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New treatment option for Gastric Cancer
Official title Pilot Study for High Output Drainage Removal After Gastrectomy
ClinicalTrials.gov ID: NCT06690112
What this study is testing
- What it's testing
- \ 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility criteria
- 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.
- 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).
- 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: i. White blood cell count (WBC) \> 15,000/μL ii. C-reactive protein \> 200 mg/L
- Observation of non-serous drainage fluid, such as: i. Chylous fluid: Milky-colored fluid. ii. Bloody or sanguineous fluid: Intra-abdominal fluid suggestive of ongoing hemorrhage.
- Vulnerable people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.