Evaluation of A New Digestive Reconstruction Procedure Following Pancreatoduodenectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer; Periampullary Carcinoma
• Intervention / Treatment: Procedure: Modified method of digestive tract reconstruction; Procedure: Routine digestive tract reconstruction

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Institution of Hepatobiliary Surgery, Southwest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified digestive reconstruction; Modified method of digestive tract reconstruction: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract with an independent intestinal loop and pancreas end.	Procedure: Modified method of digestive tract reconstruction
Active Comparator: Routine pancreatoduodenectomy; Routine digestive tract reconstruction: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes;Reconstruct the common bile duct-jejunum and pancreatic duct-jejunum respectively.	Procedure: Routine digestive tract reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Pancreatic Leakage	up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Life Quality Score	up to 12 months
Amylase Test of Abdominal Drainage Fluid	up to 3 months

Other Outcome Measures

Outcome Measure	Time Frame
Anesthesia Score	up to 12 months
Length of Hospital Stay	up to 12 months
Re-surgery Rate	up to 12 months

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): August 29, 2013
• Last Update Submitted That Met QC Criteria: August 26, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Pancreas; Pancreatoduodenectomy; Digestive Tract Reconstruction
• Other Study ID Numbers: NDR-2014-01