A Phase 3 interventional study of 19 French Blake Drain in Cyst of Pancreas, Pancreatectomy and Pancreas Neoplasm, sponsored by Case Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Case Comprehensive Cancer Center · Phase 3, Interventional, and Supportive care
Among 54 studies in Pancreatic Cyst with a site in United States — 20 open to participants now, 23 under way, 1 of them phase 3. Pancreatic Cyst · United States.
Among the 54 studies in Pancreatic Cyst with a site in United States, this one is the 5th largest by planned enrollment of the 22 interventional ones that give a count, is one of 3 that started in 2023, is one of 3 in phase 3, reaches primary completion later than 7 of the 22 other live ones, and was the 45th registered.
97 studies on the registry are indexed under Pancreatic Cyst; 37 are open to participants now.
This study's planned enrollment of 234 is above the median of 84 across 38 interventional studies indexed under Pancreatic Cyst.
Browse Pancreatic Cyst studies →20 of the 54 studies in Pancreatic Cyst with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 33 Pancreatic Cyst studies recruiting now, 25 (76%) set no upper age limit and 0 (0%) stop at 75 or younger; 2 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →54 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2023.
Median enrollment 53 across the 22 interventional studies, 300 across the 32 observational. Of the 26 that completed or were terminated, 5 (19%) have results posted.
4 of 54 have an industry lead sponsor. The 10 most frequent:
Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 61 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Case Comprehensive Cancer Center has 1 study filed under Pancreatic Cyst — fewer than ten, so there is no comparison to draw.
4 of the studies in Pancreatic Cyst with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05720338Phase 3Case Comprehensive Cancer CenterIs Intraperitoneal Drainage Necessary Following Distal Pancreatectomy? | 2026-12-31 |
| NCT04275557H. Lee Moffitt Cancer Center and Research InstituteUsing Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas | 2026-11 |
| NCT06564571Orlando Health, Inc.Artificial Intelligence in Endoscopic Ultrasound | 2026-12 |
| NCT05692596H. Lee Moffitt Cancer Center and Research InstituteThe Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics | 2027-07 |
Among the 54 studies in Pancreatic Cyst with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care.
Device: 19 French Blake Drain
No intraperitoneal drain will be placed in the participants, which omits the routine standard of care.
19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin
Also known as: Intraperitoneal drain
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF
Time frame: Within 90 days of surgery
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Grade C POPF
Time frame: Within 90 days of surgery
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes Readmission
Time frame: 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
Time frame: Within 90 days of surgery
Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF
Rates of drainage based off of the Grade B Postoperative pancreatic fistula
Time frame: 90-day post operative time point
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Global Health
Time frame: At day 14 postoperative
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Physical Function
Time frame: At day 14 postoperative
Quality of Life Score
Post-operative Quality of Life score using the original Drain Quality of Life scale
Time frame: At day 14 postoperative
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Global Health
Time frame: At day 90 postoperative
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Physical Function
Time frame: At day 90 postoperative
Quality of Life Score
Post-operative Quality of Life score using the original Drain Quality of Life scale
Time frame: At day 90 postoperative
Hospital Length of Stay
Measurement of the difference in Hospital Length-of-Stay based on intraperitoneal drainage after DP
Time frame: 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
Time frame: At day 90 postoperative
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Dec 2026, 44 months after the start.
How these figures are worked out, and which studies are left out of them.
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