Gastrointestinal CancerPhase 4NCT01930318
Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance After Gastrointestinal Laparoscopic Surgery
A Phase 4 study testing parecoxib in people with Gastrointestinal Cancer, run by Jinling Hospital, China at 1 site in China.
Trial summary
It is well established that the resistance to the effects of insulin on glucose metabolism develops with a lot of stress hormone release after surgical trauma. This condition is known as insulin resistance (IR) characterized by hyperglycemia, hyperinsulinemia and lactic acidosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- parecoxib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Sep 2015
- 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
- Patients with gastrointestinal cancer scheduled for gastrointestinal laparoscopic surgery
- Patients between the ages of 18 and 70 yr
- ASA physical status I-II
- Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- Consciousness and ability to cooperate
Who cannot join
- History of alcohol, analgesic, or narcotic abuse
- Used analgesics, neuroleptics, antipsychotic agents, or corticosteroids within 6 hours of surgery
- A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease
- Female with positive pregnancy
- Allergy to conventional NSAIDs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 200002
Wencheng Kong, MD, 15850722032, wenchengkong@gmail.com
Yousheng Li, MD, liys@medmail.com.cn
About this study
Official title: Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance, Tramadol PCA and Early Postoperative Enteral Nutrition in Patients After Gastrointestinal Laparoscopic Surgery
It is well established that the resistance to the effects of insulin on glucose metabolism develops with a lot of stress hormone release after surgical trauma. This condition is known as insulin resistance (IR) characterized by hyperglycemia, hyperinsulinemia and lactic acidosis. Surgical IR not only affect glucose metabolism but also influence protein synthesis, then further exacerbate the depletion of the carbohydrate, fat and protein.
Postoperative pain is a challenging task for patients and surgeons, and it is part of the stress response to trauma and surgery, while the fear of pain can exacerbate the stress response.
The main aim of this study was to invest whether effective postoperative analgesia can reduce the stress response and insulin resistance.
- Conditions
- Gastrointestinal Cancer
- Being tested
- parecoxib
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parecoxibDrug
Also called COX-2 selective inhibitors
4 groups: PCA,Placebo,Placebo-PCA for 2 days after operation, i.v placebo in 2 days after surgery and oral placebo in the day 3 to day 5 after surgery; PCA,placebo,tramadol-PCA for 2 days after operation, i.v placebo in 2 days after surgery, and oral tramadol(0.1g t.i.d.) in the day 3 to day 5 after surgery;PCA,parecoxib,placebo-PCA for 2 days after operation, i.v parecoxib(40mg b.i.d.) in 2 days after surgery,and oral placebo in the day 3 to day 5 after surgery;PCA,parecoxib,celecoxib-PCA for 2 days after operation,i.v parecoxib(40mg b.i.d.) in 2 days after surgery and oral celecoxib(0.2g b.i.d.) in the day 3 to day 5 after surgery
| Study group | Role | What they receive |
|---|---|---|
| PCA,Placebo,Placebo | Placebo comparator | PCA for 2 days after operation, i.v placebo in 2 days after surgery and oral placebo in the day 3 to day 5 after surgery |
| PCA,placebo,tramadol | Placebo comparator | PCA for 2 days after operation, i.v placebo in 2 days after surgery, and oral tramadol in the day 3 to day 5 after surgery |
| PCA,parecoxib,placebo | Experimental | PCA for 2 days after operation, i.v parecoxib in 2 days after surgery,and oral placebo in the day 3 to day 5 after surgery Receives: Drug: parecoxib |
| PCA,parecoxib,celecoxib | Experimental | PCA for 2 days after operation,i.v parecoxib in 2 days after surgery and oral celecoxib in the day 3 to day 5 after surgery Receives: Drug: parecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery
Measured: 5 days after operation
Secondary outcomes (9)
The consumption of total and incremental tramadol after surgery.
Measured: 5 days after operation
The tolerated dose of enteral nutrition every day after surgery
Measured: 5 days after operation
Postoperative inflammatory factors (IL-4, IL-6 and TNF-α) and levels of stress hormone (glucocorticoids and catecholamines) in perioperative period of gastrointestinal laparoscopic surgery
Measured: 5 days after operation
Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients
Measured: 5 days after operation
The time of the first bowel movements and anal exhaust time after surgery
Measured: 5 days after operation or more
Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale
Measured: 5 days after operation
Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus
Measured: 5 days after operation or more
Liver and renal function tests in perioperative period
Measured: 5 days after operation
Self-rating anxiety scale and self-rating questionnaire for depression before surgery
Measured: 1 day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Kong Wencheng, Jinling Hospital, China
- Investigators
- Wencheng Kong, MD, Principal investigator, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930318
- Sponsor's protocol ID
- PTP-IR-EEN-1
- Status last verified
- Nov 2014
- First submitted
- 25 Aug 2013
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu Z, Li Y, Wang J, Li J. Effect of postoperative analgesia on energy metabolism and role of cyclooxygenase-2 inhibitors for postoperative pain management after abdominal surgery in adults. Clin J Pain. 2013 Jul;29(7):570-6. doi: 10.1097/AJP.0b013e318270f97b.
PubMed 23328338
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance, Tramadol PCA and Early Postoperative Enteral Nutrition in Patients After Gastrointestinal Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01930318
- Acronym / sponsor ID
- PTP-IR-EEN-1
- Conditions
- Gastrointestinal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 28 Aug 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.
It is well established that the resistance to the effects of insulin on glucose metabolism develops with a lot of stress hormone release after surgical trauma. This condition is known as insulin resistance (IR) characterized by hyperglycemia, hyperinsulinemia and lactic acidosis. Surgical IR not only affect glucose metabolism but also influence protein synthesis, then further exacerbate the depletion of the carbohydrate, fat and protein.
Postoperative pain is a challenging task for patients and surgeons, and it is part of the stress response to trauma and surgery, while the fear of pain can exacerbate the stress response.
The main aim of this study was to invest whether effective postoperative analgesia can reduce the stress response and insulin resistance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PCA,Placebo,Placebo | Placebo comparator | –PCA for 2 days after operation, i.v placebo in 2 days after surgery and oral placebo in the day 3 to day 5 after surgery |
| PCA,placebo,tramadol | Placebo comparator | –PCA for 2 days after operation, i.v placebo in 2 days after surgery, and oral tramadol in the day 3 to day 5 after surgery |
| PCA,parecoxib,placebo | Experimental | Drug: parecoxibPCA for 2 days after operation, i.v parecoxib in 2 days after surgery,and oral placebo in the day 3 to day 5 after surgery |
| PCA,parecoxib,celecoxib | Experimental | Drug: parecoxibPCA for 2 days after operation,i.v parecoxib in 2 days after surgery and oral celecoxib in the day 3 to day 5 after surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with gastrointestinal cancer scheduled for gastrointestinal laparoscopic surgery
- Patients between the ages of 18 and 70 yr
- ASA physical status I-II
- Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- Consciousness and ability to cooperate
Key exclusion criteria (5 listed)
- History of alcohol, analgesic, or narcotic abuse
- Used analgesics, neuroleptics, antipsychotic agents, or corticosteroids within 6 hours of surgery
- A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease
- Female with positive pregnancy
- Allergy to conventional NSAIDs
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 |
|---|---|---|
| parecoxibAlso: COX-2 selective inhibitors4 groups: PCA,Placebo,Placebo-PCA for 2 days after operation, i.v placebo in 2 days after surgery and oral placebo in the day 3 to day 5 after surgery; PCA,placebo,tramadol-PCA for 2 days after operation, i.v placebo in 2 days after surgery, and oral tramadol(0.1g t.i.d.) in the day 3 to day 5 after surgery;PCA,parecoxib,placebo-PCA for 2 days after operation, i.v parecoxib(40mg b.i.d.) in 2 days after surgery,and oral placebo in the day 3 to day 5 after surgery;PCA,parecoxib,celecoxib-PCA for 2 days after operation,i.v parecoxib(40mg b.i.d.) in 2 days after surgery and oral celecoxib(0.2g b.i.d.) in the day 3 to day 5 after surgery | Drug | PCA,parecoxib,celecoxib, PCA,parecoxib,placebo |
Primary outcome
Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery
Time frame: 5 days after operation
9 secondary outcomes
The consumption of total and incremental tramadol after surgery.
Time frame: 5 days after operation
The tolerated dose of enteral nutrition every day after surgery
Time frame: 5 days after operation
Postoperative inflammatory factors (IL-4, IL-6 and TNF-α) and levels of stress hormone (glucocorticoids and catecholamines) in perioperative period of gastrointestinal laparoscopic surgery
Time frame: 5 days after operation
Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients
Time frame: 5 days after operation
The time of the first bowel movements and anal exhaust time after surgery
Time frame: 5 days after operation or more
Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale
Time frame: 5 days after operation
Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus
Time frame: 5 days after operation or more
Liver and renal function tests in perioperative period
Time frame: 5 days after operation
Self-rating anxiety scale and self-rating questionnaire for depression before surgery
Time frame: 1 day before surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
- Background: PubMed 23328338Xu Z, Li Y, Wang J, Li J. Effect of postoperative analgesia on energy metabolism and role of cyclooxygenase-2 inhibitors for postoperative pain management after abdominal surgery in adults. Clin J Pain. 2013 Jul;29(7):570-6. doi: 10.1097/AJP.0b013e318270f97b.
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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.
Wencheng Kong, MD principal investigator
Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing parecoxib in people with Gastrointestinal Cancer, 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 5 inclusion and 5 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 10 Nov 2014. 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. Some participants in this study may receive a placebo. 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 Wengcheng Kong, MD (15850722032, wenchengkong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery (time frame: 5 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 NCT01930318, which also lists 1 linked publication.
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 10 Nov 2014.