Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

NCT04284943 | Unknown DMC

• 1 other identifier: STARDOM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multi-center, randomized controlled trial to compare Billroth II reconstruction versus conventional Roux-en-Y reconstruction versus long limb Roux-en-Y reconstruction for glycemic control in patients with concurrent type 2 diabetes and gastric cancer.

Conditions

Gastric Cancer; Diabetes Mellitus, Type 2

Keywords

Gastric Cancer; Diabetes Mellitus, Type 2; Subtotal Gastrectomy

Outcome Measures

Primary Outcomes (1)

• The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5%

  The proportion of subjects with HbA1c \< 6.5% without diabetes medications

  12 months

Secondary Outcomes (19)

• Time to first occurence of glycated hemoglobin < 6.5% (or 6.0%)

  Every visit date, assessed up to 12, 24, and 36 months

• Success rate of biochemical resolution of diabetes

  12 months, 24 months, 36 months

• Success rate of biochemical improvement of diabetes

  12 months, 24 months, 36 months

• Change in glycated hemoglobin from baseline

  12 months, 24 months, 36 months

• Change in fasting plasma glucose level from baseline

  12 months, 24 months, 36 months

Study Arms (3)

Long limb Roux-en-Y reconstruction

ACTIVE COMPARATOR

Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.

Procedure: Long limb Roux-en-Y reconstruction after subtotal gastrectomy

Conventional Roux-en-Y reconstruction

ACTIVE COMPARATOR

Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.

Procedure: Conventional Roux-en-Y reconstruction after subtotal gastrectomy

Billroth II reconstruction

ACTIVE COMPARATOR

Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer

Procedure: Billroth II reconstruction after subtotal gastrectomy

Interventions

Long limb Roux-en-Y reconstruction after subtotal gastrectomy PROCEDURE

The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).

Long limb Roux-en-Y reconstruction

Conventional Roux-en-Y reconstruction after subtotal gastrectomy PROCEDURE

The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).

Conventional Roux-en-Y reconstruction

Billroth II reconstruction after subtotal gastrectomy PROCEDURE

The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop)

Billroth II reconstruction

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Distal gastric adenocarcinoma diagnosed pathologically under preoperative endoscopic biopsy, and clinical stage I-II
• Body mass index ≥ 23 kg/m2
• Type 2 diabetes and HbA1c ≥ 6.5%

You may not qualify if:

• Insulin usage for glycemic control at the time of screening evaluation
• Prior gastrointestinal surgery including splenectomy, hepatobiliary and pancreatic surgery (except hemorrhoidectomy, herniorrhaphy, and appendectomy)
• Abdominal, thoracic, pelvic and/or obstetric-gynecologic surgery within 3 months
• Cardiovascular conditions including significant known CAD, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension. Subjects with CAD that have been successfully treated with CABG or PCI, and have no evidence of active ischemia are eligible
• Kidney disease including renovascular hypertension, renal artery stenosis, or end-stage renal disease
• Chronic liver disease including liver cirrhosis, alpha-1 antitrypsin deficiency
• Gastrointestinal disorders including inflammatory bowel disease (Crohn's disease or ulcerative colitis) or any malabsorptive disorders
• Psychiatric disorders including dementia, active psychosis, history of suicide attempts, alcohol or drug abuse within 12 months
• Severe pulmonary disease defined as FEV1 \<50% of predicted value
• Anemia defined as hemoglobin less than 8 in females and 10 in males
• Malignancy within 5 years (except squamous cell and basal cell cancer of the skin). Subjects diagnosed with early or stage I cancer than have been successfully treated are eligible per investigator discretion
• Frail elderly (Rockwood Clinical Frailty Scale ≥5)
• Any condition or major illness that, in the investigator's judgement, places the subject at undue risk by participating in the study
• Unable to understand the risks, realistic benefits and compliance requirements of each program
• Use of investigational therapy or participation in any other clinical trial within 3 months

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Guangdong Provincial People's Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Korea University Ansan Hospital: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sungsoo Park, MD, PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sungsoo Park, MD, PhD

CONTACT

+82 2 920 6772; kugspss@korea.ac.kr

Yeongkeun Kwon, MD, PhD

CONTACT

+82 2 920 6772; kukwon@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 26, 2020
• Study Start: December 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)