Neoplasms

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Biliary Tract Diseases

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Bile Duct Diseases

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Bile Duct Cancer

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Liver Extracts

Care coordinator facilitates the assessment and treatment of cancer-related symptoms

Upon evaluation of symptoms the patient will be referred for further assessment or treatment if indicated

Collaborative care intervention to manage cancer-related symptoms

Collaborative Care

Enhanced usual Care

Jennifer L Steel, Ph.D.

The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.

The study is a collaborative care intervention designed to reduce pain, fatigue, and depressive symptoms and improve overall health related quality of life.

Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms

Phase III Randomized Controlled Trial of a Collaborative Care Intervention to Manage Cancer Related Symptoms in Patients Diagnosed With Hepatobiliary Carcinoma

Center for Epidemiological Studies-Depression scale

Functional Assessment of Cancer Therapy-Fatigue

National Cancer Institute (NCI)

University of Pittsburgh

Director, Center for Excellence in Behavioral Medicine

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

Gemcitabine

Cisplatin

SIRT Yttrium-90

Stephen L Chan, FRCP

The current standard treatment of inoperable intrahepatic cholangiocarcinoma (bile duct cancer in the liver) is chemotherapy, which is of limited efficacy. The use of selective internal radiotherapy treatment (SIRT-Y90) is proven efficacious in patients with intra-heptic tumor. Previous experience with SIRT is safe in patients with intrahepatic cholangiocarcinoma. This study aims to study the benefits of sequential administration of SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic cholangiocarcinoma.

Treatment for Bile Duct Cancer in the Liver

Selective Internal Radiation Therapy With Yttrium-90 Resin Microspheres Followed by Gemcitabine Plus Cisplatin for Intra-hepatic Cholangiocarcinoma: A Phase II Study

Chinese University of Hong Kong

Comprehensive Clinical Trial Unit

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

GEM Hospital & Research Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms	NCT01640522	Hepatocellular ... Primary Liver C... Bile Duct Cance... Pancreatic Canc... Gallbladder Can... Colorectal Carc... Liver Metastase...	Collaborative C... Enhanced usual ...	18 Years -	University of Pittsburgh
Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms	NCT01640522	Hepatocellular ... Primary Liver C... Bile Duct Cance... Pancreatic Canc... Gallbladder Can... Colorectal Carc... Liver Metastase...	Collaborative C... Enhanced usual ...	18 Years -	University of Pittsburgh
Treatment for Bile Duct Cancer in the Liver	NCT02167711	Cholangio Carci...	SIRT Yttrium-90	18 Years -	Chinese University of Hong Kong
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
Treatment for Bile Duct Cancer in the Liver	NCT02167711	Cholangio Carci...	SIRT Yttrium-90	18 Years -	Chinese University of Hong Kong

Spots Global Cancer Trial Database for cholangio carcinoma