Functional Jejunal Interposition Improve Nutritional Status After Total Gastrectomy

Gastric Cancer Clinical Trial

— FJINS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01996059
• Other study ID #: 2012017
• Status: Recruiting
• Phase: Phase 3
• First received: November 19, 2013
• Last updated: November 21, 2013
• Start date: July 2012
• Est. completion date: June 2022

Study information

• Verified date: November 2013
• Source: Sun Yat-sen University
• Contact: Xiaobin Woo, Doctor
• Phone: +86 20 38254092
• Email: xiaobinwoo[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2022
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Nutrition Disorders
• Stomach Neoplasms

Intervention

Procedure:
• Functional Jejunal Interposition
First, an end-to-side esophagojejunostomy was performed at 40 cm anal to Treitz's ligament. Then, an end-to-side duodenojejunostomy was created at the efferent limb 35 cm distal to the esophagojejunostomy, followed by a side-to-side jejunostomy at 5 cm distal to duodenojejunostomy and 20 cm distal to Treitz's ligament. Finally, 2 jejunal proper ligations were made at 5 cm oral to esophagojejunostomy and 2 cm distal to duodenojejunostomy.
• Roux-en-Y
The distal end of the duodenum was closed. The jejunum was separated 15-20cm distal to the Treitz's ligament, and an end-to-side esophagojejunostomy was done at the distal side of the jejunum. Then, the continuity of the jejunum was reconstructed with side-to-end jejunojejunostomy at 40-45cm distal to esophagojejunostomy.

Locations

Country	Name	City	State
China	the 6th Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visick rates		3 months	No
Primary	Body Mass Index		3 months	No
Secondary	Onodera Prognosis Nutritional Index		3 months	No