Cyst of PancreasPhase 3NCT05720338
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
A Phase 3 study testing 19 French Blake Drain in people with Cyst of Pancreas and Pancreatectomy, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cyst of Pancreas, Pancreatectomy, Pancreas Neoplasm
- What is being tested?
- 19 French Blake Drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 31 Jul 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
- Age ≥18 years
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients < 18 years old
- Patients who are pregnant
- Patients with a history of previous pancreatic surgery
- Patients with a history of prior gastric resection, gastric bypass or sleeve gastrectomy
- Patients with prior cystogastrostomy procedure
- Patients who have failed prior endoscopic intervention or ultrasound due to esophageal or other gastrointestinal stricture
Show all 11Show fewer
- Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operatively
- Patients undergoing concurrent resection of organs other than the pancreas or spleen or gallbladder
- Patients who undergo oversewing of the pancreatic transection margin
- Patients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drain
- Patients who are unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Robert Simon, MD
About this study
Official title: Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial
The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.
Read the detailed description
Pancreatic resections are commonly performed across the United States, yet still represent one of the most morbid abdominal operations in the country, with postoperative mortality as high as 7.7%. Distal pancreatectomy (DP) represents one of the most common approaches to pancreatic resection and is typically used for tumors of the pancreatic body or tail. This operation is known to have a high historic morbidity, with reports of overall morbidity between 12-52%. Common complications include intraabdominal abscess and surgical site infection. Postoperative pancreatic fistula (POPF) represents the most common complication following partial pancreatic resection, with rates reported with rates as high as 30% in multiple large retrospective studies. Multiple strategies to prevent postoperative pancreatic leak following distal pancreatectomy have been studied. One of the outstanding questions that remains is regarding the need for routine intraperitoneal drainage following DP, particularly since the advent of reinforced staple technology. This study aims to determine if intraperitoneal drainage is necessary following DP. This study will compare groups using a composite endpoint of complications.
- Conditions
- Cyst of Pancreas, Pancreatectomy, Pancreas Neoplasm
- Being tested
- 19 French Blake Drain
- Keywords
- Pancreatic neoplasm
- Medical subject headings
- Pancreatic Cyst, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19 French Blake DrainDevice
Also called Intraperitoneal drain
19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care. Receives: Device: 19 French Blake Drain |
| Omitting Standard of Care | No intervention | No intraperitoneal drain will be placed in the participants, which omits the routine standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF
Measured: Within 90 days of surgery
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Grade C POPF
Measured: Within 90 days of surgery
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes Readmission
Measured: Within 90 days of surgery
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Organ Space Surgical Site Infection
Measured: Within 90 days of surgery
Secondary outcomes (9)
Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF
Rates of drainage based off of the Grade B Postoperative pancreatic fistula
Measured: 90-day post operative time point
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Global Health
Measured: At day 14 postoperative
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Physical Function
Measured: At day 14 postoperative
Quality of Life Score
Post-operative Quality of Life score using the original Drain Quality of Life scale
Measured: At day 14 postoperative
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Global Health
Measured: At day 90 postoperative
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Physical Function
Measured: At day 90 postoperative
Quality of Life Score
Post-operative Quality of Life score using the original Drain Quality of Life scale
Measured: At day 90 postoperative
Hospital Length of Stay
Measurement of the difference in Hospital Length-of-Stay based on intraperitoneal drainage after DP
Measured: 90-day post operative time point
Cost analysis for overall healthcare costs
Cost analysis for overall healthcare costs associated with both methods of postoperative care
Measured: At day 90 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start13 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyst of PancreasStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Simon, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720338
- Sponsor's protocol ID
- CASE6222
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05720338
- Acronym / sponsor ID
- CASE6222
- Conditions
- Cyst of Pancreas, Pancreatectomy, Pancreas Neoplasm
- Keywords
- Pancreatic neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Feb 2023 (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.
The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.
Detailed description
Pancreatic resections are commonly performed across the United States, yet still represent one of the most morbid abdominal operations in the country, with postoperative mortality as high as 7.7%. Distal pancreatectomy (DP) represents one of the most common approaches to pancreatic resection and is typically used for tumors of the pancreatic body or tail. This operation is known to have a high historic morbidity, with reports of overall morbidity between 12-52%. Common complications include intraabdominal abscess and surgical site infection. Postoperative pancreatic fistula (POPF) represents the most common complication following partial pancreatic resection, with rates reported with rates as high as 30% in multiple large retrospective studies. Multiple strategies to prevent postoperative pancreatic leak following distal pancreatectomy have been studied. One of the outstanding questions that remains is regarding the need for routine intraperitoneal drainage following DP, particularly since the advent of reinforced staple technology. This study aims to determine if intraperitoneal drainage is necessary following DP. This study will compare groups using a composite endpoint of complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Device: 19 French Blake DrainIntraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care. |
| Omitting Standard of Care | No intervention | –No intraperitoneal drain will be placed in the participants, which omits the routine standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
- Age ≥18 years
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (11 listed)
- Patients < 18 years old
- Patients who are pregnant
- Patients with a history of previous pancreatic surgery
- Patients with a history of prior gastric resection, gastric bypass or sleeve gastrectomy
- Patients with prior cystogastrostomy procedure
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 |
|---|---|---|
| 19 French Blake DrainAlso: Intraperitoneal drain19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin | Device | Standard of care |
Primary outcome
Composite endpoint comparison
Time frame: Within 90 days of surgery
Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF
Composite endpoint comparison
Time frame: Within 90 days of surgery
Comparison between groups using a composite endpoint of complications that includes presence of Grade C POPF
Composite endpoint comparison
Time frame: Within 90 days of surgery
Comparison between groups using a composite endpoint of complications that includes Readmission
Composite endpoint comparison
Time frame: Within 90 days of surgery
Comparison between groups using a composite endpoint of complications that includes presence of Organ Space Surgical Site Infection
9 secondary outcomes
Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF
Time frame: 90-day post operative time point
Quality of Life Score
Time frame: At day 14 postoperative
Quality of Life Score
Time frame: At day 14 postoperative
Quality of Life Score
Time frame: At day 14 postoperative
Quality of Life Score
Time frame: At day 90 postoperative
Quality of Life Score
Time frame: At day 90 postoperative
Quality of Life Score
Time frame: At day 90 postoperative
Hospital Length of Stay
Time frame: 90-day post operative time point
Cost analysis for overall healthcare costs
Time frame: At day 90 postoperative
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Robert Simon, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 19 French Blake Drain in people with Cyst of Pancreas and Pancreatectomy, run by Case Comprehensive Cancer Center at 1 site in United States.
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 11 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Robert Simon, MD (1-866-223-8100, TaussigResearch@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint comparison (time frame: Within 90 days of surgery). The study lists 4 primary outcomes in all. 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 15 Sep 2026.