Clinical trial NCT01931449: Evaluation of A New Digestive Reconstruction Procedure Following Pancreatoduodenectomy
Official title: Evaluation of a Modified Procedure of Digestive Tract Reconstruction Following Pancreatoduodenectomy: A Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Cancer
Periampullary Carcinoma
Keywords: Pancreatoduodenectomy
Digestive Tract Reconstruction
Pancreas
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the validity and safety of a modified operative procedure of digestive tract reconstruction following pancreatoduodenectomy which enables the pancreatic juice and bile to bypass at the pancreatointestinal anastomosis and merge at gastrointestinal anastomosis. It is anticipated that this procedure can decrease the risk of post-surgical pancreatic leakage and preserve the patients' digestive function as well.

Detailed description: Pancreatoduodenectomy (PD) is one of the most complicated surgeries in abdominal clinical practice. It is widely used in the treatment of pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis with intractable pain, pancreatic head mass which unable to rule out pancreatic cancer. PD was improved in many ways in the last 80 years and the post-surgical mortality has decreased under 5%. Since the resected region of PD is wide including gall bladder, billiary tract, duodenum, pancreas, stomach, jejunum and regional lymph nodes. It has a high prevalence of complications, of which pancreatic leakage is the most common and serious one with a prevalence rate of 5-25% and mortality rate 20-50%。 The objective of the present study is to evaluate a new surgical procedure used for the digestive tract reconstruction following PD. The new procedure enables the pancreatic juice and bile to bypass at the pancreatointestinal anastomosis and merge at gastrointestinal anastomosis which can decrease the risk of post-surgical pancreatic leakage and keep the digestive function of patients. A multicenter, randomized, controlled study is designed to observe the prevalence of pancreatic leakage, other post-surgical complications, hospital stay, medical costs, life quality and other indexes to evaluate the efficacy and safety of this procedure. It is anticipated that through the study, this new procedure can be systematically verified if it is an ideal procedure of digestive reconstruction following PD which can be promoted into wider use.

Eligibility criteria: Inclusion Criteria:

* Below 80 years old
* CT (Computed Tomography), CTA (Computed Tomographic Angiography), MRI (Magnetic Resonance Imaging) or ultrasonic test suggested pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis with intractable pain, pancreatic head mass which unable to rule out pancreatic cancer, with or without obstructive jaundice/chronic abdominal pain.

Exclusion Criteria:

* Liver Metastasis
* Metastasis in common bile duct and hepatic duct
* Extensive lymph node metastasis, metastasis at hepatic portal or above pancreas
* Pancreatic head or periampullary has tight adhesion with postcava or aorta
* Distant metastasis
* Poor physical condition to tolerate anesthesia and surgery (e.g. severe cardio-pulmonary diseases, blood coagulation disorders)

Primary outcomes:
measure: Incidence of Pancreatic Leakage
timeFrame: up to 12 months
Secondary outcomes:
measure: Life Quality Score
timeFrame: up to 12 months
measure: Amylase Test of Abdominal Drainage Fluid
timeFrame: up to 3 months
Other outcomes:
measure: Anesthesia Score
timeFrame: up to 12 months
measure: Length of Hospital Stay
timeFrame: up to 12 months
measure: Re-surgery Rate
timeFrame: up to 12 months
Locations:
city: Chongqing
country: China
facility: Institution of Hepatobiliary Surgery, Southwest Hospital
state: Chongqing
Study officials:
affiliation: Southwest Hospital, China
name: Huai-zhi Wang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: