High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery

NCT ID: NCT02757859

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 845 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-27
• Study Completion Date: 2026-04-27

Brief Summary

This randomized clinical trial studies how well high volume washing of the abdomen works in increasing survival after surgery in patients with pancreatic cancer that can be removed by surgery. High volume washings may remove free floating cancers present after surgery and help prolong survival in patients with pancreatic cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. Overall survival (OS) (18 to 27 months after resection).

SECONDARY OBJECTIVES:

I. Disease free survival (DFS). II. Complication rate. III. Site of first-recurrence (by site, and distant vs. local). IV. Clearance of malignant cells pre vs. post-lavage.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I (EIPL-S): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal saline (EIPL-S) lavage 10 times over 15 minutes.

ARM II (EIPL-D): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal distilled water (EIPL-D) lavage 10 times over 15 minutes.

ARM III (NO LAVAGE): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.

After completion of study treatment, patients are followed up every 3 months.

Conditions

Acinar Cell Carcinoma; Ampulla of Vater Adenocarcinoma; Cholangiocarcinoma; Duodenal Adenocarcinoma; Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Intraductal Papillary Mucinous Neoplasm; Periampullary Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm I (EIPL-S)

Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-S lavage 10 times over 15 minutes.

Group Type: ACTIVE_COMPARATOR

Pancreatectomy

Intervention Type: PROCEDURE

Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Lavage

Intervention Type: OTHER

Receive EIPL-S

Arm II (EIPL-D)

Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-D lavage 10 times over 15 minutes.

Group Type: ACTIVE_COMPARATOR

Pancreatectomy

Intervention Type: PROCEDURE

Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Lavage

Intervention Type: OTHER

Receive EIPL-D

ARM III (NO LAVAGE)

Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.

Group Type: SHAM_COMPARATOR

Pancreatectomy

Intervention Type: PROCEDURE

Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Interventions

Pancreatectomy

Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Intervention Type: PROCEDURE

Lavage

Receive EIPL-S

Intervention Type: OTHER

Pancreatectomy

Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Intervention Type: PROCEDURE

Lavage

Receive EIPL-D

Intervention Type: OTHER

Pancreatectomy

Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Intervention Type: PROCEDURE

Other Intervention Names

Excision of the Pancreas; Pancreas Excision; Irrigation; Wash; Excision of the Pancreas; Pancreas Excision; Irrigation; Wash; Excision of the Pancreas; Pancreas Excision

Eligibility Criteria

Inclusion Criteria

• The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, 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. standard EAL-W vs. no extensive lavage. (SOC)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harish Lavu, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Case Western Reserve University

Cleveland, Ohio, United States

Site Status: RECRUITING

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Harish Lavu, MD

Role: CONTACT

215-955-9402

Facility Contacts

Jordan Winter, MD

Role: primary

jordan.winter@UHhospitals.org

216-844-5777

Harish Lavu, MD

Role: primary

harish.lavu@jefferson.edu

215-955-9402

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 6902

Identifier Type: OTHER

Identifier Source: secondary_id

16D.083

Identifier Type: -

Identifier Source: org_study_id