- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01996059
Functional Jejunal Interposition Improve Nutritional Status After Total Gastrectomy (FJINS)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Xiaobin Woo, Doctor
- Phone Number: +86 20 38254092
- Email: xiaobinwoo@gmail.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510655
- Recruiting
- the 6th Affiliated Hospital, Sun Yat-sen University
-
Contact:
- Xiaobin Woo, M.D.
- Phone Number: +86 20 38254092
- Email: xiaobinwoo@gmail.com
-
Contact:
- Huixing Luo, M.D.
- Phone Number: +86 20 38254092
- Email: huixingluo@fox.mail
-
Principal Investigator:
- Junsheng Peng, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body Mass Index
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Onodera Prognosis Nutritional Index
Time Frame: 3 months
|
3 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visick rates
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Junsheng Peng, professor, Department of Gastrointestinal Surgery
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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