CClinicalTrials.gg
Status unknownNCT01634971EDIDPDUpdated Feb 17, 2016

External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent After Pancreaticoduodenectomy (EDIDPD)

A Phase 2 interventional study of Internal Drainage of Pancreatic Duct after pancreatomy in Postoperative Fistula and Complications of Surgical and Medical Care: General Terms, sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-02-17.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Postoperative pancreatic fistula (POPF) and other surgical complications are common after pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct is important and a stent is usually placed in the operation, but it is still controversial whether the stent drainage is internal or external.

Read the detailed description

The current study is to compare the rate of Postoperative pancreatic fistula(POPF) and other surgical complications after pancreatoduodenectomy (PD).

02

Conditions studied

  • Postoperative Fistula
  • Complications of Surgical and Medical Care: General Terms

Browse trials for

Keywords

  • Postoperative pancreatic fistula(POPF);
  • Postpancreatectomy hemorrhage(PPH);
  • Delayed gastric emptying (DGE);
  • Bile leakage after pancreatic surgery;
  • Anastomotic leakage
03

In context

Fistula

731 studies on the registry are indexed under Fistula; 103 are open to participants now.

This study's planned enrollment of 120 is above the median of 60 across 484 interventional studies indexed under Fistula.

Browse Fistula studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age more than 18 years.
  • Received pancreatoduodenectomy.
  • Informed consent has been signed.

Exclusion criteria

Exclusion Criteria:

  • Age less than 18 years
  • Emergency surgery
  • Past history of pancreatic surgery.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • No intervention
    External Drainage of pancreatic duct

    External Drainage of pancreatic duct was used in PD.

  • Experimental
    Internal Drainage of Pancreatic Duct

    the Intervention name is: Internal Drainage of Pancreatic Duct after pancreatomy, a stent was placed in the pancreatic duct, external drainage of the stent is defined as control group(the stent will be tans-abdomen and as a drainage of pancreatic fluid), and internal drainage of the stent is defined as interventional(or experimental) group, with the stent very short(2cm) and placed in jejunum.

    Procedure: Internal Drainage of Pancreatic Duct after pancreatomy

Interventions

  • ProcedureInternal Drainage of Pancreatic Duct after pancreatomy

    the Intervention name is: Internal Drainage of Pancreatic Duct after pancreatomy, a stent was placed in the pancreatic duct, external drainage of the stent is defined as control group(the stent will be tans-abdomen and as a drainage of pancreatic fluid), and internal drainage of the stent is defined as interventional(or experimental) group, with the stent very short(2cm) and placed in jejunum.

06

What researchers measure

Primary outcomes

  1. the rate of Postoperative pancreatic fistula within 2 weeks after operation

    Postoperative pancreatic fistula (POPF) is defined as a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity.

    Time frame: within 2 weeks after operation

Secondary outcomes

  1. the rate of postoperative Surgical Complications

    the rate of Postpancreatectomy hemorrhage(PPH);Delayed gastric emptying (DGE); Bile leakage after pancreatic surgery;Anastomotic leakage

    Time frame: 2 weeks after operation

07

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University Cancer Institute and Hospital
    Tianjin, Tianjin 300060, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01634971
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Responsible party
Sponsor
First posted
Jul 6, 2012
Start date
May 2012
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Feb 17, 2016

Study contacts

Qiang WU, MD. Ph.D.
Contact
wuqiangtianjin@hotmail.com
18622221080
Qiang WU, MD. Ph.D.
study chair · Tianjin Medical University Cancer Institute and Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion