NCT01895790

Brief Summary

This research is being done to assess the effects of pancreatic duct stenting on relief of obstructive pain (pain due to outflow obstruction of main pancreatic duct) caused by pancreatic cancer.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 6, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

July 5, 2013

Last Update Submit

March 2, 2017

Conditions

Pancreatic Cancer

Keywords

Pancreatic CancerPancreatic DuctStentPancreatic Duct StentCancerPainObstructive PainPalliative

Outcome Measures

Primary Outcomes (2)

  • Abdominal pain severity score (Efficacy)

    The severity of abdominal pain assessed by visual Analog Scale (VAS) score ranging from 0 (no pain)-10 (the most severe pain). This will be measured at baseline (before procedure), and at 1 week, 4 weeks, 12 weeks, and 6 months after procedure

    6 months

  • Complications (Safety)

    Related complications within 30 days of endoscopic therapy will be recorded.

    6 months

Secondary Outcomes (10)

  • Pain relief

    6 months

  • Pain free duration

    6 months

  • Quality of life (QOL)

    6 months

  • Opioid dose

    6 months

  • Intervention time

    Intra-procedural

  • +5 more secondary outcomes

Study Arms (1)

Pancreatic Duct

EXPERIMENTAL

Consecutive adult patients (18-80 years of age) with cytopathologic diagnosis of unresectable pancreatic cancer complaining of pain due to pancreatic duct obstruction will receive a pancreatic duct stent.

Device: Pancreatic Duct Stent Placement

Interventions

Pancreatic Duct Stent PlacementDEVICE
Pancreatic Duct

Eligibility Criteria

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

You may qualify if:

  • Consecutive adult patients (18-80 years of age) with cytopathologic diagnosis of unresectable pancreatic cancer unresectable pancreatic cancer can be due 1) distant metastasis, 2) involvement of superior mesenteric artery or celiac artery, or 3) if the patient was unfit for surgery due to severe concomitant illness.
  • Significant biliary obstruction presenting for ERCP.
  • Significant obstructive-type abdominal pain despite use of opioid analgesics. Obstructive-pain is defined as abdominal pain that is intensified after food intake in the setting of dilated upstream pancreatic duct (\>4mm in diameter).
  • Ability to give informed consent.

You may not qualify if:

  • Unable to give informed consent
  • Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
  • Estimated life expectancy of 4 weeks or less
  • Malignant infiltration of the papilla as determined endoscopically or radiographically
  • Serum bilirubin level ≥ 2 mg/dl (to avoid a confounding variable with respect to the impact of PD stenting on the pain severity and the quality of life; concomitant biliary obstruction should be managed successfully before enrollment)
  • Acute gastrointestinal bleeding
  • Coagulopathy defined by prothrombin time \< 50% of control; PTT \> 50 sec, or INR \> 1.5), on chronic anticoagulation, or platelet count \<50,000
  • Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
  • Cirrhosis with portal hypertension, varices, and/or ascites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasmsPain

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mouen Khashab, MD

    Johns Hopkins Hospital Department of Gastroenterology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Official Title: Assistant Professor of Medicine; Director of Therapeutic Endoscopy

Study Record Dates

First Submitted

July 5, 2013

First Posted

July 11, 2013

Study Start

July 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 6, 2017

Record last verified: 2017-03

Locations

US(1)