Gastric CancerPhase 3FJINSNCT01996059
Functional Jejunal Interposition Improve Nutritional Status After Total Gastrectomy
A Phase 3 study testing Functional Jejunal Interposition and Roux-en-Y in people with Gastric Cancer and Nutrition Disorders, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Nutrition Disorders
- What is being tested?
- Functional Jejunal Interposition and Roux-en-Y
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the 6th Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Xiaobin Woo, M.D., +86 20 38254092, xiaobinwoo@gmail.com
Huixing Luo, M.D., +86 20 38254092, huixingluo@fox.mail
About this study
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
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.
Read the 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.
- Conditions
- Gastric Cancer, Nutrition Disorders
- Being tested
- Functional Jejunal Interposition, Roux-en-Y
- Keywords
- nutritional status, functional jejunal interposition, Roux-en-Y, gastrectomy
- Medical subject headings
- Stomach Neoplasms, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Jejunal InterpositionProcedure or surgery
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-YProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Functional Jejunal Interposition | Experimental | 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. Receives: Procedure: Functional Jejunal Interposition |
| Roux-en-Y | Active comparator | 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. Receives: Procedure: Roux-en-Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: 3 months
Secondary outcomes (1)
Onodera Prognosis Nutritional Index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2020 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junsheng Peng,MD, Sun Yat-sen University
- Investigators
- Junsheng Peng, professor, Principal investigator, Department of Gastrointestinal Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996059
- Sponsor's protocol ID
- 2012017
- Acronym
- FJINS
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01996059
- Acronym / sponsor ID
- FJINS / 2012017
- Conditions
- Gastric Cancer, Nutrition Disorders
- Keywords
- nutritional status, functional jejunal interposition, Roux-en-Y, gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Jejunal Interposition | Experimental | Procedure: Functional Jejunal InterpositionFirst, 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 | Active comparator | Procedure: Roux-en-YThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Jejunal InterpositionFirst, 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 or surgery | Functional Jejunal Interposition |
| Roux-en-YThe 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 or surgery | Roux-en-Y |
Primary outcome
Body Mass Index
Time frame: 3 months
1 secondary outcome
Onodera Prognosis Nutritional Index
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junsheng Peng, professor principal investigator
Department of Gastrointestinal Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Functional Jejunal Interposition and Roux-en-Y in people with Gastric Cancer and Nutrition Disorders, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaobin Woo, Doctor (+86 20 38254092, xiaobinwoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013; AzTrials last refreshed its copy on 2 Nov 2026.