Gastric CancerNCT06690112
Pilot Study for High Output Drainage Removal After Gastrectomy
A study testing Arm I (Drainage tube removal) in people with Gastric Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
*Objective: The study aims to evaluate whether there is a difference in intra-abdominal complication rates between patients discharged with or without a drainage tube following gastrectomy with high postoperative drainage (≥300ml/day). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Arm I (Drainage tube removal)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2024to 31 Jul 2025
- Phase
- Interventional
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients pathologically diagnosed with gastric adenocarcinoma before surgery.
- Patients eligible for complete surgical resection (R0 resection).
- Patients with an ASA (American Society of Anesthesiologists) score of 3 or lower.
- Patients with more than 300 ml of drainage in the 24 hours on the postoperative day 4.
Who cannot join
- Patients aged 80 or older.
- Patients with stage IV gastric cancer.
- Patients with ascites due to peritoneal metastasis.
- Patients with evident intra-abdominal complications following surgery.
- Patients who require the insertion of additional percutaneous drainage due to insufficient drainage.
- Patients who underwent incomplete gastric resection (R1 or R2 resection).
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- Patients diagnosed with cancers other than gastric cancer.
- Patients with a history of major intra-abdominal surgery or abdominal radiotherapy that may hinder the normal absorption of intra-abdominal fluid.
- Patients with more than 500 ml of drainage in the 24 hours on postoperative day 4.
- Patients presenting with any of the following clinical signs or diagnoses:
- Postoperative pancreatic fistula (POPF), defined as drain amylase levels (Drain amylase; D-amy) more than 3 times higher than serum amylase levels (Serum amylase; S-amy).
- Fever exceeding 37.8℃.
- Presence of any of the following clinical markers of inflammation:
- White blood cell count (WBC) > 15,000/μL ii. C-reactive protein > 200 mg/L
- Observation of non-serous drainage fluid, such as:
- Chylous fluid: Milky-colored fluid. ii. Bloody or sanguineous fluid: Intra-abdominal fluid suggestive of ongoing hemorrhage.
- Vulnerable subjects will not be enrolled in the study, including minors, pregnant women, neonates, adults with impaired consent capacity, individuals in institutional facilities, students, employees of medical institutions or research centers, pharmaceutical company employees, military personnel, unemployed persons, impoverished individuals, homeless individuals, terminally ill patients, or patients in emergency situations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severacne Hospital Yonsei University College of Medicine
Seoul
In-Kyu kwon, 82-2-2019-4601, gsirb@yuhs.ac
About this study
Official title: A Pilot Study Comparing the Incidence of Intra-abdominal Complications According to the Removal of the Drainage Tube in Patients With Large Amounts of Drainage After Gastrectomy in Gastric Cancer Patients
*Objective: The study aims to evaluate whether there is a difference in intra-abdominal complication rates between patients discharged with or without a drainage tube following gastrectomy with high postoperative drainage (≥300ml/day).
*Study Design: This is an open-label randomized controlled trial (RCT) involving two groups. Patients will be randomly assigned to either maintain the drainage tube (control) or have it removed (experimental) before discharge. The primary endpoint is the incidence of intra-abdominal complications within one month post-surgery.
Read more
*Participants:
The study targets 60 patients (30 per group) who meet the following criteria:
Diagnosed with gastric adenocarcinoma and underwent curative gastrectomy (R0 resection).
Postoperative drainage of 300-500 ml/day on the 4th day after surgery. Patients with stage IV cancer, peritoneal metastasis, or postoperative complications requiring additional intervention are excluded.
*Methods: All participants will follow standard postoperative care except for the removal or retention of the drainage tube. Follow-up will occur at 1 and 3 weeks post-discharge, with clinical examinations and imaging (if necessary) to monitor for complications such as infection or abscess. The study's total observation period will last four weeks from the surgery date.
*Data Collection: Data will include patient demographics, surgical details, postoperative management, and the occurrence of complications. Drainage volumes will be recorded daily for those discharged with a tube, and tube removal will occur based on specific criteria.
- Conditions
- Gastric Cancer
- Being tested
- Arm I (Drainage tube removal)
- Keywords
- Drainage tube, Gastrectomy, High output
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (Drainage tube removal)Procedure or surgery
During gastrectomy, a drainage tube is placed within the abdominal cavity. In Arm I (the intervention group), the drainage tube will be removed at the bedside. This procedure is a simple intervention that does not require local anesthesia and involves the removal of the drainage tube by cutting the nylon suture.
| Study group | Role | What they receive |
|---|---|---|
| Drainage removal group | Experimental | Patients who remove their draiange tube at discharge Receives: Procedure: Arm I (Drainage tube removal) |
| Drainage maintain group | No intervention | Patients who maintain their draiange tube at discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intra-Abdominal Complications
Complications include infections, abscesses, or any clinically significant intra-abdominal issues that require medical intervention.
Measured: up to 1 month
Secondary outcomes (2)
Drain-Related Complications
The occurrence of complications related to the drainage tube in the control group, such as infection at the insertion site or mechanical issues.
Measured: up to 1month
CRP Level Changes
The comparison of C-reactive protein (CRP) level changes between the intervention and control groups during the 4-week postoperative follow-up. CRP levels will be measured to assess inflammation and potential early signs of complications.
Measured: up to 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (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.
- 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
- Model description
- Open label Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Gyu Kwon, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690112
- Sponsor's protocol ID
- 3-2023-0393
- Status last verified
- Jan 2025
- First submitted
- 29 Oct 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing the Incidence of Intra-abdominal Complications According to the Removal of the Drainage Tube in Patients With Large Amounts of Drainage After Gastrectomy in Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT06690112
- Acronym / sponsor ID
- 3-2023-0393
- Conditions
- Gastric Cancer
- Keywords
- Drainage tube, Gastrectomy, High output
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 15 Nov 2024 (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.
*Objective: The study aims to evaluate whether there is a difference in intra-abdominal complication rates between patients discharged with or without a drainage tube following gastrectomy with high postoperative drainage (≥300ml/day).
*Study Design: This is an open-label randomized controlled trial (RCT) involving two groups. Patients will be randomly assigned to either maintain the drainage tube (control) or have it removed (experimental) before discharge. The primary endpoint is the incidence of intra-abdominal complications within one month post-surgery.
*Participants:
The study targets 60 patients (30 per group) who meet the following criteria:
Diagnosed with gastric adenocarcinoma and underwent curative gastrectomy (R0 resection).
Postoperative drainage of 300-500 ml/day on the 4th day after surgery. Patients with stage IV cancer, peritoneal metastasis, or postoperative complications requiring additional intervention are excluded.
*Methods: All participants will follow standard postoperative care except for the removal or retention of the drainage tube. Follow-up will occur at 1 and 3 weeks post-discharge, with clinical examinations and imaging (if necessary) to monitor for complications such as infection or abscess. The study's total observation period will last four weeks from the surgery date.
*Data Collection: Data will include patient demographics, surgical details, postoperative management, and the occurrence of complications. Drainage volumes will be recorded daily for those discharged with a tube, and tube removal will occur based on specific criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Drainage removal group | Experimental | Procedure: Arm I (Drainage tube removal)Patients who remove their draiange tube at discharge |
| Drainage maintain group | No intervention | –Patients who maintain their draiange tube at discharge |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients pathologically diagnosed with gastric adenocarcinoma before surgery.
- Patients eligible for complete surgical resection (R0 resection).
- Patients with an ASA (American Society of Anesthesiologists) score of 3 or lower.
- Patients with more than 300 ml of drainage in the 24 hours on the postoperative day 4.
Key exclusion criteria (17 listed)
- Patients aged 80 or older.
- Patients with stage IV gastric cancer.
- Patients with ascites due to peritoneal metastasis.
- Patients with evident intra-abdominal complications following surgery.
- Patients who require the insertion of additional percutaneous drainage due to insufficient drainage.
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 |
|---|---|---|
| Arm I (Drainage tube removal)During gastrectomy, a drainage tube is placed within the abdominal cavity. In Arm I (the intervention group), the drainage tube will be removed at the bedside. This procedure is a simple intervention that does not require local anesthesia and involves the removal of the drainage tube by cutting the nylon suture. | Procedure or surgery | Drainage removal group |
Primary outcome
Incidence of Intra-Abdominal Complications
Time frame: up to 1 month
Complications include infections, abscesses, or any clinically significant intra-abdominal issues that require medical intervention.
2 secondary outcomes
Drain-Related Complications
Time frame: up to 1month
CRP Level Changes
Time frame: up to 1month
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 8 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm I (Drainage tube removal) in people with Gastric Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
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 4 inclusion and 17 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 8 Jan 2025. 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 South Korea. 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.
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 In-Kyu Kwon (82-2-2019-4601, gsirb@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intra-Abdominal Complications (time frame: up to 1 month). 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 8 Jan 2025.