastrectomy the gastrointestinal continuity can be restored by various
      techniques. Billroth I, Billroth II and Roux-en-Y reconstruction are all acceptable procedure
      with each having its merits and demerits. The choice of reconstructive procedure varies
      depending on individual Surgeons preference and institutional practice. There is geographical
      difference in practice with majority of surgeons in the east favoring Billroth I, while in
      the west; Roux-en-Y is more commonly employed (1). Billroth I vs Roux-en-Y reconstruction has
      been extensively studied with a prospective series by Sounya Nunobe et al that reported
      superior symptomatic and functional outcomes of Roux-en-Y procedure (2). However a randomised
      trial by Makoto Ishikawa et al found limited advantages of Roux-en-Y over Billroth I
      reconstruction (3). In this study Roux-en-Y had fewer problems related to reflux of bile but
      a higher incidence of stasis in the Roux limb resulting in longer hospital stay. Another
      reason that some surgeon avoids doing Roux-en-Y is a triad of post operative symptoms
      including abdominal pain, vomiting and nausea called Roux-en-Y loop syndrome (4,5). Billroth
      II reconstruction in comparison to Roux-en-Y is a simpler operation with only one anastomosis
      and faster operating time (6). This has implications while managing gastric cancer patients
      who may be malnourished and a simpler procedure may have lesser risk of complications and
      yield better outcomes. Billroth II has been criticized for increased reflux associated
      problem like esophagitis and gastritis, also noteworthy are risk of afferent loop and dumping
      syndrome. Long term nutritional outcomes are similar for both procedures (7).
    

Intervention name(s): Roux-en-Y or Billroth II
Intervention type(s): Procedure
Intervention description(s): Roux-en-Y had fewer problems related to reflux of bile but a higher incidence of stasis in the Roux limb resulting in longer hospital stay. Some surgeon avoids doing Roux-en-Y is a triad of post operative symptoms including abdominal pain, vomiting and nausea called Roux-en-Y loop syndrome. Billroth II reconstruction is a simpler operation with only one anastomosis and faster operating time. This has implications while managing gastric cancer patients who may be malnourished and a simpler procedure may have lesser risk of complications and yield better outcomes. Billroth II has increased reflux associated problem like esophagitis and gastritis, risk of afferent loop and dumping syndrome. Long term nutritional outcomes are similar for both procedures.
Other intervention name(s): Reconstruction
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastric Cancer; Gastrectomy; Billroth 2; Roux-en-Y