Trial · NCT04027348
Palliative Management of Inoperable Malignant Bowel Obstruction
NCT04027348, Phase 2, Terminated, Roswell Park Cancer Institute; results first posted 2022-11-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Palliative Management of Inoperable Malignant Bowel Obstruction. Trials, record NCT04027348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04027348
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Palliative Management of Inoperable Malignant Bowel Obstruction
- NCT number
- NCT04027348
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
- Malignant Bowel Obstruction
- Interventions
- Dexamethasone, Metoclopramide, Octreotide
- First posted
- 2019-07-22
- Last updated
- 2022-11-29
- Results first posted
- 2022-11-29
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Obstruction Clearance | Within 7 days of starting protocol therapy | The primary efficacy endpoint is the proportion of eligible patients whose malignant bowel obstruction clears (de-obstruction) within 7 days of starting the protocol therapy. Patients meeting de-obstruction criteria within 7 days will be deemed treatment successes. De-obstruction is defined as: * Effective introduction of oral intake (yes/no) * Distinguished from small volumes of oral fluid that may be allowed with unresolved MBO * Tolerating oral liquid diet (day 1 of de-obstruction) that is able to be progressively more solid (oral or enteral) * Cessation of vomiting or ability for NGT or venting G tube to remain clamped without vomiting Rate of de-obstruction is defined as: \- From the date of study enrollment to the first observation of de-obstruction. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Obstruction Clearance | Within 7 days of starting protocol therapy | 2 Patients did not complete treatment and were not evaluated for de-obstruction (due to AEs). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Obstruction Clearance | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 10 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 15 | |
| Overall Study | COMPLETED | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 13 | |
| Overall Study | NOT COMPLETED | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 2 |
Source ClinicalTrials.gov
Adverse events30
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 | Sinus bradycardia | Cardiac disorders | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 2 | 15 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 1 | 15 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 2 | 15 | 2 |
| other | Dry mouth | Gastrointestinal disorders | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 1 | 15 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 2 | 15 | 2 |
| other | Small intestinal obstruction | Gastrointestinal disorders | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 5 | 15 | 6 |
| other | Vomiting | Gastrointestinal disorders | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 2 | 15 | 2 |
| other | Edema limbs | General disorders | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 3 | 15 | 3 |
| other | Fatigue | General disorders | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 1 | 15 | 1 |
| other | Pain | General disorders | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 2 | 15 | 2 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 13 | 15 |
| Total, other adverse events | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 11 | 15 |
| Total, serious adverse events | Treatment (Octreotide, Dexamethasone, Metoclopramide) | 6 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
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/NCT04027348
GET https://conductscience.org/api/trials/v1/NCT04027348/events?page=2