Pancreatic Fistula Clinical Trial
— Early-DistOfficial title:
EARLY-DIST - Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy: a Randomized Controlled Trial
Verified date | January 2024 |
Source | IRCCS San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Main indications for distal pancreatectomy (DP) are pancreatic body and tail tumors including ductal adenocarcinoma, neuroendocrine tumors, and cystic neoplasms. Despite a less invasive operation with lower morbidity compared to pancreatic head surgery, DP is burdened by the occurrence of clinically-relevant postoperative pancreatic fistula (CR-POPF) in a significant proportion of patients. Drain fluid amylase (DFA) on POD 1 (postoperative day 1) > 2,000 U/L appears as the best performing threshold to predict the occurrence of CR-POPF after distal pancreatectomy. Although there is preliminary evidence that early drain removal in the subgroup of patients with DFA1 < 2,000 U/L may reduce POPF, no prospective study has yet evaluated the impact of an early drain removal strategy compared to standard management. The research question of this study is to evaluate to what extent early postoperative drain removal according to a validated DFA1 impact on clinically-relevant POPF rate after distal pancreatectomy in comparison to standard drain management. The primary hypothesis is that, early drain removal will result in a reduced proportion of patients experiencing grade B-C POPF according to ISGPS definition. The proposed study is a two-group, assessor-blind, randomized trial. Participants will be randomly assigned with a 1:1 ratio into one of two groups: (1) standard drain management or (2) early drain removal strategy. In this study adults (>18 years) patients with pancreatic body or tail diseases planned for distal pancreatectomy with or without splenectomy will be enrolled.The primary outcome is the POPF at 90 days after surgery, defined as grade B or C POPF according to ISGPS definition. Participants will be asked to complete some questionnaires in order to assess their general health status, and they will be evaluated at time of hospital admission, at 15 days, at 30 days after surgery (via telephone follow-up), and at 90 days after surgery (via telephone follow-up).
Status | Completed |
Enrollment | 150 |
Est. completion date | October 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults (>18 years) with pancreatic body or tail diseases planned for distal pancreatectomy with or without splenectomy Exclusion Criteria: - patient receiving an operation other than distal pancreatectomy (non-resective sx, total pancreatectomy) - concomitant celiac trunk resection (i.e. Appleby procedure) - concomitant multivisceral resection (i.e. colonic, gastric or liver resection) |
Country | Name | City | State |
---|---|---|---|
Italy | San Raffaele Hospital | Milan |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele |
Italy,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients (n, %) developing a clinically-relevant pancreatic fistula (CR-POPF) | The main (confirmatory) outcome of interest will be the occurrence of clinically-relevant pancreatic fistula at 90 days after surgery, defined as grade B or C POPF according to the 2016 ISGPS definition | 90 days after surgery | |
Secondary | Time to functional recovery (TFR) | TFR will be measured by subtracting the date of surgery from the date when participants achieves standardized criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilize and self-care and no evidence of untreated medical problems) | 7 days after surgery | |
Secondary | Comprehensive Complication Index (CCI) | The Comprehensive Complication Index is a validated measure summarizing the complete spectrum of complications occurred and their severity in a single score ranging from 0 to 100. Minimum value is 0 (no complications), maximum value is 100 (mortality). Higher scores mean a worse outcome. | 90 days after surgery | |
Secondary | Number of patients (n, %) developing a postoperative Surgical Site Infection (SSI) | SSIs is classified as superficial incisional, deep incisional or organ-space according to the definition by the Center for Disease Control and Prevention (CDC).
Superficial incisional SSI involves only skin and subcutaneous tissue of the incision. Deep incisional SSI involves deep soft tissues of the incision (for example, fascial and muscle layers). Organ/Space SSI involves any part of the body deeper than the fascial/muscle layers that is opened or manipulated during the operative procedure |
90 days after surgery | |
Secondary | Patient activity status - Duke Activity Status Index | Self-reported activity status will be measured using the Duke Activity Status Index (DASI), a brief questionnaire designed to assess physical function and predict exercise capacity (peak oxygen uptake). Participants are asked to respond whether they are able to perform 12 listed activities of various intensities (ambulation, household tasks, personal care and leisure activities). A specific score is given for each positive answer. The possible total score range from 0 to 58. 0 corresponds to no activity (worse outcome); 58 corresponds to performance of all activities (best outcome) | Pre-surgey, 15 days, 30 days, 90 days | |
Secondary | Generic health related quality of life - Patient Reported Outcome Measure Information System (PROMIS)-29+2 Profile version 2.1 | Generic heath related quality of life will be measured using the Patient Reported Outcome Measure Information System (PROMIS)-29+2 Profile v2.1 (PROPr), a questionnaire designed to measure self-reported physical, mental and social health and wellbeing. It contains 29 questions covering seven domains of health. All questions are ranked on a 5-point Likert Scale. Each domain (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities) is then scored on a scale from 4 to 20. For negative domains (Depression, Anxiety, Pain Interference, Fatigue, Sleep Disturbance), lower scores represent better outcomes, higher scores represent worse outcomes. For postive domains (Ability to Participate in Social Roles and Activities and Physical Function), lower scores represent worse outcomes, higher scores represent better outcomes. | Pre-surgery, 15 days, 30 days, 90 days | |
Secondary | Number of patients (n, %) requiring an unplanned hospital readmission after discharge | Unplanned hospital readmission is defined as the need for hospitalization for treatment of a postoperative complications within 90 days after surgery. | 90 days after surgery |
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