Symptomatic Fluid Collection(s)
Conditions
Keywords
EUS-guided drainage, Percutaneous drainage, Endoscopic Ultrasound, Pancreas Surgery, Left pancreatectomy, Fluid collection
Brief summary
Fluid collections are a complication after pancreatic surgery. These fluid collections can be treated with two treatment options. One option is percutaneous drainage, where an external drainage tube is placed in the collection. The second option is endoscopic ultrasound-guided drainage (EUS) with a stent. Both options have similar results in previous clinical studies, but they have not been directly compared in a randomized clinical trial. The goal of this clinical trial is to compare percutaneous drainage with EUS-guided drainage. The main questions it aims to answer are: * Is EUS-guided drainage of symptomatic fluid collections non-inferior to percutaneous catheter drainage in terms of safety? * Is EUS-guided drainage superior in terms of 30-day quality of life, compared to percutaneous drainage? Researchers will compare EUS-guided drainage with percutaneous drainage to see if they are similar in safety outcomes and different in quality-of-life outcomes. Participants will: * Be randomized between percutaneous drainage and EUS-guided drainage. * Fill-out surveys and pain score when they start the study, and then after 1 week and 3 months. * Fill-out an extra pain score on day 1 and day 3. * Receive a phone call from the study team after 1 month, where they will be asked how they are doing. Together with the study team member they fill out the surveys that are taken after 1 month.
Interventions
DEVICEPlastic double pigtail stent
EUS-guided placement of plastic double pigtail stent in fluid collection.
DEVICEPercutaneous catheter
Percutaneous catheter with external collection bag is placed in the fluid collection
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Azienda Ospedaliera Universitaria Integrata Verona
Leiden University Medical Center
Radboud University Medical Center
St. Antonius Hospital
OLVG
University Medical Center Groningen
Maastricht University Medical Center
Medisch Spectrum Twente
Catharina Ziekenhuis Eindhoven
University Hospital Heidelberg
Erasmus Medical Center
IRCCS San Raffaele
Orlando Health, Inc.
Universitaire Ziekenhuizen KU Leuven
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years * Symptomatic fluid collection following a left pancreatectomy requiring drainage according to the treatment team. Indications for drainage exists of: 1. Symptoms of abdominal pain and/or persistent nausea. 2. Suspected infection/ sepsis * Drainage of the fluid collection is feasible both endoscopically and percutaneously as per the treating team. NB: Preferably this is also assessed and supported by the expert panel, but this is NOT mandatory given the potential urgent nature of the intervention. The investigators expect that multidisciplinary consultation with both intervening specialties precedes the feasibility assessment. * No contraindications for either procedure. If the contraindication can be overcome safely, such as ascites for which prior abdominal drainage is needed, the patient can still be included. * No prior drainage attempts of the fluid collection. * In case of a previously intraoperatively placed drain, it should have been removed 5 days prior to fluid collection development.
Exclusion criteria
* \<18 years * The fluid collection is not endoscopically or percutaneously feasible per the expert panel's judgement or the treatment team in acute situations, for example due to collection location too far from the gastrointestinal tract. * Prior drainage attempts of the fluid collection. * Received an indwelling percutaneous drain intraoperatively. Intraoperatively placed drains are only permitted when at least removed 5 days prior to development of the fluid collection. * Permanent incapacitation of research participant, prior to clinical deterioration caused by the pancreatic fluid collection, without expectation of improvement as per the treatment team. * Unable to obtain informed consent by either patient or their legal representative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of procedure (absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification) | 30-day | Non-inferiority analysis, absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification. The AGREE-grading ranges from Grade I to Grade V. The severity of the adverse event increases with the grade, grade I is non-exhaustive defined as deviation from the post-procedural course, grade V is defined by the death of a patient. |
| Co-primary: Quality of Life measured by the Physical Component Summary (PCS) from the 12-item Short Form Health Survey | 30-day | Superiority analysis, measured by the Physical Component Summary (PCS) from the 12-item short form health survey (SF-12). The SF-12 measures quality of life by physical (PCS) and mental health (MCS) scores, and is an abbreviated version of the 36-item short form health survey (SF-36). The PCS outcome ranges from 0-100. Scores of 0 indicate a poor health condition, while a score of 100 indicates good health. The PCS is described by 4 domains: bodily functioning, physical role limitation, pain and general perceived health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life by the Mental Component Score (MCS) from the 12-Item Short Form Health Survey (SF-12) | Baseline, day 7, day 30, day 90 | The SF-12 measures quality of life by physical (PCS) and mental health (MCS) scores, and is an abbreviated version of the 36-item short form health survey (SF-36). The MCS outcomes scores range from 0-100. Scores of 0 indicate a poor health condition, while a score of 100 indicates good health. The MCS is described by the following 4 domains: vitality, social functioning, emotional role limitation and mental health. |
| Quality of life by the Physical Component Summary (PCS) from the 12-Item Short Form Survey for quality of life (SF-12) | Baseline, day 7, day 30, day 90 | The SF-12 measures quality of life by physical (PCS) and mental health (MCS) scores, and is an abbreviated version of the 36-item short form health survey (SF-36). The PCS outcome ranges from 0-100. Scores of 0 indicate a poor health condition, while a score of 100 indicates good health. The PCS is described by 4 domains: bodily functioning, physical role limitation, pain and general perceived health. |
| Quality of life by the Numeric Rating Score (NRS) | Baseline, day 1, day 3, day 7, 30 days, 90 days | The NRS is an 11-point scale from 0 to 10, measuring pain. One number can be chosen to define the pain severity. 0 is defined as no pain, while 10 is the worst pain imagineable. |
| Quality of life by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) | Baseline, day 7, day 30, day 90 | The EQ-5D-5L questionnaire measures 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions have 5 levels ranging from no problems to extreme problems. Each answer comprises a number, which forms an index at the end of the survey which can be translated to the quality of life outcome. Lastly, a visual analogue scale (VAS) records self-reported health from 0-100, the lowest defined as "the worst health you can imagine", while the highest is defined as "the best health you can imagine". |
| Clinical success, relief of presenting symptoms or resolution of collection on imaging | 30 days | Presenting symptoms such as abdominal pain, persistent nausea, suspected infection/sepsis. Resolution on cross-sectional imaging. |
| Technical success index procedure | During index procedure | Defined as successful completion of the intended index procedure |
| Confirmed postoperative pancreatic fistula rate (POPF) | During 90-day follow-up | Following after amylase testing in collected fluid \>3 times normal upper serum limit. |
| Postoperative pancreatic fistula (POPF) classification | During 90-day follow-up | After confirmed POPF, following the International Study Group for Pancreatic Surgery (ISGPS) classification. The classification has 3 grades, the lowest is ungraded: the biochemical leak or fistula, which has no clinical consequence. Subsequent grade B and C entail a clinical relevant change in therapy and confirmed amylase testing, where grade C is most severe with unfavourable outcomes (1 or more of the following: re-operation, organ failure, mortality). |
| Timing of diagnosis postoperative pancreatic fistula (POPF) | During 90-day follow-up | Confirmed by amylase testing, in days after surgery |
| Reintervention rate | During 90-day follow-up | — |
| Hospital and ICU stay in days | During 90-day follow-up | — |
| Readmission rate | During 90-day follow-up | — |
| Timing of diagnosis fluid collection | Pre-procedure | Days after pancreatic surgery |
| Timing of indication for drainage fluid collection | Pre-procedure | Per the treatment team |
| Time to relief of initial symptoms | During 90-day follow-up | in days, such as: symptoms of abdominal pain and/or persistent nausea, suspected infection/sepsis |
| Prophylactic drain placement rate | Pre-procedure | — |
| Prophylactic drain removal time | Pre-procedure | In days after drain placement |
| Mortality | During 90-day follow-up | General and (un)related |
| Number of adverse events and serious adverse events following the Adverse Events in GI Endoscopy (AGREE) classification. | 30-day, 90-day | The AGREE-grading is from Grade I to Grade V. The severity of the adverse event increases with the grade, grade I is non-exhaustive defined as deviation from post-procedural course, grade V defined by the death of a patient. |
| Concurrence between local physicians and expert panel | Pre-procedural | In case of acute situations |
| Initial discharge location following hospital discharge | During 90-day follow-up | Discharge locations: home, home with home care, rehabilitation facility, nursing facility or hospice care. |
| New onset of organ failure rate | During 90-day follow-up | — |
| Attainability performing index procedure <24-48 hours after drainage indication | Index procedure | After the indication for drainage of the fluid collection has been set, it is measured that the index procedure is performed by the center within \<24-48 hours. |
| Presence of delayed gastric emptying (DGE) | Pre-intervention and through study completion, which is 3 months after index procedure | According to the International Study Group of Pancreatic Surgery (ISGPS) classification. The classification has 3 grades (A, B, C), increasing in severity. The grades address the nasogastric tube duration, toleration of solid oral intake, vomiting/gastric distension presence and the use of prokinetics. |
| Symptomatic recurrence rate | During 90-day follow-up | After relief of initial symptoms |
Countries
Netherlands
Contacts
CONTACTInge de Vries
Outcome results
None listed