Evaluation of A New Digestive Reconstruction Procedure Following Pancreatoduodenectomy

NCT01931449 | Unknown Phase 3 DMC

• 1 other identifier: NDR-2014-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Periampullary Carcinoma

Keywords

Pancreatoduodenectomy; Digestive Tract Reconstruction; Pancreas

Outcome Measures

Primary Outcomes (1)

• Incidence of Pancreatic Leakage

  up to 12 months

Secondary Outcomes (2)

• Life Quality Score

  up to 12 months

• Amylase Test of Abdominal Drainage Fluid

  up to 3 months

Other Outcomes (3)

• Anesthesia Score

  up to 12 months

• Length of Hospital Stay

  up to 12 months

• Re-surgery Rate

  up to 12 months

Study Arms (2)

Modified digestive reconstruction

EXPERIMENTAL

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

Routine pancreatoduodenectomy

ACTIVE COMPARATOR

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

Interventions

Modified method of digestive tract reconstruction PROCEDURE

Modified digestive reconstruction

Routine digestive tract reconstruction PROCEDURE

Routine pancreatoduodenectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Institution of Hepatobiliary Surgery, Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Huai-zhi Wang, M.D., Ph.D.

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

86-23-13996950719; whuaizhi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 29, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

CN (1)