Gastric AdenocarcinomaPhase 3NCT07029269
Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer
A Phase 3 study testing ERAS-tubeless group and ERAS-tube group in people with Gastric Adenocarcinoma and Laparoscopic Gastrectomy, run by Zuoyi Jiao at 6 sites in China.
Trial summary
This study aims to compare the effects of using prophylactic abdominal drainage tubes during Enhanced Recovery After Surgery (ERAS) in patients undergoing Laparoscopic Distal Gastrectomy (LDG) for gastric cancer through a multicenter non-inferiority randomized trial. The study is divided into two groups: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Adenocarcinoma, Laparoscopic Gastrectomy, Complications
- What is being tested?
- ERAS-tubeless group and ERAS-tube group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 6 sitesChina
- Study dates
- 16 Jun 2025to 10 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patients' age from 18 to 80 years old;
- Histopathologically confirmed gastric adenocarcinoma;
- Clinical tumor stage of cT1-4N0-3M0;
- Laparoscopic distal gastrectomy approach;
- ECOG score of 0-1;
- Written informed consent
Who cannot join
- Patients with severe concurrent illness or comorbid diseases;
- Patients with severe pyloric obstruction, recurrent or remnant gastric cancer; 3. Patients with perforation, or undergoing emergency surgery;
- 4. Patients with a history of radiotherapy; 5. Patients undergoing complex abdominal surgeries other than laparoscopic cholecystectomy or appendectomy; 6. Patients with peritoneal, hepatic or ovarian metastasis, or simultaneous tumors in other parts of the body preoperatively and intraoperatively; 7. Patients with diabetes and poor recent glycemic control; 8. Patients with autoimmune diseases who have received corticosteroid treatment; 9. Patients with a BMI ≥30 kg/m2 or <18 kg/m2; 10. Patients with gastrointestinal hemorrhage and hemoglobin levels below 90 g/L; 11. Patients with hypoproteinemia and albumin levels below 30 g/L; 12. Patients with portal hypertension; 13. Patients with severe edema or dense fibrosis intraoperatively after neoadjuvant therapy; 14. Patients with intraoperative findings of duodenal invasion; 15. Patients with combined organ resection; 16. Reconstruction different from BillrothⅡand Braun anastomosis; 17. Patients with preoperative pathological examination inconsistent with postoperative result; 18. Declined to participate; 19. Patients with poor compliance and withdrew from the study halfway
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
International Hospital of Pecking University
Beijing, Beijing Municipality, 102206
Ning Ning, M.D., +86-010-69006900, ningning301@126.com
Ning Ning
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Jianxian Lin, M.D., +86-591-83363366, linjian379@163.com
Jianxian Lin
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730000
Zuoyi Jiao, M.D., +86-0931-5190920, jiaozy@lzu.edu.cn
Zuoyi Jiao, M.D.
- Recruiting
Sun Yat-sen University Cancer Center Gansu Hospital
Lanzhou, Gansu, 730000
Dengwen Wei, +86-13919916710, dengwen002@163.com
Dengwen Wei
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Xi'an City, 710061
Lin Fan, M.D., +86-029-85323874, linnet@mail.xjtu.edu.cn
Lin Fan
- Recruiting
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, 310005
Zhiyuan Xu, M.D., +86-0571-88122222, getfar@foxmail.com
Zhiyuan Xu
About this study
Official title: Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer: A Prospective, Multicenter, Non-inferiority, Randomized, Open-label, Controlled Trial
This study aims to compare the effects of using prophylactic abdominal drainage tubes during Enhanced Recovery After Surgery (ERAS) in patients undergoing Laparoscopic Distal Gastrectomy (LDG) for gastric cancer through a multicenter non-inferiority randomized trial. The study is divided into two groups: 1. ERAS-tubeless group: The ERAS protocol without nasogastric decompression, nasojejunal feeding or prophylactic abdominal drainage tubes. 2. ERAS-tube group: the ERAS protocol with prophylactic abdominal drainage tubes, along with no nasogastric decompression or nasojejunal feeding tubes. Patients will be randomly assigned to the two groups in a 1:1 ratio, with the primary analysis based on the modified intention-to-treat population (mITT) and secondary analysis on the per-protocol (PP) population. Perioperative management will adhere to ERAS guidelines, and postoperative quality of life will be assessed using the EORTC QLQ-C30 questionnaire and QoR-15 scores. Preliminary training on the standard ERAS protocol is administered to all members in the team before the initiation of the study, ensuring in-group members to fully master the requirements and other related contents in the study. Data collectors, analysts, and outcome evaluators will remain blinded to group allocation. The findings of this study are expected to provide high-quality evidence on the feasibility of omitting prophylactic abdominal drainage in the context of ERAS, thereby contributing to the optimization of postoperative management strategies for gastric cancer surgery.
- Being tested
- ERAS-tubeless group, ERAS-tube group
- Keywords
- Enhanced Recovery After Surgery, tubeless, gastric adenocarcinoma, laparoscopic distal gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS-tubeless groupProcedure or surgery
Nasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; No abdominal drainage and nasojejunal feeding tubes were placed intraoperatively; None of these 3 tubes were present postoperatively.
ERAS-tube groupProcedure or surgery
Nasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; Nasojejunal feeding tube is not placed intraoperatively; 1 prophylactic abdominal drainage tube is placed at the duodenal stump for LDG and retained postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| ERAS-tubeless group | Experimental | Nasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; No abdominal drainage and nasojejunal feeding tubes were placed intraoperatively; None of these 3 tubes were present postoperatively. Receives: Procedure: ERAS-tubeless group |
| ERAS-tube group | Active comparator | Nasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; Nasojejunal feeding tube is not placed intraoperatively; 1 prophylactic abdominal drainage tube is placed at the duodenal stump for LDG and retained postoperatively. Receives: Procedure: ERAS-tube group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of reoperation and/or percutaneous drainage placement by the 30th postoperative day.
It refers to the total proportion of patients who, by the 30th day after their surgery, undergo either a reoperation or the placement of a percutaneous drainage device. The cumulative incidence considers all patients who experience one or both of these outcomes by the 30th day after surgery, providing insight into the postoperative recovery process.
Measured: The 30th day after surgery
Secondary outcomes (9)
Postoperative hospital stay
Postoperative hospital stay is considered as a period from the time when a patient leaves the operating room to the point of time (8:00 am) on the day of discharge with no intervention treatment provided.
Measured: It is expected to take 6 to 10 days
Overall 30 days morbidity or in hospital if longer than 30 days.
The intraoperative complications include surgery-related complications (intraoperative hemorrhage (≥400 mL) and injury of liver, spleen, pancreas, and other vital organs), pneumoperitoneum-related complications (hypercapnia, mediastinal emphysema, subcutaneous emphysema, and respiratory and circulatory instability caused by pneumoperitonum), and anesthesia-related complications (acute bronchospasm, aspiration, abnormal blood pressure and temperature, and allergic reaction). The postoperative complications are defined as any adverse events requiring surgical or medical interventions after surgery, including surgery-related complications (wound problems, anastomotic leakage, anastomotic hemorrhage, anastomotic stenosis, intra-abdominal hemorrhage, intra-abdominal abscess, ileus, gastroparesis, lymphatic leakage, unscheduled reoperation, and surgery-related readmission) and system-related complications (pulmonary infection, pulmonary embolism, cardio-cerebrovascular complications (includ
Measured: The 30th day after surgery
30 days readmission rate and overall 90 days mortality.
The 30 days readmission rate refers to the proportion of patients who are readmitted to a healthcare facility within 30 days after being discharged, attributable to postoperative complications. It is often used as a quality metric to assess healthcare effectiveness and the likelihood of complications or inadequate discharge planning. A higher readmission rate may indicate potential issues with the quality of care or patient management after discharge. The overall 90 days mortality refers to the proportion of patients who die within 90 days of either being admitted to or discharged from a healthcare facility, directly attributable to gastric cancer progression or surgery-related complications. This metric is used to evaluate the long-term survival rate of patients following their hospitalization and can serve as an indicator of the severity of the condition being treated, the effectiveness of treatment, and the overall healthcare system's ability to manage patients' long-term outcomes.
Measured: Postoperative Day 30 and Day 90
EORTC QLQ-C30
EORTC QLQ-C30 questionnaire scale is used to assess the quality of life in both two groups. The assessment will be performed preoperatively (baseline), and at 7th day and 1 month after surgery.
Measured: Baseline, Postoperative Day 7 and Day 30
Quality of postoperative recovery.
QoR-15 score is applied to evaluate the quality of recovery in both two groups. The evaluation will be conducted preoperatively (baseline), at 1st, 2nd, 3rd, 4th, 5th day after surgery and the day of discharge separately.
Measured: Baseline, Postoperative Day 1, Day 2, Day 3, Day 4, Day 5, and the Day of Discharge
Time to first ambulation, time to first flatus, and time to first liquid diet.
These time are defined as periods from the time when patients first return to the department after surgery to first out-of-bed activities, first anal exhaust, and first drinking sodium chloride aqueous solution separately. Operative time is defined as the interval from skin incision to skin closure.
Measured: It is expected to take 1 to 5 days.
NRS score.
Postoperative pain intensity is evaluated using the NRS score (0-10) and classified as no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10). It is recorded from the day of surgery to the day of discharge.
Measured: The period is from the day of surgery to the day of discharge, which is expected to be approximately 7 days.
PNI value.
The prognostic nutritional index (PNI) is an indicator, used to evaluate the nutritional status of patients and predict the risk of postoperative complications. It is calculated as peripheral blood lymphocyte count (109/L) × 5 + serum albumin value (g/L).
Measured: The period is from the day of surgery to the day of discharge, which is expected to be approximately 7 days.
Medical cost.
It is calculated as the total amount of medical expenses during the hospital stay for patients. The medical costs were strictly controlled in accordance with relevant regulations of the healthcare system, including the sum of all medically related expenses incurred during the patient's stay, such as bed charges, treatment fees, diagnostic and laboratory costs, medication, nursing, supplies, and other related expenses.
Measured: The period is from the date of hospital admission to discharge, which is expected to take approximately 8 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start16 Jun 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion10 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 454 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuoyi Jiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zuoyi Jiao, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029269
- Sponsor's protocol ID
- LanzhouU2H-2025A-540
- Status last verified
- May 2025
- First submitted
- 24 May 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer: A Prospective, Multicenter, Non-inferiority, Randomized, Open-label, Controlled Trial
- ClinicalTrials.gov ID
- NCT07029269
- Acronym / sponsor ID
- LanzhouU2H-2025A-540
- Keywords
- Enhanced Recovery After Surgery, tubeless, gastric adenocarcinoma, laparoscopic distal gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 454 participants (estimated)
- Lead sponsor
- Zuoyi JiaoUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 10 Sep 2028 (estimated)
- First posted
- 19 Jun 2025 (actual)
- 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.
This study aims to compare the effects of using prophylactic abdominal drainage tubes during Enhanced Recovery After Surgery (ERAS) in patients undergoing Laparoscopic Distal Gastrectomy (LDG) for gastric cancer through a multicenter non-inferiority randomized trial. The study is divided into two groups: 1. ERAS-tubeless group: The ERAS protocol without nasogastric decompression, nasojejunal feeding or prophylactic abdominal drainage tubes. 2. ERAS-tube group: the ERAS protocol with prophylactic abdominal drainage tubes, along with no nasogastric decompression or nasojejunal feeding tubes. Patients will be randomly assigned to the two groups in a 1:1 ratio, with the primary analysis based on the modified intention-to-treat population (mITT) and secondary analysis on the per-protocol (PP) population. Perioperative management will adhere to ERAS guidelines, and postoperative quality of life will be assessed using the EORTC QLQ-C30 questionnaire and QoR-15 scores. Preliminary training on the standard ERAS protocol is administered to all members in the team before the initiation of the study, ensuring in-group members to fully master the requirements and other related contents in the study. Data collectors, analysts, and outcome evaluators will remain blinded to group allocation. The findings of this study are expected to provide high-quality evidence on the feasibility of omitting prophylactic abdominal drainage in the context of ERAS, thereby contributing to the optimization of postoperative management strategies for gastric cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS-tubeless group | Experimental | Procedure: ERAS-tubeless groupNasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; No abdominal drainage and nasojejunal feeding tubes were placed intraoperatively; None of these 3 tubes were present postoperatively. |
| ERAS-tube group | Active comparator | Procedure: ERAS-tube groupNasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; Nasojejunal feeding tube is not placed intraoperatively; 1 prophylactic abdominal drainage tube is placed at the duodenal stump for LDG and retained postoperatively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients' age from 18 to 80 years old;
- Histopathologically confirmed gastric adenocarcinoma;
- Clinical tumor stage of cT1-4N0-3M0;
- Laparoscopic distal gastrectomy approach;
- ECOG score of 0-1;
Key exclusion criteria (3 listed)
- Patients with severe concurrent illness or comorbid diseases;
- Patients with severe pyloric obstruction, recurrent or remnant gastric cancer; 3. Patients with perforation, or undergoing emergency surgery;
- 4. Patients with a history of radiotherapy; 5. Patients undergoing complex abdominal surgeries other than laparoscopic cholecystectomy or appendectomy; 6. Patients with peritoneal, hepatic or ovarian metastasis, or simultaneous tumors in other parts of the body preoperatively and intraoperatively; 7. Patients with diabetes and poor recent glycemic control; 8. Patients with autoimmune diseases who have received corticosteroid treatment; 9. Patients with a BMI ≥30 kg/m2 or <18 kg/m2; 10. Patients with gastrointestinal hemorrhage and hemoglobin levels below 90 g/L; 11. Patients with hypoproteinemia and albumin levels below 30 g/L; 12. Patients with portal hypertension; 13. Patients with severe edema or dense fibrosis intraoperatively after neoadjuvant therapy; 14. Patients with intraoperative findings of duodenal invasion; 15. Patients with combined organ resection; 16. Reconstruction different from BillrothⅡand Braun anastomosis; 17. Patients with preoperative pathological examination inconsistent with postoperative result; 18. Declined to participate; 19. Patients with poor compliance and withdrew from the study halfway
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-tubeless groupNasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; No abdominal drainage and nasojejunal feeding tubes were placed intraoperatively; None of these 3 tubes were present postoperatively. | Procedure or surgery | ERAS-tubeless group |
| ERAS-tube groupNasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; Nasojejunal feeding tube is not placed intraoperatively; 1 prophylactic abdominal drainage tube is placed at the duodenal stump for LDG and retained postoperatively. | Procedure or surgery | ERAS-tube group |
Primary outcome
Cumulative incidence of reoperation and/or percutaneous drainage placement by the 30th postoperative day.
Time frame: The 30th day after surgery
It refers to the total proportion of patients who, by the 30th day after their surgery, undergo either a reoperation or the placement of a percutaneous drainage device. The cumulative incidence considers all patients who experience one or both of these outcomes by the 30th day after surgery, providing insight into the postoperative recovery process.
9 secondary outcomes
Postoperative hospital stay
Time frame: It is expected to take 6 to 10 days
Overall 30 days morbidity or in hospital if longer than 30 days.
Time frame: The 30th day after surgery
30 days readmission rate and overall 90 days mortality.
Time frame: Postoperative Day 30 and Day 90
EORTC QLQ-C30
Time frame: Baseline, Postoperative Day 7 and Day 30
Quality of postoperative recovery.
Time frame: Baseline, Postoperative Day 1, Day 2, Day 3, Day 4, Day 5, and the Day of Discharge
Time to first ambulation, time to first flatus, and time to first liquid diet.
Time frame: It is expected to take 1 to 5 days.
NRS score.
Time frame: The period is from the day of surgery to the day of discharge, which is expected to be approximately 7 days.
PNI value.
Time frame: The period is from the day of surgery to the day of discharge, which is expected to be approximately 7 days.
Medical cost.
Time frame: The period is from the date of hospital admission to discharge, which is expected to take approximately 8 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ERAS-tubeless group and ERAS-tube group in people with Gastric Adenocarcinoma and Laparoscopic Gastrectomy, run by Zuoyi Jiao at 6 sites 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 6 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zuoyi Jiao, M.D. (+86-0931-5190920, jiaozy@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of reoperation and/or percutaneous drainage placement by the 30th postoperative day. (time frame: The 30th day after surgery). 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 17 Dec 2025.