NCT01695447

Brief Summary

The purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100 or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity, reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better than invagination.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

5.9 years

First QC Date

September 20, 2012

Last Update Submit

January 25, 2017

Conditions

Pancreatic NeoplasmsBiliary Tract Neoplasms

Outcome Measures

Primary Outcomes (1)

  • pancreatic fistula

    The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.

    From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days

Secondary Outcomes (4)

  • Mortality

    From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days

  • Morbidity

    From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days

  • Reoperation

    From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days

  • Hospital stay

    From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days

Study Arms (2)

duct-to-mucosa

EXPERIMENTAL

duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy

Procedure: duct-to-mucosaDevice: Internal stent

invagination

ACTIVE COMPARATOR

invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy

Procedure: invaginationDevice: Internal stent

Interventions

duct-to-mucosaPROCEDURE
duct-to-mucosa
invaginationPROCEDURE
invagination
Internal stentDEVICE

Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.

duct-to-mucosainvagination

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy
  • to 80 y/o
  • Operation-tolerated
  • Informed consent

You may not qualify if:

  • History of gastrointestinal operation
  • Pancreaticoduodenectomy is given up during operation
  • Pancreatic duct is difficult to locate
  • Patients require to exit from the study anytime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

  • Bai X, Zhang Q, Gao S, Lou J, Li G, Zhang Y, Ma T, Zhang Y, Xu Y, Liang T. Duct-to-Mucosa vs Invagination for Pancreaticojejunostomy after Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial from a Single Surgeon. J Am Coll Surg. 2016 Jan;222(1):10-8. doi: 10.1016/j.jamcollsurg.2015.10.003. Epub 2015 Oct 21.

    PMID: 26577499DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsBiliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract Diseases

Central Study Contacts

Xue-Li Bai, Ph.D.

CONTACT

+86 571 87783510shirleybai57@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 28, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

CN(1)