Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Esophageal Neoplasms

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Quality of Life

Stomach Cancer

to compare the quality of life between esophagojejunostomy after total gastrectomy(TG group) and Roux-en-Y gastrojejunostomy after subtotal gastrectomy(SG group)

to compare the quality of life between wide tube reconstruction after subtotal gastrectomy(WG group) and narrow tube reconstruction after subtotal gastrectomy(NG group) in Roux-en-Y gastrojejunostomy

esophagojejunostomy after total gastrectomy

Roux-en-Y gastrojejunostomy after subtotal gastrectomy

wide tube reconstruction after subtotal gastrectomy

narrow tube reconstruction after subtotal gastrectomy

Wei M tian, M.D.

Deng X bing, M.D.

Wang Z qiang, PhD,MD

Zhang Y chuan

Zhang Bo, PhD,MD

The incidence of cancer of the esophagogastric junction has rapidly risen in recent three decades, and surgery still remains the optimum therapy. For Siewert's type II and III cancer, esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy are regarded as the two main surgical approaches. Esophagojejunostomy after total gastrectomy brings high survival rate and low local recurrence rate which may also induces pulmonary infection or regurgitation. Roux-en-Y gastrojejunostomy after subtotal gastrectomy needs reconstruction of the gastric tube and the width of reconstruction tube was a key factor to predicate prognosis. However, no evidence supplies a comprehensive standard on the width of reconstruction tube which often ranges from 3 cm to 6 cm. Both narrow and wide reconstruction tubes have their own advantages and disadvantages. So the prospective trail recruits patients into three groups: total gastrostomy group (TG group), wide gastric tube group (WG group) and narrow gastric tube group (NG group). And the investigators compare the quality of life using integrated questionnaire of QLQ-STO22 and QLQ-C30 and related symptom relief as main endpoints.

With the decreasing prevalence of gastric cancer, the incidence of cancer of the esophagogastric junction has rapidly risen in recent three decades, especially in North America and Europe. Despite the use of chemotherapy, its 5-year survival rate is still low (less than 30%) for cancer of the esophagogastric junction. Surgery still remains the optimum therapy for cancer of the esophagogastric junction. For Siewert's type II and III cancer, esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy are regarded as the two main surgical approaches. For quality of life, no prospective trial provides evidence comparing the two approaches.

With a complete clearance of lymph nodes, esophagojejunostomy after total gastrectomy brings high 5-year survival rate, and can decrease the rate of local recurrence. However, due to the whole gastrectomy, the patients often represent bile regurgitation which may induce pulmonary infection, regurgitation asthma and weight loss.

Roux-en-Y gastrojejunostomy after subtotal gastrectomy reserve partial gastric body which was reconstructed into gastric tube. The remaining gastric body still peristalses and functions as well as a stomach. At the same time, the remaining gastric body keeps acid-secreting function which may induce acid regurgitation after surgery.

For Roux-en-Y gastrojejunostomy after subtotal gastrectomy, the width of reconstruction gastric tube was a key factor to predicate prognosis, and it often ranges from 3 cm to 6 cm, without universal standard. Narrow gastric tube may lack enough blood supply, as a result, it increase the rate of anastomotic leakage. On the contrary, wide gastric tube takes up much thoracic capacity which may disturb the normal pulmonary and cardiovascular function. Tabira and his colleagues conduct a prospective trail that proves the width of gastric tube has no relevance to local blood supply, anastomotic leakage and postoperative nutrition, but the study lack enough patients which may increase bias. So, there is no reliable evidence to predict the quality of postoperative life.

The prospective trail recruits patients with of cancer of the esophagogastric junction. And eligible patients were assigned into three groups: total gastrostomy group (TG group), wide gastric tube group (WG group) and narrow gastric tube group (NG group). Quality of life include integrated questionnaire of QLQ-STO22 and QLQ-C30 and related symptom relief was assessed as primary endpoint. And local recurrence, disease free survival, metastatic rate, overall survival and short-term complication of surgery were also observed as secondary endpoints.

Impact of Gastric Tube Reconstruction Widths on Quality of Life for Esophagogastric Cancers

Impact of Widths After Gastric Tube Reconstruction on Quality of Life for Patients With Esophagogastric Cancers

quality of life include: 1)integrated questionnaire of QLQ-STO22 and QLQ-C30. 2)related symptom relief of regurgitation, dysphagia and heartburn et al.

the time from operation to confirmed local recurrence, distant metastases, or death due to disease or treatment, whichever occurred first

ratio of the patients with metastasis after the operation

the fraction of the person from the operation the death,no matter the reason of the death.

complication including pulmonary infection, bleeding and anastomotic leakage et al.

West China Hospital

Professor of the West China Hospital, Sichuan University

Symptoms and General Pathology

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Nutritional and Metabolic Diseases

Weight Loss

Constipation

Diarrhea

Anorexia

Pain

Gastroesophageal Reflux

Body Weight

Nausea

Vomiting

Deglutition Disorders

Mucositis

Exocrine Pancreatic Insufficiency

Malabsorption Syndromes

Flatulence

Steatorrhea

Gastrointestinal Agents

All Drugs and Chemicals

Bile Acids and Salts

The study will be limited to NHS patients to reduce complications associated with the need for additional funding authorisations from private health care providers for algorithm-instigated investigations. It is not envisaged that participation in other studies running within the GI unit at The Royal Marsden Hospital will preclude entry into this study except in the event of those rare studies where the study is specifically measuring toxicity of treatment as the primary end point.

Jervoise Andreyev, MBBS, Ph.D

Linda Wedlake, RD MSc BSc

The aim of the study is to identify how often gastrointestinal problems interfere with quality of life as a result of treatment for cancer with chemotherapy. We also want to identify the causes for these symptoms and see if simple treatments used for other gastrointestinal conditions could make chemotherapy an easier experience. Chemotherapy for cancer can be hard work for the patient. Often it makes them feel tired. Not infrequently, it can cause a whole range of physical side effects. Probably the most common side effects are those affecting the stomach and bowels. Vomiting used to be a major problem with chemotherapy but research discovered a whole series of new treatments so that severe vomiting from chemotherapy is rarely a problem today. However, patients can develop a whole series of other symptoms during chemotherapy, for example, bloating, wind, diarrhoea, needing to rush to the lavatory and opening the bowels very frequently. The causes for these symptoms have hardly been studied even though they sometimes affect people quite badly. In our specialist gastrointestinal clinic at the Royal Marsden Hospital, over the last 12 years, we have pioneered new methods for dealing with symptoms which affect the bowel after radiotherapy. We would like to extend these methods to people having chemotherapy. We have identified several easily treatable causes for these symptoms after radiotherapy, which previously were often ignored. We believe that some of these causes also occur in people having chemotherapy and if we knew how often they do occur we could focus on improving treatment for affected people. We plan to find out how often 40 stomach and bowel symptoms occur during chemotherapy. In people who are troubled by any or some of these symptoms we will arrange simple series tests which could sort out why these symptoms occur and we will record how they respond to treatment.

Chemotherapy (CT) remains an integral part of treatment for many types of cancer often in combination with surgery and/or radiotherapy. In the year March 2011 to April 2012, 1807 patients were referred to the Royal Marsden Hospital (RMH) Gastrointestinal Unit with a new gastro intestinal (GI) cancer of whom 709 were treated with chemotherapy alone or in combination with other long term outcome. GI symptoms are common in patients receiving chemotherapy. They may arise from the tumour, but may also result as a side effect of treatment. They include anorexia, borborygmi, bloating, constipation, diarrhoea, dysphagia, early satiety, frequency of defaecation, incontinence, mucus discharge, nausea, nocturnal defaecation, pain, reflux, regurgitation, steatorrhoea, tenesmus, urgency of defaecation, vomiting, weight loss and wind. Frequently, such symptoms have a significant impact on patients' quality of life. They may also interfere with the delivery of treatment prompting cessation of therapy or dose reduction resulting in sub optimal dosage with a potential impact on morbidity and mortality. Whilst clinicians have long focused on the management of vomiting and pain in cancer patients, less attention has been paid to the incidence, severity or optimal management of other GI symptoms. If the cause of these symptoms can be identified, then appropriate investigations and treatments can be prescribed. The GI Unit has successfully investigated and treated patients with symptoms emerging after radiotherapy. This experience has enabled the team to develop an algorithm for facilitating the investigation and treatment of cancer therapy induced symptoms. The algorithm has recently been shown to be effective in the management of patients with radiation induced bowel injury . In particular, it enables the rapid identification of required investigations and improves the management of symptoms that might otherwise be mislabeled as inevitable consequences of treatment. Five easily treatable causes for GI symptoms have so far been identified:

* Small bowel bacterial overgrowth
* Carbohydrate malabsorption
* Bile acid malabsorption
* Gastric bile reflux
* Pancreatic insufficiency

It is likely that additional causes such as viral infections (eg cytomegalovirus) are more frequent in patients undergoing chemotherapy than currently appreciated.

Blood and Stool Samples will be collected for translational analysis.

The FOCCUS Study: "Focusing on Cancers Chemotherapys' Untreated Symptoms"

The FOCCUS Study: "Focusing on Cancer Chemotherapys' Untreated Symptoms"

Royal Marsden NHS Foundation Trust

Constriction, Pathologic

Esophageal Stenosis

Pathological Conditions, Anatomical

EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve

EndoMAXX Endoluminal Valve Technology (EVT)

EndoMAXX

Kulwinder DUA, MD

This is a prospective, single blinded, randomized study of EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve for the treatment of malignant strictures of the lower esophagus. The purpose of this study is to evaluate improvement of dysphagia due to esophageal stricture with EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).

EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

Prospective, Multicenter, Single Blind, Randomized Study Comparing the EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent With Valve to the EndoMAXX Fully Covered Esophageal Stent for Malignant Strictures Requiring Stent Placement Across the Gastroesophageal Junction

The primary endpoint is to evaluate improvement of dysphagia due to esophageal strictures at 2 weeks following treatment.

Scale:

0 = able to eat normal diet / no dysphagia.

1. = able to swallow some solid foods
2. = able to swallow only semi solid foods
3. = able to swallow liquids only
4. = unable to swallow anything / total dysphagia

Evaluate symptoms of gastric reflux as assessed by Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument at 4 weeks following treatment.

Scale:

0 = No symptom

1. = Symptoms noticeable but not bothersome
2. = Symptoms noticeable and bothersome but not every day
3. = Symptoms bothersome every day
4. = Symptoms affect daily activity
5. = Symptoms are incapacitating to do daily activities

Geisinger Clinic

Medical College of Wisconsin

Indiana University

University of Colorado, Denver

Mayo Clinic

Weill Medical College of Cornell University

University of Florida

Merit Medical Systems, Inc.

EndoMAXX EVT Fully Covered Esophageal Stent with Valve

EndoMAXX EVT

EndoMAXX EVT

EndoMAXX Fully Covered Esophageal Stent

EndoMAXX

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Casey Holland

1 patient was randomized but not treated and other patients are not included

Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment

EndoMAXX EVT Fully Covered Esophageal Stent with Valve

Results at week 4, number of patients analyzed differs from baseline due to inability to continue to follow the patients due to death or lost to follow up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Gastric Tube Reconstruction Widths on Quality of Life for Esophagogastric Cancers	NCT01911832	Stomach Neoplas... Esophageal Neop...	esophagojejunos... Roux-en-Y gastr... wide tube recon... narrow tube rec...	18 Years - 80 Years	West China Hospital
The FOCCUS Study: "Focusing on Cancers Chemotherapys' Untreated Symptoms"	NCT02121626	Cancer		18 Years - 90 Years	Royal Marsden NHS Foundation Trust
EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX	NCT02159898	Malignant Esoph...	EndoMAXX Endolu... EndoMAXX	18 Years -	Merit Medical Systems, Inc.
EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX	NCT02159898	Malignant Esoph...	EndoMAXX Endolu... EndoMAXX	18 Years -	Merit Medical Systems, Inc.

Spots Global Cancer Trial Database for regurgitation