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Gastric CancerPhase 4NCT01766765

Early Jejunostomy Nutrition Minimizes Time to Chemotherapy

A Phase 4 study testing Jejunostomy and Early oral nutrition in people with Gastric Cancer and Laparoscopic Surgery, run by Jinling Hospital, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Adjuvant chemotherapy (AC) for gastric cancer is known to improve prognosis, and longer time to AC is associated with worse survival. However, most clinical trials mandate that AC is still to commence within 6 to 8 weeks after surgery consideration for malnutrition, postoperative complications and intolerance of AC. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Cancer, Laparoscopic Surgery, Chemotherapy
What is being tested?
Jejunostomy and Early oral nutrition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
Apr 2013to Jun 2014
Phase
Phase 4
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary gastric cancer
  • R0 resection

Who cannot join

  • Metastatic tumor
  • Locally unresectable tumor
  • Previous gastric/enteral resection
  • Age under 18 years or over 70 years
  • Preoperative complete parenteral or enteral nutrition
  • Neo-adjuvant chemotherapy
  • Severe malnutrition
  • Lack of the patient's consent for the trial participation, jejunostomy tube insertion or epidural analgesia

Trial locations and contacts

1 site in 1 country.

Qi Mao, MD/PhD contact

+862580860961

maoqimdphd@gmail.com

Yousheng Li, MD/PhD contact

+862580860137

liys@medmail.com.cn

China1 site

  • Jinling Hospital

    Nanjing, Jiangsu, 210002

    Qi Mao, MD/PhD

Other trials in China

About this study

Official title: Fast-track Surgery Recovery Program With Early Jejunostomy Nutrition Protocol Minimizes Time to Adjuvant Chemotherapy in Patients Undergoing Laparoscopic Gastrectomy for Gastric Cancer

Adjuvant chemotherapy (AC) for gastric cancer is known to improve prognosis, and longer time to AC is associated with worse survival. However, most clinical trials mandate that AC is still to commence within 6 to 8 weeks after surgery consideration for malnutrition, postoperative complications and intolerance of AC. Placement of jejunostomy nutrition tube for enteral nutrition is a common component of these procedures, as a result of superior postoperative organ function, decreased infection rates, and a greater likelihood to complete AC with enteral nutritional support.

Fast-track surgery (FTS) recovery program focuses on enhancing recovery and reducing morbidity. Introduction of FTS concepts are safe, feasible, and can achieve shorter hospital stays and reduced costs. Early postoperative enteral nutrition combined with FTS results in reductions in total complications compared with traditional postoperative feeding practices and does not negatively affect outcomes. However, the benefit of jejunostomy nutrition tube routine placement and combination with FTS is still being debated. Besides, there remains some controversy over the optimal combination of nutrients and duration and timing and routes of feed administration.

The aim of this study was to determine whether FTS with early jejunostomy nutrition (EJN) following laparoscopic gastrectomy for gastric cancer improved postoperative recovery and minimizes time to AC when compared with FTS with early oral nutrition (EON).

Being tested
Jejunostomy, Early oral nutrition
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JejunostomyProcedure or surgery

    Routine placement of jejunostomy tube following laparoscopic gastrectomy for gastric cancer. Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube

  • Early oral nutritionOther

    Free oral nutrition as tolerance allows on POD 1.

Study groups in NCT01766765
Study groupRoleWhat they receive
Early jejunostomy nutritionExperimentalNot described
Receives: Procedure: Jejunostomy
Early oral nutritionActive comparatorNot described
Receives: Other: Early oral nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The time to the first adjuvant chemotherapy

    Measured: 30 days after operation

Secondary outcomes (9)

  1. Overall morbidity rate of jejunostomy nutrition

    Measured: 60 days after operation

  2. Overall morbidity rate of early oral nutrition

    Measured: 60 days after operation

  3. Postoperative mortality rate

    Measured: 60 days after operation

  4. Time to tolerate EJN/EON

    Measured: 30 days after operation

  5. Time to full oral nutrition

    Measured: 30 days after operation

  6. Body composition

    Measured: 10 days after operation

  7. Energy metabolism

    Measured: 10 days after operation

  8. Postoperative hospital stay length

    Measured: 60 days after operation

  9. Rehospitalization rate

    Measured: 30 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2014 (estimated)
  4. Study completionJun 2014 (estimated)

Resources

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 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01766765
Sponsor's protocol ID
EEN-001
Status last verified
Jan 2013
First submitted
10 Jan 2013
Last updated
11 Jan 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • GASTRIC (Global Advanced/Adjuvant Stomach Tumor Research International Collaboration) Group; Paoletti X, Oba K, Burzykowski T, Michiels S, Ohashi Y, Pignon JP, Rougier P, Sakamoto J, Sargent D, Sasako M, Van Cutsem E, Buyse M. Benefit of adjuvant chemotherapy for resectable gastric cancer: a meta-analysis. JAMA. 2010 May 5;303(17):1729-37. doi: 10.1001/jama.2010.534.

    PubMed 20442389

  • Biagi JJ, Raphael MJ, Mackillop WJ, Kong W, King WD, Booth CM. Association between time to initiation of adjuvant chemotherapy and survival in colorectal cancer: a systematic review and meta-analysis. JAMA. 2011 Jun 8;305(22):2335-42. doi: 10.1001/jama.2011.749.

    PubMed 21642686

  • Osland E, Yunus RM, Khan S, Memon MA. Early versus traditional postoperative feeding in patients undergoing resectional gastrointestinal surgery: a meta-analysis. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):473-87. doi: 10.1177/0148607110385698. Epub 2011 May 31.

    PubMed 21628607

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Jejunostomy and Early oral nutrition in people with Gastric Cancer and Laparoscopic Surgery, run by Jinling Hospital, China 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 2 inclusion and 8 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 11 Jan 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Qi Mao, MD/PhD (+862580860961, maoqimdphd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The time to the first adjuvant chemotherapy (time frame: 30 days after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01766765, which also lists 3 linked publications.

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 11 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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