Evaluation of A New Digestive Reconstruction Procedure Following Pancreatoduodenectomy

Phase 3

• Conditions: Pancreatic Cancer; Periampullary Carcinoma
• Interventions: Procedure: Modified method of digestive tract reconstruction; Procedure: Routine digestive tract reconstruction

• Registration Number: NCT01931449
• Lead Sponsor: Southwest Hospital, China

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.

Study Timeline

• Status Verified: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-26
• Last Update Submitted: 2013-08-26
• Study First Posted: 2013-08-29
• Last Update Posted: 2013-08-29
• Study Start: 2014-01
• Primary Completion: 2014-12
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified digestive reconstruction	Modified method of digestive tract 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.
Routine pancreatoduodenectomy	Routine digestive tract reconstruction	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Pancreatic Leakage	up to 12 months

Secondary Outcome Measures

Name	Time	Method
Life Quality Score	up to 12 months
Amylase Test of Abdominal Drainage Fluid	up to 3 months

Trial Locations

Locations (1)

Institution of Hepatobiliary Surgery, Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China