Trial · NCT04276090
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma
NCT04276090, Not applicable, Terminated, Michael J Cavnar, MD; results first posted 2023-01-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma. Trials, record NCT04276090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04276090
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma
- NCT number
- NCT04276090
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 21 participants, actual
- Lead sponsor
- Michael J Cavnar, MD
- Conditions
- Bile Duct Neoplasms, Colorectal Neoplasms
- Interventions
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter., Hepatic artery infusion pump floxuridine and dexamethasone, Systemic chemotherapy for colorectal liver metastases, Systemic chemotherapy for intrahepatic cholangiocarcinoma
- First posted
- 2020-02-19
- Last updated
- 2023-07-25
- Results first posted
- 2023-01-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy | approximately 4 weeks | The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination. |
| Secondary | 30-day Postoperative Serious Adverse Events Related to Pump Implantation | 30 days | Tabulation of CTCAE serious adverse events attributed to pump implantation |
| Secondary | 30-day Catheter Malfunction Due to Tubing Disconnect | 30 days | Quantify the percent of patients with inability to meet primary outcome due to catheter disconnects. |
| Secondary | 30-day Catheter Malfunction Due to Inability to Access Pump | 30 days | Quantify the percent of patients with inability to meet primary outcome due to inability to access pump. |
| Secondary | Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function. | Approximately 4 weeks | Percentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function. |
| Secondary | Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool. | Immediate, determined at screening visit | Patients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated. |
| Secondary | Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments. | Approximately 6 months | Percent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated. |
| Secondary | Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments. | 6 months | The number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated. |
| Secondary | Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months. | 3 months | The percentage of patients who remain on pump chemotherapy at 3 months will be tabulated. |
| Secondary | Overall Response Rate at 6 Months | 6 months | RECIST v1.1 will be used to assess overall response rate at 6 months. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy | approximately 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 30-day Postoperative Serious Adverse Events Related to Pump Implantation | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 30-day Catheter Malfunction Due to Tubing Disconnect | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 30-day Catheter Malfunction Due to Inability to Access Pump | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function. | Approximately 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool. | Immediate, determined at screening visit | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments. | Approximately 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments. | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months. | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response Rate at 6 Months | 6 months | At the 6 month time point for this outcome there were only 14 evaluable participants for response rate due to attrition, death, or sub-RECIST threshold disease. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy | Colorectal Liver Metastases | 16 | Participants | ||
| Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy | Intrahepatic Cholangiocarcinoma | 4 | Participants | ||
| 30-day Postoperative Serious Adverse Events Related to Pump Implantation | Colorectal Liver Metastases | 1 | Participants | ||
| 30-day Postoperative Serious Adverse Events Related to Pump Implantation | Intrahepatic Cholangiocarcinoma | 0 | Participants | ||
| 30-day Catheter Malfunction Due to Tubing Disconnect | Colorectal Liver Metastases | 0 | Participants | ||
| 30-day Catheter Malfunction Due to Tubing Disconnect | Intrahepatic Cholangiocarcinoma | 0 | Participants | ||
| 30-day Catheter Malfunction Due to Inability to Access Pump | Colorectal Liver Metastases | 0 | Participants | ||
| 30-day Catheter Malfunction Due to Inability to Access Pump | Intrahepatic Cholangiocarcinoma | 0 | Participants | ||
| Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function. | Colorectal Liver Metastases | 0 | Participants | ||
| Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function. | Intrahepatic Cholangiocarcinoma | 0 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Colorectal Liver Metastases | 17 | |
| Overall Study | STARTED | Intrahepatic Cholangiocarcinoma | 4 | |
| Overall Study | COMPLETED | Colorectal Liver Metastases | 16 | |
| Overall Study | COMPLETED | Intrahepatic Cholangiocarcinoma | 4 | |
| Overall Study | NOT COMPLETED | Colorectal Liver Metastases | 1 | |
| Overall Study | NOT COMPLETED | Intrahepatic Cholangiocarcinoma | 0 |
Source ClinicalTrials.gov
Adverse events186
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Colorectal Liver Metastases | 15 | 17 | 15 |
| other | Anemia | Blood and lymphatic system disorders | Intrahepatic Cholangiocarcinoma | 3 | 4 | 3 |
| other | Other | Blood and lymphatic system disorders | Colorectal Liver Metastases | 1 | 17 | 1 |
| other | Other | Blood and lymphatic system disorders | Intrahepatic Cholangiocarcinoma | 0 | 4 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Colorectal Liver Metastases | 6 | 17 | 6 |
| other | Sinus tachycardia | Cardiac disorders | Intrahepatic Cholangiocarcinoma | 0 | 4 | 0 |
| other | Ventricular tachycardia | Cardiac disorders | Colorectal Liver Metastases | 4 | 17 | 4 |
| other | Ventricular tachycardia | Cardiac disorders | Intrahepatic Cholangiocarcinoma | 1 | 4 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Colorectal Liver Metastases | 1 | 17 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Intrahepatic Cholangiocarcinoma | 1 | 4 | 1 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Colorectal Liver Metastases | 3 | 17 |
| Total, all-cause mortality | Intrahepatic Cholangiocarcinoma | 2 | 4 |
| Total, other adverse events | Colorectal Liver Metastases | 17 | 17 |
| Total, other adverse events | Intrahepatic Cholangiocarcinoma | 4 | 4 |
| Total, serious adverse events | Colorectal Liver Metastases | 15 | 17 |
| Total, serious adverse events | Intrahepatic Cholangiocarcinoma | 2 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36410913 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Colorectal Liver Metastases vs Intrahepatic Cholangiocarcinoma: Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy | Trial comparisons |
| Colorectal Liver Metastases vs Intrahepatic Cholangiocarcinoma: Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments. | Trial comparisons |
| Colorectal Liver Metastases vs Intrahepatic Cholangiocarcinoma: 30-day Postoperative Serious Adverse Events Related to Pump Implantation | Trial comparisons |
| Colorectal Liver Metastases vs Intrahepatic Cholangiocarcinoma: Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool. | Trial comparisons |
| Colorectal Liver Metastases vs Intrahepatic Cholangiocarcinoma: Percent of Patients Who Are Downstaged and Undergo Surgery | Trial comparisons |
| Colorectal Liver Metastases vs Intrahepatic Cholangiocarcinoma: 30-day Catheter Malfunction Due to Inability to Access Pump | Trial comparisons |
| Colorectal Liver Metastases vs Intrahepatic Cholangiocarcinoma: Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months. | Trial comparisons |
| Colorectal Liver Metastases vs Intrahepatic Cholangiocarcinoma: Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function. | Trial comparisons |
| Colorectal Liver Metastases vs Intrahepatic Cholangiocarcinoma: deaths from any cause | Trial comparisons |
| Colorectal Liver Metastases vs Intrahepatic Cholangiocarcinoma: 30-day Catheter Malfunction Due to Tubing Disconnect | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04276090
GET https://conductscience.org/api/trials/v1/NCT04276090/results?page=2