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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by West China Hospital
Sponsor:
Information provided by (Responsible Party):
Ziqiang Wang,MD, West China Hospital
ClinicalTrials.gov Identifier:
NCT01911832
First received: July 22, 2013
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Widths After Gastric Tube Reconstruction on Quality of Life for Patients With Esophagogastric Cancers

Resource links provided by NLM:


Further study details as provided by West China Hospital:

Primary Outcome Measures:
  • quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    quality of life include: 1)integrated questionnaire of QLQ-STO22 and QLQ-C30. 2)related symptom relief of regurgitation, dysphagia and heartburn et al.


Secondary Outcome Measures:
  • local recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • disease free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    ratio of the patients with metastasis after the operation

  • overall survival [ Time Frame: 1 and 3 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    complication including pulmonary infection, bleeding and anastomotic leakage et al.


Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911832

Contacts
Contact: Wei M tian, M.D. +8613198596090 m.weihx@gmail.com
Contact: Deng X bing, M.D. +8613730677124 xiangbingdeng@gmail.com

Locations
China, Sichuan
West China hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610000
Contact: Wang Z qiang, PhD,MD    +8618980602028    wzqtrial@gmail.com   
Contact: Zhang Y chuan    +8613880412932    20874185@qq.com   
Principal Investigator: Zhang Bo, PhD,MD         
Sponsors and Collaborators
West China Hospital
  More Information

Publications:

Responsible Party: Ziqiang Wang,MD, Professor of the West China Hospital, Sichuan University, West China Hospital
ClinicalTrials.gov Identifier: NCT01911832     History of Changes
Other Study ID Numbers: WqLE-201324
Study First Received: July 22, 2013
Last Updated: February 6, 2014
Health Authority: China: Ministry of Health

Keywords provided by West China Hospital:
Cancer of the esophagogastric junction
Reconstruction of gastric tube
Quality of life
Width
Regurgitation

Additional relevant MeSH terms:
Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 26, 2014