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Evaluation of A New Digestive Reconstruction Procedure Following Pancreatoduodenectomy

NCT ID: NCT01931449

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer Periampullary Carcinoma

Keywords

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Pancreatoduodenectomy Digestive Tract Reconstruction Pancreas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Modified method of digestive tract reconstruction

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Routine digestive tract reconstruction

Intervention Type PROCEDURE

Interventions

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Modified method of digestive tract reconstruction

Intervention Type PROCEDURE

Routine digestive tract reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Huai-zhi Wang

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huai-zhi Wang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, China

Locations

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Institution of Hepatobiliary Surgery, Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Central Contacts

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Huai-zhi Wang, M.D., Ph.D.

Role: CONTACT

Phone: 86-23-13996950719

Email: [email protected]

Facility Contacts

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Liang-yu Yin, M.D.

Role: primary

Other Identifiers

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NDR-2014-01

Identifier Type: -

Identifier Source: org_study_id