Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

Gastric cancer patients received subtotal gastrectomy, with Helicobacter pylori eradication

Gastric cancer patients received subtotal gastrectomy, without Helicobacter pylori eradication or Helicobacter pylori negative

Antibiotic eradication therapy (triple or quadriple regimen)

Helicobacter pylori eradication (combination therapy)

In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication.

In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication. In addition, we will analyze the correlation between the incidence and survival rate of this type of stomach cancer by comparing smoking, gastric cancer direct family history, disease stage (TNM staging), the histologic type of stomach cancer (intestinal, diffuse, mixed), and the surgical method (Billoth I, Billoth II) as well as the infection and eradication status of H. pylori.

Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study

Survival period without cancer recurrence or newly developed stomach cancer diagnosis

The number of patients who were diagnosed with new carcinoma on the remnant stomach, over follow-up period of up to 60 months, in eradication group and non-eradication group

Seoul National University Bundang Hospital

Professor

Symptoms and General Pathology

Atrophy

Metaplasia

Gastrointestinal Agents

Amoxicillin

Rabeprazole

Clarithromycin

Omeprazole

Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days

Helicobacter pylori eradication

Omeprazole 20 mg or Rabeprazole 10 mg bid + two placebo (for antibiotics) for 7 days

placebo

Il Ju Choi, M.D., Ph.D.

Helicobacter pylori (H. pylori) is associated with gastric cancer in epidemiological studies.Gastric atrophy and intestinal metaplasia caused by H. pylori are considered as precancerous lesions, but whether H. pylori eradication improves these lesions is controversial.The primary objective of this study is to evaluate whether Helicobacter pylori eradication improves glandular atrophy and intestinal metaplasia which are known to be precancerous condition in patients undergoing subtotal gastrectomy for gastric cancer.

Helicobacter pylori (H. pylori) is a primary etiological agent leading to chronic gastritis and peptic ulcer. The organism is also associated with gastric cancer in epidemiological studies. However, detailed mechanism of carcinogenesis remains unknown. Histolopathological studies indicate that chronic H. pylori infection progresses over decades through stages of chronic gastritis, atrophy, intestinal metaplasia, dysplasia and cancer. Gastric atrophy and intestinal metaplasia are considered as precancerous lesions, but whether H. pylori eradication improves these lesions is controversial. And the issue has not been evaluated in gastric cancer patients. However, despite the lack of evidence proven by a well-designed study, current guidelines from Europe and Japan recommend H. pylori eradication treatment in patients who were treated for gastric cancer by surgically or endoscopically. Thus, it is important to evaluate whether H. pylori eradication can improve known precancerous lesion, i.e. glandular atrophy and intestinal metaplasia in gastric cancer patients. Such histological improvement may eventually reduce secondary gastric cancer development and provide evidence for current guidelines. Helicobacter pylori is a primary etiological agent leading to chronic gastritis and peptic ulcer. The organism is also associated with gastric cancer in epidemiological studies. However, detailed mechanism of carcinogenesis remains unknown. Histolopathological studies indicate that chronic H. pylori infection progresses over decades through stages of chronic gastritis, atrophy, intestinal metaplasia, dysplasia and cancer. Gastric atrophy and intestinal metaplasia are considered as precancerous lesions, but whether H. pylori eradication improves these lesions is controversial. And the issue has not been evaluated in gastric cancer patients. However, despite the lack of evidence proven by a well-designed study, current guidelines from Europe and Japan recommend H. pylori eradication treatment in patients who were treated for gastric cancer by surgically or endoscopically. Thus, it is important to evaluate whether H. pylori eradication can improve known precancerous lesion, i.e. glandular atrophy and intestinal metaplasia in gastric cancer patients. Such histological improvement may eventually reduce secondary gastric cancer development and provide evidence for current guidelines.

Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer

Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Intestinal Metaplasia in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer

National Cancer Center, Korea

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Obesity

Diabetes Mellitus

Diabetes Mellitus, Type 2

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

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

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

Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer

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 after subtotal gastrectomy

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 after subtotal gastrectomy

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 after subtotal gastrectomy

Sungsoo Park, MD, PhD

Yeongkeun Kwon, MD, PhD

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.

Billroth I, Billroth II, or Roux-en-Y procedure follows gastrectomy to reconstruct the gastrointestinal tract. Billroth I procedure restores the normal configuration of the gastrointestinal tract and Billroth II and Roux-en-Y procedure involve the creation of duodenal switch which is thought to be responsible for metabolic effects by altering enteric hormones. Accordingly, several retrospective studies reported that Billroth I reconstruction has less effect on diabetes compared to Billroth II and Roux-en-Y reconstruction. While little is known about different effects of Billroth II and Roux-en-Y procedure, a study retrospectively show that Roux-en-Y procedure has significantly higher rate of T2DM remission than Billroth II procedure. Investigators conduct a randomized controlled trial to control possible confounders arising from diverse metabolic effects of cancer and minimize differences in treatment regimen among patients.

Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

A Randomized Controlled Trial Comparing 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

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

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

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

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

Percent change in total cholesterol at 12 months, 24 months, 36 months

Percent change in triglyceride at 12 months, 24 months, 36 months

Percent change in high-density lipoprotein (HDL) at 12 months, 24 months, 36 months

Percent change in Low-density Lipoprotein (LDL) at 12 months, 24 months, 36 months

number of diabetes medication at 12 months, 24 months, 36 months

percent change in high-sensitivity C-reactive protein (hs-CRP)

Change in Systolic Blood Pressure (SBP) at 12 months, 24 months, 36 months

number of the Side Effects and /or Complications of each surgical procedure

Guangdong Provincial People's Hospital

The First Hospital of Jilin University

Shanghai Jiao Tong University School of Medicine

Guangdong Provincial Hospital of Traditional Chinese Medicine

Korea University Ansan Hospital

Korea University Anam Hospital

Gastroesophageal Reflux

Patients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection.

Patients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy.

Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced.

Billroth-I

Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced.

Roux en Y

Hoon Hur, M.D.

Sang-Uk Han, M.D.

Jun Young Kim, M.D.

Sang-Uk Han, M.D., Ph.D.

Young Bae Kim, M.D.

Sun Mi Uhm, N.R.

Sang-Uk Han, M.D., Ph D.

The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer

Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure.

Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.

Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy

Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy for Gastric Cancer Patients : Prospective Randomized Study

We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale.

We investigate the quality of life with EORTC-C30, EORTC-STO22 questionnaire suggested by European Organization for Research and Treatment of Cancer (EORTC).

We investigate the occurrence of complication during recovery after surgery.

We estimate Albumin, transferrin, lymphocyte, body weight

We investigate the occurrence of operation-related death during recovery after surgery.

Ajou University School of Medicine

Department of Surgery

Infections

Communicable Diseases

Participants who are diagnosed with gastric cancer and Helicobacter Pylori infection will be treated with subtotal gastrectomy.

1. Pre-operation (initial diagnosis) Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori
2. Post-subtotal gastrectomy (After 6 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.
3. Post-subtotal gastrectomy (After 12 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.
4. Post-subtotal gastrectomy (After 24 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.

Endoscopic biopsy

myungeun Lee, BA

Sojung Park, BA

myungeun lee, BA

Ji Yong Ahn, Professor

The purpose of this study is to know the distribution of Helicobacter pylori in stomach before subtotal gastrectomy and after subtotal gastrectomy.

Endoscopy and biopsy will be performed to investigate the distribution of Helicobacter pylori before and after subtotal gastrectomy.

Distribution of Helicobacter Pylori After Gastrectomy

Distribution of Helicobacter Pylori in Remnant Stomach After Subtotal Gastrectomy

Analysis the change of Helicobacter pylori according to the subtotal gastrectomy

Analysis the change of atrophic status according to the subtotal gastrectomy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study	NCT03978481	Gastric Cancer	Helicobacter py...	19 Years -	Seoul National University Bundang Hospital
Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer	NCT01002443	Gastric Cancer	Helicobacter py... placebo	18 Years - 70 Years	National Cancer Center, Korea
Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery	NCT04284943	Gastric Cancer Diabetes Mellit...	Long limb Roux-... Conventional Ro... Billroth II rec...	20 Years - 69 Years	Korea University Anam Hospital
Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study	NCT03978481	Gastric Cancer	Helicobacter py...	19 Years -	Seoul National University Bundang Hospital
Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy	NCT01142271	Gastrectomy	Billroth-I Roux en Y	20 Years - 75 Years	Ajou University School of Medicine
Distribution of Helicobacter Pylori After Gastrectomy	NCT03419936	Helicobacter Py...	Endoscopic biop...	19 Years - 75 Years	Asan Medical Center
Distribution of Helicobacter Pylori After Gastrectomy	NCT03419936	Helicobacter Py...	Endoscopic biop...	19 Years - 75 Years	Asan Medical Center
Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study	NCT03978481	Gastric Cancer	Helicobacter py...	19 Years -	Seoul National University Bundang Hospital
Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer	NCT01002443	Gastric Cancer	Helicobacter py... placebo	18 Years - 70 Years	National Cancer Center, Korea
Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery	NCT04284943	Gastric Cancer Diabetes Mellit...	Long limb Roux-... Conventional Ro... Billroth II rec...	20 Years - 69 Years	Korea University Anam Hospital

Spots Global Cancer Trial Database for subtotal gastrectomy