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

  • STATUS
    Recruiting
  • End date
    Jan 12, 2023
  • participants needed
    667
  • sponsor
    Sidney Kimmel Cancer Center at Thomas Jefferson University
Updated on 23 February 2022
cancer
pancreaticoduodenectomy

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.

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) extensive intraoperative peritoneal saline lavage: 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) extensive intraoperative peritoneal distilled water lavage: 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.

Details
Condition Acinar Cell Carcinoma, Ampulla of Vater Adenocarcinoma, Cholangiocarcinoma, Duodenal Adenocarcinoma, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type, Periampullary Adenocarcinoma
Treatment Pancreatectomy, Lavage, Lavage
Clinical Study IdentifierNCT02757859
SponsorSidney Kimmel Cancer Center at Thomas Jefferson University
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy)
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
The subject is willing to consent to randomization of lavage vs. standard lavage

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
The subject is not willing to consent to EIPL-S lavage vs. EIPL-D lavage vs. standard
Subject with neoadjuvant chemotherapy or chemoradiation
Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors
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