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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

Symptoms and General Pathology

Inflammation

Recurrence

Pancreatitis

Pancreatitis, Chronic

Cysts

Pancreatic Cyst

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Pancreatic Neuroendocrine Tumor

Patients randomized in this arm will undergo a robotic pancreaticoduodenectomy.

Patients randomized in this arm will undergo a routine open pancreaticoduodenectomy.

Patients in this arm will undergo a pancreaticoduodenectomy with robotic-assisted techonology.

Robotic pancreaticoduodenectomy

Patients in this arm will undergo an open pancreaticoduodenectomy which is the standard surgical approach.

Open pancreaticoduodenectomy

Jiabin JIN, PhD

Georgios Gemenetzis, MD

jiabin JIN, PhD

Baiyong Shen, PhD

This multicenter randomized trial aims to primarily assess and compare the functional recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and malignant lesions of the head of the pancreas.

The PORTAL trial is a Phase 3 multicenter non-inferiority randomized controlled trial that aims to address the question of feasibility and efficacy of the robotic minimally invasive approach in pancreaticoduodenectomy.

In the past 10 years there has been an increasing number of retrospective series from major centers for pancreatic surgery worldwide, that demonstrate similar and occasionally improved postoperative outcomes in patients who undergo a robotic pancreaticoduodenectomy (Whipple). The benefits of this minimally invasive approach appear to be decreased intraoperative estimated blood loss, lower postoperative pain levels and smaller length of hospital stay, whereas postoperative complications rates are comparable with the standard open approach.

This trial is conducted in multiple major centers for pancreatic surgery (open and robotic) in China and aims to address these questions in a prospective fashion. All eligible patients who present to these centers within the study period will be randomized in a 1:1 ratio to either of the two arms (open vs. robotic). Patients enrolled in the study will be blinded regarding the type of the procedure by application of identical wound dressings at the trocar sites and the open incision. Patients will be followed up closely and will be evaluated routinely for quality of life parameters for a period of at least 2 years postoperatively. Additionally, patients who undergo surgery in either arm for pancreatic adenocarcinoma will also be evaluated for time to adjuvant chemotherapy postoperatively, as well as recurrence and survival data.

Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors

Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors: A Multicenter Phase III Non-Inferiority Randomized Controlled Trial

Daily evaluation of patient postoperative course will take place by the nursing and medical staff and will be documented by the study coordinators. Postoperative criteria that need to be fulfilled independently to achieve functional recovery status are the following:

* Discontinuation of intravenous or subcutaneous analgesia and preservation of adequate control levels (pain score)
* Early ambulation and restoration of mobility to an independent level (or to preoperative level if previously impaired)
* Ability to maintain sufficient oral caloric intake as defined by institutional dietitian services, without intravenous fluid support
* No clinical signs of active abdominal infection affecting the patient's performance status: absence of fever, white cell count and C-reactive protein decreasing towards normalization. The patient can be in oral antibiotics.

The number of patients who are fit and well to initiate adjuvant chemotherapy at the 8-week mark after the operation will be documented and compared between the two arms

Comparison of estimated blood loss (in ml)

Comparison of operative time (in minutes, from first incision to skin closure)

Comparison of post-pancreatectomy morbidity between the two surgical approaches, that focus on:

* Pancreatic fistula
* Bile leak
* Chyle leak
* Delayed gastric emptying
* Surgical site infection
* Postoperative pancreatitis
* Postoperative hemorrhage
* Surgical site infections
* Other complications Additional documentation of re-intervention (radiological, endoscopic, or surgical) and re-admission rates, as well as postoperative hospital and ICU length of stay (time to discharge)

Comparison of mortality rates as a result of the pancreaticoduodenectomy in each arm

For assessment of postoperative quality of life (QoL) improvement, patients will be evaluated with the established EuqoQol EQ-5D-5L questionnaire, which is a self-reported assay focusing on five parameters: Pain/discomfort, anxiety/depression, usual activities, self-care, and mobility. Each of the five aforementioned parameters is scored from 0 to 5 (no issue, slight problem, moderate problem, severe problem, unable); patients also score independently their health status on a scale numbered from 0 to 100; 100 means the best health they can imagine, and 0 the worst.

Answered questionnaires will be collected on postoperative days 1, 3, 5, 7, and afterwards every week until day 30. QoL evaluation will terminate at Day 90.

In a sub-cohort of patients with pancreatic adenocarcinoma, the margin resection status (R) will be assessed and compared: R0 is defined as presence of tumor \>1mm from the resection margin, R1 as presence of tumor ≤1mm from the resection margin.

* Number of harvested lymph nodes
* Number of positive lymph nodes (infiltrated by tumor)
* Tumor size, degree of differentiation, perineural and lymphovascular invasion

In a sub-cohort of patients with pancreatic adenocarcinoma, the number of harvested and positive lymph nodes (infiltrated by tumor) will be assessed and compared between the two groups.

Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document disease recurrence, defined as the re-presentation of measurable tumor after resection.

Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document overall survival, defined as the time between date of operation and date of death.

Comparison of cost between the two groups, defined as the combination of intraoperative and postoperative costs, measured in US Dollars.

Enrolled patients in the study will be consented for peripheral blood draws in multiple time-points to assess the amount of circulating tumor DNA (ctDNA) and assess potential differences between the two groups in patients with pancreatic adenocarcinoma. The blood draws will occur: 1. immediately pre-operatively, 2. Postoperative days 2, 7, and 30.

Patients C-reactive protein (CRP, measured in ng/L) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.

Patients neutrophil-to-lymphocyte ratio (NLR, defined as the division of absolute neutrophil number to absolute lymphocyte number) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.

Patients Interleukin 6 (IL-6, measured in pg/mL) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.

Intuitive Surgical

Ruijin Hospital

Attending Surgeon, Pancreatic Disease Center

patients will be randomized to laparoscopic pancreatoduodenectomy group

Patients will be randomized to Open pancreatoduodenectomy

Open surgery

Laparoscopic surgery

Senthilnathan Palanisamy, MS, DNB

Palanivelu Chinnusamy, MS, MCh

Sandeep Sabnis, MS

The aim of this study is to compare the two surgical approaches namely laparoscopic pancreatoduodenectomy and open pancreatoduodenectomy for management of periampullary and pancreatic head cancers in terms of parameters like hospital stay, pathological radicality, complication rate, peri-operative and post operative outcomes.

Laparoscopic pancreatoduodenectomy (LPD) although technically difficult, requiring high degree of expertise, has shown equal efficacy in terms of complications, oncological safety \& overall outcome to that of open pancreatoduodenectomy (OPD) with advantages of minimally invasive surgery like decreased blood loss, reduced pain, shorter hospital stay \& early return to work.

Although current literature from various centres supports its use, the studies done so far are, case comparisons of either small sample of population or non-randomized trials. According to our knowledge, a randomized trial analyzing open versus laparoscopic pancreatoduodenectomy (PD) in terms of complications and outcome, has not been reported. With this current study we will try to address this issue.

This study is a prospective, randomized, parallel group, controlled trail comparing laparoscopic versus open pancreatoduodenectomy in relation to the hospital stay, peri-operative parameters, pathological radicality \& complications.

This is a single institute based trial, being conducted at GEM hospital and research center, Coimbatore, TN, India. The trial has been approved by the GEM Hospital ethical committee.

Through this trial we are planning to enroll patients having resectable periampullary and pancreatic head malignant lesion at diagnosis. After full assessment, optimization, approval of hospital tumor board with informed consent, those patients selected for surgical therapy with curative intention, will be randomized using computer generated random numbers either into Laparoscopic Pancreatoduodenectomy (LPD) group or Open Pancreatoduodenectomy (OPD) group.

The details of surgery, blood loss, operating time, conversion if any as well as details of postoperative events, hospital stay \& complications if any will be recorded in proforma. Protocols for adjuvant therapy according to pathological stages will be followed. These patients will be reviewed at 1, 3 and 6 months post-surgery.

The primary outcome will be hospital stay at time of discharge or death. The secondary outcomes will be Blood Loss, Operating Time, Complications and pathological radicality at discharge or death. The trial is expected to last for a duration of 2 years.

Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)

A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions

Two specimen arms will be compared on the basis of extent of pathological clearance like margin positivity rate, number of lymph nodes, average length of surgical margin

Pancreatic surgery specific complications will be accessed by International Study group for pancreatic surgery ( ISGPS) classification like post operative pancreatic fistula ( POPF). Other complications will be accessed by Clavien Dindo Classification system

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
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
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors	NCT04400357	Pancreatic Aden... Pancreatic Cyst... Pancreatic Endo... Chronic Pancrea... Cholangiocarcin... Ampullary Adeno... Duodenal Adenoc...	Robotic pancrea... Open pancreatic...	18 Years -	Ruijin Hospital
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors	NCT04400357	Pancreatic Aden... Pancreatic Cyst... Pancreatic Endo... Chronic Pancrea... Cholangiocarcin... Ampullary Adeno... Duodenal Adenoc...	Robotic pancrea... Open pancreatic...	18 Years -	Ruijin Hospital
Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)	NCT02081131	Adenocarcinoma ... Cholangio Carci... Duodenal Adenoc... Carcinoma of Am...	Open surgery Laparoscopic su...	30 Years - 70 Years	GEM Hospital & Research Center

Spots Global Cancer Trial Database for duodenal adenocarcinoma