Clinical trial NCT01911832: Impact of Gastric Tube Reconstruction Widths on Quality of Life for Esophagogastric Cancers
Official title: Impact of Widths After Gastric Tube Reconstruction on Quality of Life for Patients With Esophagogastric Cancers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stomach Neoplasms
Esophageal Neoplasms
Keywords: Cancer of the esophagogastric junction
Reconstruction of gastric tube
Quality of life
Width
Regurgitation
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. pathologically confirmed esophagogastric cancers
2. age between 18 to 80 years
3. no evidence of metastasis of adjacent organs
4. organs function well to tolerate surgery
5. no special treatment before surgery
6. informed consent was written

Exclusion Criteria:

1. with other site tumor,simultaneously
2. locally recurrent gastric or esophageal cancer
3. had a history of malignant tumor within 5 years(except the skin cancer)
4. pregnant or lactating women
5. there was contraindication for operation
6. discovery of metastasis in the operation
7. with mental disorder

Primary outcomes:
measure: quality of life
timeFrame: 3 years
Secondary outcomes:
measure: local recurrence
timeFrame: 1 year
measure: disease free survival
timeFrame: 1 year
measure: metastatic rate
timeFrame: 1 year
measure: overall survival
timeFrame: 1 and 3 years
measure: short-term complication of the surgery
timeFrame: first 30 day after operation
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China hospital, Sichuan University
state: Sichuan
Study officials:
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