NCT01257711

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

10.8 years

First QC Date

June 8, 2010

Last Update Submit

March 5, 2021

Conditions

Gastric CancerStomach CancerGastrectomy

Keywords

Gastric CancerGastrectomyBillroth 2Roux-en-Y

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    1 year

Secondary Outcomes (4)

  • Quality of life pre and post operatively will be compared between Billroth II and Roux En Y reconstruction after radical distal subtotal gastrectomy.

    1 year

  • Gastrointestinal symptoms assessment

    1 year

  • Assessing nutritional status

    1 year

  • Grading of gastritis and/or esophagitis on endoscopy

    1 year

Study Arms (2)

Billroth II reconstruction

OTHER

Following Radical Distal Subtotal Gastrectomy, patient will be randomised to restore the continuity of the intestine with the stomach using Billroth II reconstruction.

Procedure: Roux-en-Y or Billroth II

Roux-en-Y reconstruction

OTHER

Following Radical Distal Subtotal Gastrectomy, patient will be randomised to restore the continuity of the intestine with the stomach using Roux-en-Y reconstruction.

Procedure: Roux-en-Y or Billroth II

Interventions

Roux-en-Y or Billroth IIPROCEDURE

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.

Also known as: Reconstruction
Billroth II reconstructionRoux-en-Y reconstruction

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Chinese University of Hong Kong

Hong Kong, Shatin, NT, Hong Kong

Location

National University Hospital

Kent Ridge, 119074, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (7)

  • Woodward A, Sillin LF, Wojtowycz AR, Bortoff A. Gastric stasis of solids after Roux gastrectomy: is the jejunal transection important? J Surg Res. 1993 Sep;55(3):317-22. doi: 10.1006/jsre.1993.1148.

    PMID: 8412117BACKGROUND

  • Mathias JR, Fernandez A, Sninsky CA, Clench MH, Davis RH. Nausea, vomiting, and abdominal pain after Roux-en-Y anastomosis: motility of the jejunal limb. Gastroenterology. 1985 Jan;88(1 Pt 1):101-7. doi: 10.1016/s0016-5085(85)80140-2.

    PMID: 3964759BACKGROUND

  • Yoshino K. [History of gastric cancer surgery]. Nihon Geka Gakkai Zasshi. 2000 Dec;101(12):855-60. Japanese.

    PMID: 11201113BACKGROUND

  • Fukuhara K, Osugi H, Takada N, Takemura M, Higashino M, Kinoshita H. Reconstructive procedure after distal gastrectomy for gastric cancer that best prevents duodenogastroesophageal reflux. World J Surg. 2002 Dec;26(12):1452-7. doi: 10.1007/s00268-002-6363-z. Epub 2002 Oct 10.

    PMID: 12370787BACKGROUND

  • Osugi H, Fukuhara K, Takada N, Takemura M, Kinoshita H. Reconstructive procedure after distal gastrectomy to prevent remnant gastritis. Hepatogastroenterology. 2004 Jul-Aug;51(58):1215-8.

    PMID: 15239282RESULT

  • Nunobe S, Okaro A, Sasako M, Saka M, Fukagawa T, Katai H, Sano T. Billroth 1 versus Roux-en-Y reconstructions: a quality-of-life survey at 5 years. Int J Clin Oncol. 2007 Dec;12(6):433-9. doi: 10.1007/s10147-007-0706-6. Epub 2007 Dec 21.

    PMID: 18071862RESULT

  • Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.

    PMID: 16240061RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Anastomosis, Roux-en-YGastroenterostomyPlastic Surgery Procedures

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Asim Shabbir, MBBS

    National University Hospital System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 8, 2010

First Posted

December 10, 2010

Study Start

October 9, 2008

Primary Completion

July 31, 2019

Study Completion

February 12, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations

SG(3)HK(1)