Pancreatitis, ChronicNCT07202559
Indometacin With or Without Aggressive Intravenous Hydration to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy
A study testing Indometacin suppository, Lactated ringers solution and Normal Saline in people with Pancreatitis, Chronic and Pancreatitis, Acute, run by Changhai Hospital at 10 sites in China.
Trial summary
This study aims to determine whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after a Extracorporeal Shock Wave Lithotripsy (ESWL) than using indometacin alone. The study will involve patients who are scheduled to undergo ESWL for pancreatic stones. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatitis, Chronic, Pancreatitis, Acute, Pancreatic Duct Stones
- What is being tested?
- Indometacin suppository, Lactated ringers solution and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 10 sitesChina
- Study dates
- 13 Oct 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with painful chronic pancreatitis eligible for P-ESWL treatment
- Ages between 18-85 years
- Providing informed consent
Who cannot join
- Patients readmitted to the hospital for ESWL during the study period
- contraindications to ESWL
- Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure. For patients ≥ 70 years old, brain natriuretic peptide (BNP) and cardiac ultrasound would be performed before ESWL. Patients with BNP>100pg/ml or Ejection Fraction value<50% should be excluded
- Respiratory insufficiency (pO2 < 60 mmHg or saturation < 90% despite FiO2 of 30% or requiring mechanical ventilation). For patients ≥ 70 years old, pulmonary function tests would be performed before ESWL. Patients with Forced Expiratory Volume in the first second (FEV1) <70% are excluded
- Patients receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids in the 24 h before ESWL
- Hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <70 mmHg)
Show all 15Show fewer
- Hypo- or hypernatremia (serum Na+ levels < 130 or > 150 mmol/L)
- Severe liver disease (cirrhosis with ascites, liver abscess)
- receiving NSAIDs within 7 days
- Contraindications for rectal use of NSAIDs (renal dysfunction with serum creatinine >120 μmol/L, allergy, active gastrointestinal bleeding, ulcer disease, and NSAID use for other indications [other than cardioprotective aspirin])
- presence of coagulopathy or received anticoagulation therapy within 3 days
- acute pancreatitis within 3 days
- known active cardiovascular or cerebrovascular disease
- pregnant or breastfeeding women
- without a rectum (ie, status post-total proctocolectomy)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
The Second Affiliated Hospital of Baotou Medical College
Baotou
Tong Dang, +8613948823999
- Recruiting
Peking Union Medical College Hospital
Beijing
Ai-ming Yang
- Recruiting
Hangzhou First People's Hospital
Hangzhou
Xiao feng Zhang
- Recruiting
The Third Xiangya Hospital of Central South University
Hunan
Xiao-Yan Wang, +8613974889301
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou
Xun Li, +8613993138612
- Recruiting
Qilu Hospital of Shandong University
Shandong
Xiu-Li Zuo
- Recruiting
Changhai Hospital
Shanghai
Liang-Hao Hu, +8613817593520, lianghao-hu@hotmail.com
zhaoshen-li@hotmail.com
- Recruiting
Ruijin Hospital
Shanghai
Duo-Wu Zou, +8613901617608
- Recruiting
Shanghai Pudong New Area Gongli Hospital
Shanghai
Li-Ping Ling
- Not yet recruiting
Yunnan University Affiliated Hospital
Yunnan
Fubing Yu, +8615808875292
About this study
Official title: Aggressive Intravenous Hydration With Lactated Ringer's Solution Plus Rectal Indometacin Versus Rectal Indometacin Alone to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy: A Multicentre, Superiority, Randomised, Controlled Trial
This study aims to determine whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after a Extracorporeal Shock Wave Lithotripsy (ESWL) than using indometacin alone.
The study will involve patients who are scheduled to undergo ESWL for pancreatic stones. Participants will be randomly assigned to one of two groups: one will receive both the intravenous hydration and the rectal indometacin, while the other will receive only the rectal indometacin.
Read more
The trial will be conducted at multiple centers, ensuring a broad and diverse patient population.
The primary outcome of the study will be the incidence of pancreatitis after the ESWL procedure.
This study is important because it could lead to a better understanding of how to prevent pancreatitis after ESWL, potentially improving patient outcomes and reducing the risk of serious complications.
- Being tested
- Indometacin suppository, Lactated ringers solution, Normal Saline
- Medical subject headings
- Pancreatitis, Chronic, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indometacin suppositoryDrug
Administration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL
Lactated ringers solutionDrug
Intravenous 20 mL/kg Ringer's lactate solution within 60 min from the start of ESWL, directly followed by 3 mL/kg per h for 8 h.
Normal SalineDrug
Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h)
| Study group | Role | What they receive |
|---|---|---|
| Rectal indometacin alone | Active comparator | Participants in this arm will receive a rectal administration of 100mg indometacin 30 minutes prior to ESWL. This group will not undergo aggressive hydration and will instead receive restricted hydration measures. Receives: Drug: Indometacin suppository; Drug: Normal Saline |
| Aggressive hydration with rectal Indometacin | Experimental | Participants in this arm will also receive a rectal administration of 100mg indometacin 30 minutes before ESWL. In addition, they will undergo aggressive intravenous hydration using lactated Ringer's solution. Receives: Drug: Indometacin suppository; Drug: Lactated ringers solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-ESWL pancreatitis
Post-ESWL pancreatitis is defined according to the 2012 Atlanta criteria. A diagnosis of post-ESWL pancreatitis is made if two of three of the following criteria are met: pain consistent with pancreatitis; amylase or lipase of at least three times the upper normal limit within 24 h of the procedure; or characteristic findings on imaging.
Measured: 24 hours
Secondary outcomes (5)
Severity of pancreatitis
Stratified as mild, moderate, or severe, mainly on the basis of length of hospitalization and need for invasive treatment.
Measured: 1 month
Incidence of other post-ESWL complications
Including bleeding, infection, steinstrasse, and perforation.
Measured: 24 hours
Incidence of fluid overload
Including pulmonary or peripheral edema and congestive heart failure.
Measured: 24 hours
Transient adverse events related to ESWL
Transient adverse events were defined as transient injuries caused by shock waves that required no medical intervention and did not prolong hospitalisation, including asymptomatic hyperamylasaemia, haematuria, and acute gastrointestinal mucosal injury (eg, haematemesis, melena, or haem atochezia) caused by ESWL.
Asymptomatic hyper amylasaemia 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.
Measured: 24 hours
Length of hospitalisation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start13 Oct 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, ChronicStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, LanZhou University, First People's Hospital of Hangzhou, The Second Affiliated Hospital of Baotou Medical College, Shanghai Pudong New Area Gongli Hospital, Peking Union Medical College Hospital, Qilu Hospital of Shandong University, The Third Xiangya Hospital of Central South University, Affiliated Hospital of Yunnan University
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202559
- Sponsor's protocol ID
- PANDA
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggressive Intravenous Hydration With Lactated Ringer's Solution Plus Rectal Indometacin Versus Rectal Indometacin Alone to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy: A Multicentre, Superiority, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT07202559
- Acronym / sponsor ID
- PANDA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, LanZhou University, First People's Hospital of Hangzhou, The Second Affiliated Hospital of Baotou Medical College, Shanghai Pudong New Area Gongli Hospital, Peking Union Medical College Hospital, Qilu Hospital of Shandong University, The Third Xiangya Hospital of Central South University, Affiliated Hospital of Yunnan University
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after a Extracorporeal Shock Wave Lithotripsy (ESWL) than using indometacin alone.
The study will involve patients who are scheduled to undergo ESWL for pancreatic stones. Participants will be randomly assigned to one of two groups: one will receive both the intravenous hydration and the rectal indometacin, while the other will receive only the rectal indometacin.
The trial will be conducted at multiple centers, ensuring a broad and diverse patient population.
The primary outcome of the study will be the incidence of pancreatitis after the ESWL procedure.
This study is important because it could lead to a better understanding of how to prevent pancreatitis after ESWL, potentially improving patient outcomes and reducing the risk of serious complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal indometacin alone | Active comparator | Drug: Indometacin suppository, Drug: Normal SalineParticipants in this arm will receive a rectal administration of 100mg indometacin 30 minutes prior to ESWL. This group will not undergo aggressive hydration and will instead receive restricted hydration measures. |
| Aggressive hydration with rectal Indometacin | Experimental | Drug: Indometacin suppository, Drug: Lactated ringers solutionParticipants in this arm will also receive a rectal administration of 100mg indometacin 30 minutes before ESWL. In addition, they will undergo aggressive intravenous hydration using lactated Ringer's solution. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with painful chronic pancreatitis eligible for P-ESWL treatment
- Ages between 18-85 years
- Providing informed consent
Key exclusion criteria (15 listed)
- Patients readmitted to the hospital for ESWL during the study period
- contraindications to ESWL
- Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure. For patients ≥ 70 years old, brain natriuretic peptide (BNP) and cardiac ultrasound would be performed before ESWL. Patients with BNP>100pg/ml or Ejection Fraction value<50% should be excluded
- Respiratory insufficiency (pO2 < 60 mmHg or saturation < 90% despite FiO2 of 30% or requiring mechanical ventilation). For patients ≥ 70 years old, pulmonary function tests would be performed before ESWL. Patients with Forced Expiratory Volume in the first second (FEV1) <70% are excluded
- Patients receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids in the 24 h before ESWL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indometacin suppositoryAdministration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL | Drug | Aggressive hydration with rectal Indometacin, Rectal indometacin alone |
| Lactated ringers solutionIntravenous 20 mL/kg Ringer's lactate solution within 60 min from the start of ESWL, directly followed by 3 mL/kg per h for 8 h. | Drug | Aggressive hydration with rectal Indometacin |
| Normal SalineIntravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h) | Drug | Rectal indometacin alone |
Primary outcome
Incidence of post-ESWL pancreatitis
Time frame: 24 hours
Post-ESWL pancreatitis is defined according to the 2012 Atlanta criteria. A diagnosis of post-ESWL pancreatitis is made if two of three of the following criteria are met: pain consistent with pancreatitis; amylase or lipase of at least three times the upper normal limit within 24 h of the procedure; or characteristic findings on imaging.
5 secondary outcomes
Severity of pancreatitis
Time frame: 1 month
Incidence of other post-ESWL complications
Time frame: 24 hours
Incidence of fluid overload
Time frame: 24 hours
Transient adverse events related to ESWL
Time frame: 24 hours
Length of hospitalisation
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indometacin suppository, Lactated ringers solution and Normal Saline in people with Pancreatitis, Chronic and Pancreatitis, Acute, run by Changhai Hospital at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang-Hao Hu (+8613817593520, lianghao-hu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-ESWL pancreatitis (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.