The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled WAter or Saline at High Volumes for Resected Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 845
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The goal of this clinical trial is to learn if a special washing treatment used during surgery can help people with pancreatic cancer live longer. The study includes adults who are having surgery for suspected pancreatic cancer or related cancers in nearby organs (called periampullary cancers).
The main questions it aims to answer are:
- Does the washing treatment improve overall survival (how long patients live)?
- Does it improve how long patients remain cancer-free and reduce cancer recurrence or complications?
The investigators will compare two types of washing treatments and standard care to see if either method improves outcomes.
Participants will:
Be assigned by chance (randomized) before surgery to one of three groups:
- Washing with warm saltwater (saline)
- Washing with sterile water
- No extensive washing (standard care)
Undergo their planned cancer surgery, during which the washing treatment (if assigned) will be performed right after the tumor is removed Be followed over time to monitor survival, cancer recurrence, and any side effects
The investigators estimate the washing treatment could increase average survival from about 18 months to 27 months. To ensure enough patients with confirmed pancreatic cancer are included, about 845 participants will be enrolled over time.
详细描述
PRIMARY OBJECTIVE:
To compare overall survival (OS) following pancreatic resection between subjects receiving extensive abdominal lavage with saline (EAL-S), extensive abdominal lavage with distilled water (EAL-W), and standard of care without extensive lavage.
SECONDARY OBJECTIVES:
I. Disease-free survival (DFS). II. Complication rate. III. Site of first recurrence (by site and distant versus local recurrence). IV. Clearance of malignant cells pre- versus post-lavage.
STUDY DESIGN:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has a surgical indication for pancreatectomy (pancreaticoduodenctomy, distal pancreatectomy, total pancreatectomy) as determined by the treating physician/surgeon
- •A diagnosis of pancreatic or other periampullary cancer is suspected preoperatively
- •In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy
- •Age ≥18 years of age.
- •The subject is willing to consent to randomization of EAL-S vs. EAL-W vs. no extensive lavage (SOC)
排除标准
- •The subject does not have a surgical indication for pancreatectomy
- •In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy
- •Age <18 years of age
- •The subject is not willing to consent to EAL-S vs. EAL-W vs. no extensive lavage (SOC)
- •Known benign or indolent disease (including benign pancreatic cystic tumors or pancreatic endocrine tumors) without possible risk of malignancy
- •Other malignancy within five years, unless the probability of recurrence of the prior malignancy is <5% as determined by the Principal Investigator based on available information. Patient's curatively treated for squamous and basal cell carcinoma of the skin or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
- •Evidence of metastatic disease preoperatively
研究组 & 干预措施
Arm I: Extensive Abdominal Lavage with Saline (EAL-S)
Participants undergo pancreaticoduodenectomy. Immediately after removal of tumor, participants receive EAL-S with 10 L warmed 0.9% normal saline, delivered as 1 L lavage repeated 10 times over 15 minutes.
干预措施: Lavage (Other)
Arm I: Extensive Abdominal Lavage with Saline (EAL-S)
Participants undergo pancreaticoduodenectomy. Immediately after removal of tumor, participants receive EAL-S with 10 L warmed 0.9% normal saline, delivered as 1 L lavage repeated 10 times over 15 minutes.
干预措施: Pancreatectomy (Procedure)
Arm II: Extensive Abdominal Lavage with Distilled Water (EAL-W)
Participants undergo pancreaticoduodenectomy. Immediately after removal of tumor, participants receive EAL-W with 10 L warmed distilled water, delivered as 1 L lavage repeated 10 times over 15 minutes.
干预措施: Pancreatectomy (Procedure)
Arm II: Extensive Abdominal Lavage with Distilled Water (EAL-W)
Participants undergo pancreaticoduodenectomy. Immediately after removal of tumor, participants receive EAL-W with 10 L warmed distilled water, delivered as 1 L lavage repeated 10 times over 15 minutes.
干预措施: Lavage (Other)
ARM III (NO EXTENSIVE LAVAGE)
Participants undergo pancreaticoduodenectomy with no extensive lavage after removal of tumor. Standard surgical irrigation, if performed at surgeon discretion, may occur as part of routine care.
干预措施: Pancreatectomy (Procedure)
结局指标
主要结局
Overall Survival
时间窗: Up to 27 months after resection
Will use a one-sided log-rank test to separately compare lavage (EAL-S or EAL-W) to no lavage with respect to OS. Assuming the study is not stopped at the interim analyses, the final comparison will be made with an alpha level of 0.02493. Distribution of OS will be estimated using the Kaplan-Meier method. Secondary analyses will use Cox regression to adjust the lavage/no lavage comparison for other baseline patient and/or characteristics known to be associated with OS.
次要结局
- Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0)(Up to 5 years after resection)
- Disease Free survival (DFS)(Up to 5 years after resection)
- Site of first recurrence (by site, distant vs local)(Up to 5 years after resection)