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A Study Comparing Billroth II With Roux-en-Y Reconstruction for Gastric Cancer (SCAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by National Healthcare Group, Singapore
Sponsor:
Collaborators:
Tan Tock Seng Hospital
Changi General Hospital
Chinese University of Hong Kong
Information provided by (Responsible Party):
Asim Shabbir, National Healthcare Group, Singapore
ClinicalTrials.gov Identifier:
NCT01257711
First received: June 8, 2010
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Gastric Cancer
Stomach Cancer
Gastrectomy
Procedure: Roux-en-Y or Billroth II

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer

Resource links provided by NLM:


Further study details as provided by National Healthcare Group, Singapore:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of life pre and post operatively will be compared between Billroth II and Roux En Y reconstruction after radical distal subtotal gastrectomy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Symptomatic outcomes of both procedures have significant bearing on quality of life of patients and at the end be able to identify the better among the two procedure.

  • Gastrointestinal symptoms assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Grading of clinical symptom is based on the total score of the the five items epigastric pain, heartburn, vomiting bile, postprandial bloating and nausea)pre and post operatively at 1 year. The higher the grade the poorer the outcome.

  • Assessing nutritional status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Biochemical parameters as well as the height and weight of patients are measured pre operatively, 6 months and 1 year post operatively to compute the BMI. The nutrition assessment are scored by using the NRI and total lymphocyte count.

  • Grading of gastritis and/or esophagitis on endoscopy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Endoscopic classification of inflammation of the remnant stomach to be graded one year after surgery. The gastritis will be reported according to the updated Sydney classification with the morphologic pattern, etiology & topography being reported.


Estimated Enrollment: 160
Study Start Date: October 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Radical Distal Subtotal Gastrectomy
Following the removal of the stomach, patient will be randomised to restore the continuity of the intestine with the stomach using either of the two procedure named Roux-en-Y or Billroth II reconstruction by randomisation
Procedure: Roux-en-Y or Billroth II
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 Name: Reconstruction

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).

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 methods.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257711

Contacts
Contact: Amy YL Tay, Nursing (65)67723192 amy_tay@nuhs.edu.sg
Contact: Asim Shabbir, MBBS (65)67724296 cfsasim@nus.edu.sg

Locations
Hong Kong
The Chinese University of Hong Kong Recruiting
Shatin, NT, Hong Kong SAR, Hong Kong
Principal Investigator: Enders Ng, MBChB         
Singapore
National University Hospital Recruiting
Kent Ridge, Singapore, 119074
Contact: Amy YL Tay, BSc    (65)6772 3192    amy_tay@nuhs.edu.sg   
Contact: Asim Shabbir, MBBS    (65)6772 4296    cfsasim@nus.edu.sg   
Principal Investigator: Asim Shabbir, MBBS         
Sub-Investigator: Jimmy BY So, MBChB         
Changi General Hospital Recruiting
Simei, Singapore, 529889
Principal Investigator: Andrew Wong, MBBS         
Tan Tock Seng Hospital Recruiting
Tan Tock Seng, Singapore, 308433
Principal Investigator: Khong Hee Lim, MBBS         
Sub-Investigator: Rao Jaideepraj, MBBS         
Sponsors and Collaborators
National Healthcare Group, Singapore
Tan Tock Seng Hospital
Changi General Hospital
Chinese University of Hong Kong
Investigators
Principal Investigator: Asim Shabbir, MBBS National University Hospital System
  More Information

Publications:
Responsible Party: Asim Shabbir, Doctor, National Healthcare Group, Singapore
ClinicalTrials.gov Identifier: NCT01257711     History of Changes
Other Study ID Numbers: B/08/333
Study First Received: June 8, 2010
Last Updated: April 13, 2012
Health Authority: Singapore: Domain Specific Review Boards
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by National Healthcare Group, Singapore:
Gastric Cancer
Gastrectomy
Billroth 2
Roux-en-Y

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on November 24, 2014