Roux-en-Y Versus Billroth II Reconstruction After Subtotal Gastrectomy in Gastric Cancer Comorbid With Type II Diabetes

NCT ID: NCT01528059

Last Updated: 2012-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-03-31

Brief Summary

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Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be varied by different gastric-small intestine reconstruction used in the procedure. There are reports that Roux en Y reconstruction may give a better result. The purpose of this study is to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid with type 2 diabetes.

Detailed Description

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Type 2 diabetes may cause severe complications such as nephropathy and retinopathy. Additionally, it is associated with increased risk for cardiovascular events and diseases. Surgical intervention with gastric bypass has been shown to attenuate glycemic levels in obese patient comorbid with type 2 diabetes. However, since gastric bypass is not a standard procedure, surgical protocol including stomach and small intestine reconstruction may be varied. The investigators and others have found that stomach and small intestine reconstruction may affect the efficacy of diabetic treatment. In this study, the investigators will compare the efficacy of Billroth II and Roux en Y reconstruction on glycemic control in stomach cancer patients with type 2 diabetes. Both Billroth II and Roux en Y are used in stomach-small intestine reconstruction after subtotal gastrectomy. No differences in postoperative outcomes and quality of life have been reported in Billroth II and Roux en Y reconstruction.

Conditions

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Gastric Cancer Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Billroth II

After stomach resection, the remnant stomach is connected to the jejunum.

Group Type ACTIVE_COMPARATOR

Stomach-small intestine reconstruction

Intervention Type PROCEDURE

Billroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes

Roux en Y

After stomach resection, the remnant stomach is connected to the distal jejunum while duodenum and the proximal jejunum is reconnected to jejunum.

Group Type ACTIVE_COMPARATOR

Stomach-small intestine reconstruction

Intervention Type PROCEDURE

Billroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes

Interventions

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Stomach-small intestine reconstruction

Billroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with Type 2 diabetes
2. Diagnosed with gastric cancer

Exclusion Criteria

1. Type 1 diabetes
2. Unresectable cancers
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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feng Zheng

OTHER

Sponsor Role lead

Responsible Party

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feng Zheng

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yu Wang, M.D

Role: PRINCIPAL_INVESTIGATOR

Dongfang Hospital, Xiamen University

Locations

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DongFang Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu Wang, M.D

Role: CONTACT

13805019453

Zhongdong Zhou, M.D

Role: CONTACT

13705038043

Facility Contacts

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Yu Wang, M.D

Role: primary

13805019453

ZhongDong Zhou, M.D

Role: backup

13705038043

Other Identifiers

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FNSP2009Y0039

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DongFang

Identifier Type: -

Identifier Source: org_study_id

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