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A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer

21 Years
80 Years
Open (Enrolling)
Gastric Cancer, Stomach Cancer, Gastrectomy

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Trial Information

A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer

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).

Inclusion Criteria:

- Patient able to give informed consent

- Age 21 - 80 years both male & females

- Patients with histopathologically confirmed adenocarcinoma of the distal lesser
curve, distal greater curve, incisura and antrum that are deemed suitable for
elective radical subtotal gastrectomy with curative intent.

Exclusion Criteria:

- Unable to give informed consent

- Patients who have undergone previous gastrectomy

- Patients with stomach cancer or previous small bowel surgery precluding
construction of either form of anastomosis thus preventing randomization.

- Patients operated for palliation of gastric outlet obstruction, bleeding, perforation
and obstruction

- Emergency gastrectomy for complications related to tumor.

- Patients with early gastric cancer who can have curative treatment by endoscopic

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The aim of this study is to compare Billroth II and Roux En Y reconstruction after radical distal subtotal gastrectomy for gastric cancer in terms of postoperative outcomes.

Outcome Description:

The outcomes include postoperative gastrointestinal symptoms, nutritional status, gastritis and/or esophagitis on endoscopy and quality of life up to one year after surgery. With the results, we can have a scientific basis in choosing the more suitable method of reconstruction for our patients.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Asim Shabbir, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital System


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

October 2008

Completion Date:

December 2016

Related Keywords:

  • Gastric Cancer
  • Stomach Cancer
  • Gastrectomy
  • Gastric Cancer
  • Gastrectomy
  • Billroth 2
  • Roux-en-Y
  • Stomach Neoplasms