Impact of Gastric Tube Reconstruction Widths on Quality of Life for Esophagogastric Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01911832|
Recruitment Status : Unknown
Verified September 2016 by Ziqiang Wang,MD, West China Hospital.
Recruitment status was: Recruiting
First Posted : July 30, 2013
Last Update Posted : September 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms Esophageal Neoplasms||Procedure: esophagojejunostomy after total gastrectomy Procedure: Roux-en-Y gastrojejunostomy after subtotal gastrectomy Procedure: wide tube reconstruction after subtotal gastrectomy Procedure: narrow tube reconstruction after subtotal gastrectomy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Widths After Gastric Tube Reconstruction on Quality of Life for Patients With Esophagogastric Cancers|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||February 2017|
Experimental: Gastrectomy and subtotal gastrectomy
to compare the quality of life between esophagojejunostomy after total gastrectomy(TG group) and Roux-en-Y gastrojejunostomy after subtotal gastrectomy(SG group)
Procedure: esophagojejunostomy after total gastrectomy
Other Name: total gastrostomy group(TG group)
Procedure: Roux-en-Y gastrojejunostomy after subtotal gastrectomy
Other Name: subtotal gastrectomy(SG group)
Experimental: Wide and narrow reconstruction tube
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
Procedure: wide tube reconstruction after subtotal gastrectomy
Other Name: wide gastric tube group(WG group)
Procedure: narrow tube reconstruction after subtotal gastrectomy
Other Name: narrow gastric tube group(NG group)
- quality of life [ Time Frame: 3 years ]quality of life include: 1)integrated questionnaire of QLQ-STO22 and QLQ-C30. 2)related symptom relief of regurgitation, dysphagia and heartburn et al.
- local recurrence [ Time Frame: 1 year ]
- disease free survival [ Time Frame: 1 year ]the time from operation to confirmed local recurrence, distant metastases, or death due to disease or treatment, whichever occurred first
- metastatic rate [ Time Frame: 1 year ]ratio of the patients with metastasis after the operation
- overall survival [ Time Frame: 1 and 3 years ]the fraction of the person from the operation the death,no matter the reason of the death.
- short-term complication of the surgery [ Time Frame: first 30 day after operation ]complication including pulmonary infection, bleeding and anastomotic leakage et al.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911832
|Contact: Wei M tian, M.D.||+email@example.com|
|Contact: Deng X bing, M.D.||+firstname.lastname@example.org|
|West China hospital, Sichuan University||Recruiting|
|Chengdu, Sichuan, China, 610000|
|Contact: Wang Z qiang, PhD,MD +8618980602028 email@example.com|
|Contact: Zhang Y chuan +8613880412932 firstname.lastname@example.org|
|Principal Investigator: Zhang Bo, PhD,MD|