Acinar Cell CarcinomaNCT02757859
WASH Trial: Intraoperative Lavage as a Treatment for Pancreatic Cancer
A study testing Pancreatectomy and Lavage in people with Acinar Cell Carcinoma and Ampulla of Vater Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acinar Cell Carcinoma, Ampulla of Vater Adenocarcinoma, Cholangiocarcinoma
- What is being tested?
- Pancreatectomy and Lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 845 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2016to May 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled WAter or Saline at High Volumes for Resected Pancreatic Cancer
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:
Read more
- 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.
Read the detailed description
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:
- 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:
This is a prospective, randomized, participant-blinded clinical trial evaluating extensive abdominal lavage during pancreatic resection for pancreatic and periampullary malignancies.
Subjects are enrolled preoperatively and randomized prior to entering the operating room. Randomization is stratified by study site and use of neoadjuvant therapy. Subjects are randomized to one of three treatment arms:
Arm I (EAL-S): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy followed immediately after specimen removal by extensive abdominal lavage using 10 liters of warmed 0.9% normal saline administered as ten sequential 1-liter irrigations with aspiration.
Arm II (EAL-W): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy followed immediately after specimen removal by extensive abdominal lavage using 10 liters of warmed distilled water administered as ten sequential 1-liter irrigations with aspiration.
Arm III (Standard of Care/No Extensive Lavage): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy without protocol-directed extensive lavage following specimen removal.
The extensive lavage procedure is performed immediately after specimen removal and generally requires approximately 15 minutes.
A total of 845 subjects were enrolled. Subjects with suspected pancreatic or periampullary malignancy are enrolled preoperatively because definitive diagnosis cannot be established before resection. The primary efficacy analysis population consists of subjects with resected pancreatic cancer according to protocol-defined criteria.
For approximately the first 200 enrolled subjects, cytologic washings are obtained at predefined intraoperative time points (pre-dissection, post-resection, post-lavage, and specimen washing) for correlative analyses evaluating malignant cell clearance. Additional biologic studies may be performed using collected specimens.
Following completion of study treatment, subjects are followed initially at approximately 30 days after surgery and then every 3 months thereafter for survival, recurrence, postoperative outcomes, and adjuvant treatment information for up to 5 years following surgery or until death, whichever occurs first.
- Conditions
- Acinar Cell Carcinoma, Ampulla of Vater Adenocarcinoma, Cholangiocarcinoma, Duodenal Adenocarcinoma, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma
- Being tested
- Pancreatectomy, Lavage
- Medical subject headings
- Carcinoma, Acinar Cell, Cholangiocarcinoma, Pancreatic Intraductal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreatectomyProcedure or surgery
Also called Excision of the Pancreas, Pancreas Excision
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
LavageOther
Also called Irrigation, Wash
Receive EAL-S
PancreatectomyProcedure or surgery
Also called Excision of the Pancreas, Pancreas Excision
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
LavageOther
Also called Irrigation, Wash
Receive EAL-W
PancreatectomyProcedure or surgery
Also called Excision of the Pancreas, Pancreas Excision
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Extensive Abdominal Lavage with Saline (EAL-S) | Experimental | 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. Receives: Procedure: Pancreatectomy; Other: Lavage |
| Arm II: Extensive Abdominal Lavage with Distilled Water (EAL-W) | Experimental | 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. Receives: Procedure: Pancreatectomy; Other: Lavage |
| ARM III (NO EXTENSIVE LAVAGE) | Active comparator | 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. Receives: Procedure: Pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
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.
Measured: Up to 27 months after resection
Secondary outcomes (3)
Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0)
Will use chi-square or Fisher's exact test for dichotomous outcomes and Poisson regression for count outcomes.
Measured: Up to 5 years after resection
Disease Free survival (DFS)
Will use log-rank tests for time-to-event outcomes.
Measured: Up to 5 years after resection
Site of first recurrence (by site, distant vs local)
First recurrence site will be categorized by anatomic site and as local versus distant recurrence.
Measured: Up to 5 years after resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start27 Apr 2016
- Primary completionAug 2028 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acinar Cell CarcinomaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 845 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harish Lavu, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757859
- Sponsor's protocol ID
- 16D.083
- Other IDs
- JT 6902
- Status last verified
- May 2026
- First submitted
- 29 Apr 2016
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled WAter or Saline at High Volumes for Resected Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02757859
- Acronym / sponsor ID
- 16D.083
- Conditions
- Acinar Cell Carcinoma, Ampulla of Vater Adenocarcinoma, Cholangiocarcinoma, Duodenal Adenocarcinoma, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 845 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 2 May 2016 (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 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.
Detailed description
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:
- 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:
This is a prospective, randomized, participant-blinded clinical trial evaluating extensive abdominal lavage during pancreatic resection for pancreatic and periampullary malignancies.
Subjects are enrolled preoperatively and randomized prior to entering the operating room. Randomization is stratified by study site and use of neoadjuvant therapy. Subjects are randomized to one of three treatment arms:
Arm I (EAL-S): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy followed immediately after specimen removal by extensive abdominal lavage using 10 liters of warmed 0.9% normal saline administered as ten sequential 1-liter irrigations with aspiration.
Arm II (EAL-W): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy followed immediately after specimen removal by extensive abdominal lavage using 10 liters of warmed distilled water administered as ten sequential 1-liter irrigations with aspiration.
Arm III (Standard of Care/No Extensive Lavage): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy without protocol-directed extensive lavage following specimen removal.
The extensive lavage procedure is performed immediately after specimen removal and generally requires approximately 15 minutes.
A total of 845 subjects were enrolled. Subjects with suspected pancreatic or periampullary malignancy are enrolled preoperatively because definitive diagnosis cannot be established before resection. The primary efficacy analysis population consists of subjects with resected pancreatic cancer according to protocol-defined criteria.
For approximately the first 200 enrolled subjects, cytologic washings are obtained at predefined intraoperative time points (pre-dissection, post-resection, post-lavage, and specimen washing) for correlative analyses evaluating malignant cell clearance. Additional biologic studies may be performed using collected specimens.
Following completion of study treatment, subjects are followed initially at approximately 30 days after surgery and then every 3 months thereafter for survival, recurrence, postoperative outcomes, and adjuvant treatment information for up to 5 years following surgery or until death, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I: Extensive Abdominal Lavage with Saline (EAL-S) | Experimental | Procedure: Pancreatectomy, Other: LavageParticipants 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. |
| Arm II: Extensive Abdominal Lavage with Distilled Water (EAL-W) | Experimental | Procedure: Pancreatectomy, Other: LavageParticipants 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. |
| ARM III (NO EXTENSIVE LAVAGE) | Active comparator | Procedure: PancreatectomyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| PancreatectomyAlso: Excision of the Pancreas, Pancreas ExcisionUndergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy | Procedure or surgery | Arm I: Extensive Abdominal Lavage with Saline (EAL-S) |
| LavageAlso: Irrigation, WashReceive EAL-S | Other | Arm I: Extensive Abdominal Lavage with Saline (EAL-S) |
| PancreatectomyAlso: Excision of the Pancreas, Pancreas ExcisionUndergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy | Procedure or surgery | Arm II: Extensive Abdominal Lavage with Distilled Water (EAL-W) |
| LavageAlso: Irrigation, WashReceive EAL-W | Other | Arm II: Extensive Abdominal Lavage with Distilled Water (EAL-W) |
| PancreatectomyAlso: Excision of the Pancreas, Pancreas ExcisionUndergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy | Procedure or surgery | ARM III (NO EXTENSIVE LAVAGE) |
Primary outcome
Overall Survival
Time frame: 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.
3 secondary outcomes
Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0)
Time frame: Up to 5 years after resection
Disease Free survival (DFS)
Time frame: Up to 5 years after resection
Site of first recurrence (by site, distant vs local)
Time frame: Up to 5 years after resection
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 29 May 2026.
- Thomas Jefferson University HospitalLink provided by the sponsor.
Related trials for Acinar Cell Carcinoma
RecruitingPhase 2
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma
RecruitingPhase 1
First in Human Study of SNV1521 With a RAS Inhibitor for People With Advanced Pancreatic Cancer
Pancreatic Cancer, Pancreatic Acinar Carcinoma
Active, not recruitingPhase 1
Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery
Locally Advanced Pancreatic Adenocarcinoma, Pancreatic Acinar Cell Carcinoma
RecruitingPhase 1/2
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Advanced Cancer, Metastatic Cancer
Active, not recruitingPhase 2/3
The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer
Pancreatic Acinar Cell Carcinoma, Pancreatic Adenocarcinoma
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.
Harish Lavu, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatectomy and Lavage in people with Acinar Cell Carcinoma and Ampulla of Vater Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. 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 United States. 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?
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?
Overall Survival (time frame: Up to 27 months after resection). 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 29 May 2026.