Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Cholangiocarcinoma

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma, Acinar Cell

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Intraductal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Bile Duct Cancer

Acinic Cell Carcinoma

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

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

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

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

Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Pancreatectomy

Lavage

Harish Lavu, MD

Jordan Winter, MD

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.

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.

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

The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled Water or Saline at High Volumes for Resected Pancreatic Cancer

Will be modeled with repeated measures logistic regression using generalized estimating equations methods. Within this model, group differences in change from post-resection to post-lavage will be compared. McNemar's test for paired dichotomous data will be used to compare presence of cells at pre-dissection to post-resection.

Will use a one-sided log-rank test to separately compare lavage (EIPL-S or EIPL=D) 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.

Will use chi-square or Fisher's exact test for dichotomous outcomes and Poisson regression for count outcomes.

Will use log-rank tests for time-to-event outcomes.

Sidney Kimmel Cancer Center at Thomas Jefferson University

Colonic Neoplasms

Intestinal Obstruction

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

Patients with obstructive left-sided colonic cancer in wich treatment in one stage procedure is intraoperative colon lavage with primary anastomosis to avoid Hartamnn´s Procedure

intraoperative colon lavage with primary anastomosis

INTRODUCTION: There are several alternatives for one-stage emergency treatment of obstructive left-sided colonic cancer (OLCC): subtotal colectomy, intraoperative colon lavage (IOCL) with primary anastomosis, and the placement of a stent as a temporary measure prior to scheduled surgery. At present, it is not clear whether emergency perioperative lavage or the placement of a stent is the better technique. The hypothesis is that IOCL and primary anastomosis is equal safe or even safer than placement of a stent as a temporary measure prior to scheduled surgery, less length of stay and less cost.

OBJECTIVE: To establish which of these two techniques is more efficient in OLCC from the point of view of morbimortality, economic cost, and long-term survival.

MATERIAL AND METHODS:

Prospective, controlled, randomized study of patients diagnosed with OLCC. Patients were divided into two groups: group 1: stent and deferred surgery; group 2: emergency IOCL. A simple randomization system was used. The estimated sample size required per group was 21 patients. Demographic variables, risk prediction models, postoperative morbimortality, staging, complications due to the placement of stent, surgical time, clinical follow-up, health costs and follow-up of survival were recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery	NCT02757859	Acinar Cell Car... Ampulla of Vate... Cholangiocarcin... Duodenal Adenoc... Pancreatic Aden... Pancreatic Duct... Pancreatic Intr... Periampullary A...	Pancreatectomy Lavage Pancreatectomy Lavage Pancreatectomy	18 Years -	Thomas Jefferson University
Study of Intraoperative Colonic Irrigation Versus Stent Placement in Obstructive Left-Sided Colonic Cancer	NCT01196494	Colon Neoplasm Colorectal Surg... Intestinal Obst...	intraoperative ...	18 Years -	Corporacion Parc Tauli
High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery	NCT02757859	Acinar Cell Car... Ampulla of Vate... Cholangiocarcin... Duodenal Adenoc... Pancreatic Aden... Pancreatic Duct... Pancreatic Intr... Periampullary A...	Pancreatectomy Lavage Pancreatectomy Lavage Pancreatectomy	18 Years -	Thomas Jefferson University
Study of Intraoperative Colonic Irrigation Versus Stent Placement in Obstructive Left-Sided Colonic Cancer	NCT01196494	Colon Neoplasm Colorectal Surg... Intestinal Obst...	intraoperative ...	18 Years -	Corporacion Parc Tauli

Spots Global Cancer Trial Database for lavage

Every month we try and update this database with for lavage cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lavage

Every month we try and update this database with for lavage cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lavage cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.