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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status

Enrolling

Conditions

Acinar Cell Carcinoma

Ampulla of Vater Adenocarcinoma

Pancreatic Adenocarcinoma

Pancreatic Intraductal Papillary Mucinous Neoplasm

Cholangiocarcinoma

Pancreatic Ductal Adenocarcinoma

Periampullary Adenocarcinoma

Duodenal Adenocarcinoma

Treatments

Other: Lavage

Procedure: Pancreatectomy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02757859

16D.083

JT 6902 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

845 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

845 participants in 3 patient groups

Arm I (EIPL-S)

Active Comparator group

Description:

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

Treatment:

Procedure: Pancreatectomy

Other: Lavage

Procedure: Pancreatectomy

Other: Lavage

Arm II (EIPL-D)

Active Comparator group

Description:

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

Treatment:

Procedure: Pancreatectomy

Other: Lavage

Procedure: Pancreatectomy

Other: Lavage

ARM III (NO LAVAGE)

Sham Comparator group

Description:

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

Treatment:

Procedure: Pancreatectomy