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

NCT ID: NCT01257711

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-09
• Study Completion Date: 2020-02-12

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.

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).

Conditions

Gastric Cancer; Stomach Cancer; Gastrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Billroth II reconstruction

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

Group Type: OTHER

Roux-en-Y or Billroth II

Intervention Type: PROCEDURE

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.

Roux-en-Y reconstruction

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

Group Type: OTHER

Roux-en-Y or Billroth II

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Reconstruction

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tan Tock Seng Hospital

OTHER

Sponsor Role: collaborator

Changi General Hospital

OTHER

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

National Healthcare Group, Singapore

OTHER_GOV

Sponsor Role: lead

Responsible Party

Asim Shabbir

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asim Shabbir, MBBS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital System

Locations

The Chinese University of Hong Kong

Hong Kong, Shatin, NT, Hong Kong

National University Hospital

Kent Ridge, , Singapore

Tan Tock Seng Hospital

Singapore, , Singapore

Changi General Hospital

Singapore, , Singapore

Countries

Hong Kong; Singapore

References

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.

Reference Type: BACKGROUND

PMID: 8412117 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3964759 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 11201113 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12370787 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15239282 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18071862 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16240061 (View on PubMed)

Other Identifiers

B/08/333

Identifier Type: -

Identifier Source: org_study_id