Health TrialsbyHealthPanel

Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

ConditionsGastric CancerDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-69
SponsorKorea University Anam Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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).

  • Conventional Roux-en-Y reconstruction after subtotal gastrectomy

    Procedure/Surgery

    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).

  • Billroth II reconstruction after subtotal gastrectomy

    Procedure/Surgery

    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)

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Long limb Roux-en-Y reconstructionActive comparator 1 intervention
Group B: Conventional Roux-en-Y reconstructionActive comparator 1 intervention
Group C: Billroth II reconstructionActive comparator 1 intervention

Trial outcomes

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

Time frame
12 months

Secondary outcomes

1

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

The number of days from randomization to the visit date when HgA1c is first observed to be \< 6.5% (or 6.0%) post-randomization

Time frame
Every visit date, assessed up to 12, 24, and 36 months
2

Success rate of biochemical resolution of diabetes

Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c ≤ 6% (with or without diabetes medication)

Time frame
12 months, 24 months, 36 months
3

Success rate of biochemical improvement of diabetes

Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c \<6.5% (with or without diabetes medication)

Time frame
12 months, 24 months, 36 months
4

Change in glycated hemoglobin from baseline

percent change

Time frame
12 months, 24 months, 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Korea University Anam Hospital

Lead sponsor

Korea University Ansan Hospital

Collaborator

Korea University Guro Hospital

Collaborator

Chonnam National University Hospital

Collaborator

Kyung Hee University Hospital at Gangdong

Collaborator

Ajou University

Collaborator

Source ClinicalTrials.gov
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