Gastric CancerERASAGNCT02348229
Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins
A study testing ERAS protocols and conventional pathway group in people with Gastric Cancer, run by The First Hospital of Jilin University.
Trial summary
The investigators designed a prospective randomized, controlled clinical trial then recruited 149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73) and a conventional pathway group (n=76). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- ERAS protocols and conventional pathway group
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Oct 2014
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old
- Diagnosis confirmed by the endoscopic biopsy and total-body CT scan
- No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3
- No neoadjuvant chemotherapy and radiotherapy
- No digestive obstruction and distant metastasis
Who cannot join
- Conversion to open gastrectomy
- A large amount of bleeding leading(>500ml)
- Patients withdrew their consent
About this study
Official title: Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins in Patients With Advanced Gastric Cancer
The investigators designed a prospective randomized, controlled clinical trial then recruited 149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73) and a conventional pathway group (n=76). Surgical technique in both groups was same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included clinical parameters and serum indicators.
Read the detailed description
Enhanced recovery after surgery combined with laparoscopic-assisted gastrectomy was successfully carried out in this study. Recovery parameters such as the length of time to return to normal diet,mean hospital stay (d) were recorded.
- Conditions
- Gastric Cancer
- Being tested
- ERAS protocols, conventional pathway group
- Keywords
- Enhanced recovery after surgery, laparoscopic gastrectomy, advanced gastric cancer, C-reactive,visceral proteins
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolsProcedure or surgery
Normal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery
ERAS protocolsProcedure or surgery
No bowel preparation
ERAS protocolsProcedure or surgery
No nasogastric placement; if used, remove on the 1st postoperative day
ERAS protocolsProcedure or surgery
Vasoactive drugs used if need be
ERAS protocolsProcedure or surgery
Temperature management
ERAS protocolsProcedure or surgery
Intra-abdominal drains not to be used
ERAS protocolsProcedure or surgery
Intraperitoneal Ropivicaine infusion
ERAS protocolsProcedure or surgery
On the 1st postoperative day Nasogastric catheter removed /Urinary catheter removed.
Oral non-opioid analgesia/Drinking 0.5L liquid. Active mobilisation
ERAS protocolsProcedure or surgery
On the 2nd postoperative day：Drains removed Oral diet was initiated
ERAS protocolsProcedure or surgery
3-4th postoperative day： Stop oral non opioid analgesia
ERAS protocolsProcedure or surgery
On the5-6th postoperative day Check discharge criteria
conventional pathway groupProcedure or surgery
No solid foods at dinner before surgery and no liquids 12 h before surgery. Routine bowel preparation Nasogastric placement on the morning of surgery
conventional pathway groupProcedure or surgery
Routine use of anesthesia medicine. Standard 5-trocar laparoscopy-assisted procedure. I.V. fluids not restricted (Ringer's lactate 20 ml/kg in the first hour, then at the rate of 10-12 ml/kg/h) Routine use of abdominal drainage tubes and placement of catheters.
conventional pathway groupProcedure or surgery
1st postoperative day: Keep Nasogastric catheter Removal of urinary catheter Opioid analgesic by intramuscular injection Parenteral nutrition until flatus. I.V. fluids not restricted Mobilization in bed
conventional pathway groupProcedure or surgery
2nd postoperative day Patient is advised to get out of bed until 24-48h after surgery
conventional pathway groupProcedure or surgery
3-4th postoperative day： Remove nasogastric tube after flatus Oral liquids started. Encouraged to walk in the ward.
conventional pathway groupProcedure or surgery
5-6th postoperative day：Oral diet was changed from liquids to semi-fluids and normal food.
Drains removed
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | ERAS protocols Receives: Procedure: ERAS protocols |
| conventional pathway group | Other | using conventional pathway Receives: Procedure: conventional pathway group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compartition of postoperative hospital stay
Measured: up to 30 days after the operation
Secondary outcomes (1)
Change from baseline in C-Reactive Protein( CRP) and visceral proteins level
1day before and 1-5days after operation
Measured: baseline and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionOct 2014
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 Gastric CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quan Wang, Doctor, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348229
- Sponsor's protocol ID
- 2013-212
- Acronym
- ERASAG
- Status last verified
- Jan 2015
- First submitted
- 17 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mingjie X, Luyao Z, Ze T, YinQuan Z, Quan W. Laparoscopic Radical Gastrectomy for Resectable Advanced Gastric Cancer Within Enhanced Recovery Programs: A Prospective Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):959-964. doi: 10.1089/lap.2016.0057. Epub 2016 Nov 22.
PubMed 27875094
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02348229
- Acronym / sponsor ID
- ERASAG / 2013-212
- Conditions
- Gastric Cancer
- Keywords
- Enhanced recovery after surgery, laparoscopic gastrectomy, advanced gastric cancer, C-reactive,visceral proteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Jan 2015 (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 investigators designed a prospective randomized, controlled clinical trial then recruited 149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73) and a conventional pathway group (n=76). Surgical technique in both groups was same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included clinical parameters and serum indicators.
Detailed description
Enhanced recovery after surgery combined with laparoscopic-assisted gastrectomy was successfully carried out in this study. Recovery parameters such as the length of time to return to normal diet,mean hospital stay (d) were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Procedure: ERAS protocolsERAS protocols |
| conventional pathway group | Other | Procedure: conventional pathway groupusing conventional pathway |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years old
- Diagnosis confirmed by the endoscopic biopsy and total-body CT scan
- No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3
- No neoadjuvant chemotherapy and radiotherapy
- No digestive obstruction and distant metastasis
Key exclusion criteria (3 listed)
- Conversion to open gastrectomy
- A large amount of bleeding leading(>500ml)
- Patients withdrew their consent
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 |
|---|---|---|
| ERAS protocolsNormal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery | Procedure or surgery | ERAS group |
| ERAS protocolsNo bowel preparation | Procedure or surgery | ERAS group |
| ERAS protocolsNo nasogastric placement; if used, remove on the 1st postoperative day | Procedure or surgery | ERAS group |
| ERAS protocolsVasoactive drugs used if need be | Procedure or surgery | ERAS group |
| ERAS protocolsTemperature management | Procedure or surgery | ERAS group |
| ERAS protocolsIntra-abdominal drains not to be used | Procedure or surgery | ERAS group |
| ERAS protocolsIntraperitoneal Ropivicaine infusion | Procedure or surgery | ERAS group |
| ERAS protocolsOn the 1st postoperative day Nasogastric catheter removed /Urinary catheter removed. Oral non-opioid analgesia/Drinking 0.5L liquid. Active mobilisation | Procedure or surgery | ERAS group |
| ERAS protocolsOn the 2nd postoperative day：Drains removed Oral diet was initiated | Procedure or surgery | ERAS group |
| ERAS protocols3-4th postoperative day： Stop oral non opioid analgesia | Procedure or surgery | ERAS group |
| ERAS protocolsOn the5-6th postoperative day Check discharge criteria | Procedure or surgery | ERAS group |
| conventional pathway groupNo solid foods at dinner before surgery and no liquids 12 h before surgery. Routine bowel preparation Nasogastric placement on the morning of surgery | Procedure or surgery | conventional pathway group |
| conventional pathway groupRoutine use of anesthesia medicine. Standard 5-trocar laparoscopy-assisted procedure. I.V. fluids not restricted (Ringer's lactate 20 ml/kg in the first hour, then at the rate of 10-12 ml/kg/h) Routine use of abdominal drainage tubes and placement of catheters. | Procedure or surgery | conventional pathway group |
| conventional pathway group1st postoperative day: Keep Nasogastric catheter Removal of urinary catheter Opioid analgesic by intramuscular injection Parenteral nutrition until flatus. I.V. fluids not restricted Mobilization in bed | Procedure or surgery | conventional pathway group |
| conventional pathway group2nd postoperative day Patient is advised to get out of bed until 24-48h after surgery | Procedure or surgery | conventional pathway group |
| conventional pathway group3-4th postoperative day： Remove nasogastric tube after flatus Oral liquids started. Encouraged to walk in the ward. | Procedure or surgery | conventional pathway group |
| conventional pathway group5-6th postoperative day：Oral diet was changed from liquids to semi-fluids and normal food. Drains removed | Procedure or surgery | conventional pathway group |
Primary outcome
Compartition of postoperative hospital stay
Time frame: up to 30 days after the operation
1 secondary outcome
Change from baseline in C-Reactive Protein( CRP) and visceral proteins level
Time frame: baseline and 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
- Derived from this study: PubMed 27875094Mingjie X, Luyao Z, Ze T, YinQuan Z, Quan W. Laparoscopic Radical Gastrectomy for Resectable Advanced Gastric Cancer Within Enhanced Recovery Programs: A Prospective Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):959-964. doi: 10.1089/lap.2016.0057. Epub 2016 Nov 22.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Quan Wang, Doctor study director
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocols and conventional pathway group in people with Gastric Cancer, run by The First Hospital of Jilin University.
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 3 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: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compartition of postoperative hospital stay (time frame: up to 30 days after the 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 NCT02348229, 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 28 Jan 2015.