Clinical trial NCT01996059: Functional Jejunal Interposition Improve Nutritional Status After Total Gastrectomy
Official title: A Multi-center Pilot Randomized Controlled Trial Examining the Differences of Nutritional Status of Patients Undergoing Functional Jejunal Interposition Or Roux-en-Y After Total Gastrectomy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Nutrition Disorders
Keywords: nutritional status
functional jejunal interposition
Roux-en-Y
gastrectomy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 500
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 purpose of this study is to find out whether the nutritional status of patients undergoing Functional Jejunal Interposition is better than those with Roux-en-Y After Total Gastrectomy for Gastric Cancer. To find a better reconstruction for patients who received total gastrectomy.

Detailed description: Surgery is the only curative way for gastric cancer to date. Methods of Resection and reconstruction are closely related to prognosis and nutritional status. Therefore, it is essential to choose. At present, more and more clinical centers tend to choose Roux-en-Y (RY) reconstruction after total gastrectomy, which are prone to a variety of complications, and seriously affects the quality of life, such as malnutrition. There is argument over whether functional jejunal interposition is better than those with Roux-en-Y After total gastrectomy for gastric cancer. How to improve the nutritional status of the patients following total gastrectomy with gastrointestinal reconstruction arouses people's attention. The purpose of this study was to evaluate differences of the nutritional status in patients undergoing functional jejunal interposition and Roux-en-Y after total gastrectomy.

Eligibility criteria: Inclusion Criteria:

* Untreated patients with curative resectable gastric cancer (A)a clear pathological diagnosis (B)the surgeon and radiologist assess the possibility of removal (C)no previous history of other malignancies. (D)the patient has signed an informed consent form (E)cardiopulmonary and kidney function is normal (F)ECOG body condition scores 0 to 1 (G)does not require emergency surgery

Exclusion Criteria:

- (A) pregnant or lactating women; (B) of the liver, lung, bone, and other distant metastasis; (C) positive supraclavicular lymph nodes, pelvic or ovarian species, peritoneal dissemination, etc.; (D) massive ascites, cachexia; (E) with other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poor merger control hypertension, diabetes; (F) mental disorder or disease; (G) 4 weeks prior to enrollment participated or are participating in other clinical trials of patients; (H) had undergone surgery, and its influence has not been eliminated for patients; (I) a history of stomach or esophagus cancer, including stromal tumors, sarcoma, lymphoma, carcinoid; (J) combined with active infection in patients (infection caused by fever above 38 ℃); (K) in patients with poor compliance or poor patient compliance investigators to consider; (L) Some researchers believe that other clinical, laboratory conditions patients should not participate in the trial.

Primary outcomes:
measure: Body Mass Index
timeFrame: 3 months
Secondary outcomes:
measure: Onodera Prognosis Nutritional Index
timeFrame: 3 months
Other outcomes:
measure: Visick rates
timeFrame: 3 months
Locations:
city: Guangzhou
country: China
facility: the 6th Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Gastrointestinal Surgery
name: Junsheng Peng, professor
role: PRINCIPAL_INVESTIGATOR
References: