Trial · NCT02797067
Rectal Indomethacin to Prevent Post ESWL-pancreatitis
NCT02797067, Phase 4, Completed, Changhai Hospital; results first posted 2022-05-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rectal Indomethacin to Prevent Post ESWL-pancreatitis. Trials, record NCT02797067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02797067
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rectal Indomethacin to Prevent Post ESWL-pancreatitis
- NCT number
- NCT02797067
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,370 participants, actual
- Lead sponsor
- Changhai Hospital
- Conditions
- Pancreatitis
- Interventions
- indomethacin suppository, Glycerin Suppository
- First posted
- 2016-06-13
- Last updated
- 2022-05-26
- Results first posted
- 2022-05-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the Incidence of Post-ESWL Pancreatitis | up to 1 months | Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase\>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus. |
| Secondary | the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications | up to 1 months | Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ESWL levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion. Other post-ESWL complications including bleeding, infection, steinstrasse and perforation. Bleeding is related to clinical evidence，the level of hemoglobin ( measured at 24 hours after the procedure and at clinical discretion) and treatments. Infection is related to temperature and treatment. Steinstrasse is related to abdominal pain degree and the combination of other complications. Perforation is related to treatment. |
| Secondary | the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ） | up to 1 months | Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment. |
| Other | Relative Risks in the Subgroup of Potential Risk Factors for Post -ESWL Pancreatitis Will be Assessed by SPSS（Statistical Product and Service Solutions，a Statistical Software）. | up to 1 months | Potential risk factors including sex, steatorrhea, pancreas divisum, frequent attack of acute pancreatitis (≥ 1/year), diabetes, CBD（common bile duct） stenosis, alcohol consumption, multiple stones, position (the 30°-right supine position) and shock wave frequency ≥100/min.These will be assess to determine whether the treatment effect differ in these pre-specified factors. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | the Incidence of Post-ESWL Pancreatitis | up to 1 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications | up to 1 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ） | up to 1 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Relative Risks in the Subgroup of Potential Risk Factors for Post -ESWL Pancreatitis Will be Assessed by SPSS（Statistical Product and Service Solutions，a Statistical Software）. | up to 1 months |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| the Incidence of Post-ESWL Pancreatitis | Indomethacin | 60 | Participants | ||
| the Incidence of Post-ESWL Pancreatitis | Glycerin | 84 | Participants | ||
| the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications | Indomethacin | Infection | 5 | Participants | |
| the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications | Glycerin | Infection | 13 | Participants | |
| the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications | Indomethacin | Steinstrasse | 0 | Participants | |
| the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications | Glycerin | Steinstrasse | 1 | Participants | |
| the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications | Indomethacin | Perforation | 0 | Participants | |
| the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications | Glycerin | Perforation | 1 | Participants | |
| the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications | Indomethacin | Asymptomatic Hyperamylasemia | 189 | Participants | |
| the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications | Glycerin | Asymptomatic Hyperamylasemia | 197 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Indomethacin | 685 | |
| Overall Study | STARTED | Glycerin | 685 | |
| Overall Study | COMPLETED | Indomethacin | 685 | |
| Overall Study | COMPLETED | Glycerin | 685 | |
| Overall Study | NOT COMPLETED | Indomethacin | 0 | |
| Overall Study | NOT COMPLETED | Glycerin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Indomethacin | 0 | 685 |
| Total, all-cause mortality | Glycerin | 0 | 685 |
| Total, other adverse events | Indomethacin | 0 | 685 |
| Total, other adverse events | Glycerin | 0 | 685 |
| Total, serious adverse events | Indomethacin | 0 | 685 |
| Total, serious adverse events | Glycerin | 0 | 685 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Indomethacin vs Glycerin: the Incidence of Post-ESWL Pancreatitis | Trial comparisons |
| Indomethacin vs Glycerin: deaths from any cause | Trial comparisons |
| Indomethacin vs Glycerin: serious adverse events | Trial comparisons |
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/NCT02797067
GET https://conductscience.org/api/trials/v1/NCT02797067/results?page=2