Functional Jejunal Interposition Improve Nutritional Status After Total Gastrectomy (FJINS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Junsheng Peng,MD, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01996059
First received: November 19, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Nutrition Disorders
Procedure: Functional Jejunal Interposition
Procedure: Roux-en-Y
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Onodera Prognosis Nutritional Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Visick rates [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: July 2012
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: 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.
Procedure: 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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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: NCT01996059

Contacts
Contact: Xiaobin Woo, Doctor +86 20 38254092 xiaobinwoo@gmail.com

Locations
China, Guangdong
the 6th Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Xiaobin Woo, M.D.    +86 20 38254092    xiaobinwoo@gmail.com   
Contact: Huixing Luo, M.D.    +86 20 38254092    huixingluo@fox.mail   
Principal Investigator: Junsheng Peng, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Junsheng Peng, professor Department of Gastrointestinal Surgery
  More Information

No publications provided

Responsible Party: Junsheng Peng,MD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01996059     History of Changes
Other Study ID Numbers: 2012017
Study First Received: November 19, 2013
Last Updated: November 21, 2013
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
nutritional status
functional jejunal interposition
Roux-en-Y
gastrectomy

Additional relevant MeSH terms:
Stomach Neoplasms
Nutrition Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 22, 2014