Evaluation of A New Digestive Reconstruction Procedure Following Pancreatoduodenectomy

Pancreatic Cancer Clinical Trial

Official title:

Evaluation of a Modified Procedure of Digestive Tract Reconstruction Following Pancreatoduodenectomy: A Multicenter Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01931449
• Other study ID #: NDR-2014-01
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 21, 2013
• Last updated: August 26, 2013
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2013
• Source: Southwest Hospital, China
• Contact: Huai-zhi Wang, M.D., Ph.D.
• Phone: 86-23-13996950719
• Email: whuaizhi[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Periampullary Carcinoma

Intervention

Procedure:
• Modified method of digestive tract reconstruction

• Routine digestive tract reconstruction

Locations

Country	Name	City	State
China	Institution of Hepatobiliary Surgery, Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anesthesia Score		up to 12 months	Yes
Other	Length of Hospital Stay		up to 12 months	Yes
Other	Re-surgery Rate		up to 12 months	Yes
Primary	Incidence of Pancreatic Leakage		up to 12 months	Yes
Secondary	Life Quality Score		up to 12 months	No
Secondary	Amylase Test of Abdominal Drainage Fluid		up to 3 months	Yes