Clinical trialNACompleted
Pancreas Resection With and Without Drains
A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- September 2011
- Expected end
- 25 July 2017
- Enrollment
- 399 participants
- Sites
- 14
- Primary outcomes
- 60-day ≥ Grade II Complication Rate
- Sponsor
- Other
- Results posted
- 2020-08-31
- Last update
- 31 August 2020
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Brief summary public domain (ClinicalTrials.gov)
This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.
Detailed description public domain (ClinicalTrials.gov)
The rate of pancreatic fistula after pancreas resection is about 10% and surgeons have traditionally placed drains near the pancreatic anastomosis to control this potentially very serious complication. In recent years, advances in interventional radiology have allowed safe percutaneous drainage of intra-abdominal fluid collections. Some surgeons have abandoned the routine use of prophylactic drains placed at the time of pancreas resection and rely on percutaneous drainage for the minority of patients who develop a pancreatic fistula. Hypothesis: This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery. The primary endpoint to assess the severity of complications will be the number of patients with any ≥ Grade II complication. Severity of complications experienced will also be assessed by comparing the number of patients with, any ≥ Grade III complication, any serious adverse event (SAE), and the median complication severity grade of all complications. The frequency of complications will be assessed by comparing the number of patients with 1, 2, 3, 4, 5, or more than 5 complications of any severity grade. Objectives: Primary: Difference in 60-day ≥ Grade II complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage. Secondary: A. 60-day ≥ Grade III complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage. B. Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage. C. Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage. D. 60-day frequency of complications (any Grade) between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage. E. 60-day, and 90-day mortality rate comparison between patients who receive a pancreatetomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage. F. Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage. G. Length of stay (index admission and total within 60 days) comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage. H. Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage. I. Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
60-day ≥ Grade II Complication Rate [60 days]. Count Of Participants, Participants. No Drains (n=170): 72; Drains (n=174): 76. Analysis, No Drains vs Drains: p=0.804; Chi-squared; other.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
60-day ≥ Grade III Complication Rate [60 days]. Count Of Participants, Participants. No Drains (n=170): 44; Drains (n=174): 51.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Serious Adverse Event (SAE) Rate [60 days]. Count Of Participants, Participants. No Drains (n=170): 2; Drains (n=174): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Median Complication Severity Grade [60 days]. Median, severity grade (Inter-Quartile Range). All patients: No Drains (n=170): 1 (0 to 4); Drains (n=174): 1 (0 to 4). For just the patients with complications: No Drains (n=170): 4 (2 to 7); Drains (n=174): 3 (2 to 6).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
60-day Frequency of Complications [60 days]. Median, Complications per patient (Inter-Quartile Range). No Drains (n=170): 1 (0 to 2); Drains (n=174): 1 (0 to 2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
90-day Mortality Rate [90 days]. Count Of Participants, Participants. No Drains (n=170): 2; Drains (n=174): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Rate of Specific Complications [60 days]. Count Of Participants, Participants. Pancreatic_leak_fistula: No Drains (n=170): 20; Drains (n=174): 88. Postoperative_Abdominal_FluidCollection: No Drains (n=170): 38; Drains (n=174): 15. Biliary_leak: No Drains (n=170): 1; Drains (n=174): 1. Enteric_leak: No Drains (n=170): 2; Drains (n=174): 1. Lymph_Leak: No Drains (n=170): 1; Drains (n=174): 1. Diarrhea: No Drains (n=170): 17; Drains (n=174): 9. Gastroparesis_DelayedGastricEmptying: No Drains (n=170): 9; Drains (n=174): 10. SmallBowelObstruction: No Drains (n=170): 1; Drains (n=174): 3. Seroma: No Drains (n=170): 3; Drains (n=174): 3. Intra_abd_abscess: No Drains (n=170): 13; Drains (n=174): 15. Wound_Dehiscence: No Drains (n=170): 6; Drains (n=174): 4. Wound_Infection: No Drains (n=170): 5; Drains (n=174): 8. Fever: No Drains (n=170): 36; Drains (n=174): 30.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Length of Stay for the Index Admission [60 days]. Median, days (Inter-Quartile Range). No Drains (n=170): 5 (4 to 6); Drains (n=174): 5 (4 to 7).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Crude Cost [60 days].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Composite Quality of Life Scores [30 days and 60 days]. Median, score on a scale (Inter-Quartile Range). Physical well-being subscale: No Drains (n=170): 21 (14 to 27); Drains (n=174): 21 (16 to 24). Social/Family well-being subscale: No Drains (n=170): 21 (12 to 22); Drains (n=174): 21 (18 to 22). Emotional well-being subscale: No Drains (n=170): 20 (18 to 23); Drains (n=174): 20 (17 to 23). Functional well-being subscale: No Drains (n=170): 17 (12 to 22); Drains (n=174): 17 (12 to 21). Total FACT-G score: No Drains (n=170): 79 (63 to 88); Drains (n=174): 79 (66 to 87). FACT-Pa subscale: No Drains (n=170): 25 (21 to 28); Drains (n=174): 26 (21 to 29). Total FACT-Pa score: No Drains (n=170): 104 (84 to 114); Drains (n=174): 105 (87 to 116).