Pancreaticoduodenectomy and Intraperitoneal Drainage

Table 1. Demographics and comorbid conditions of the participants in the study
N (%) or Mean (SD)	All (137)	Drain (68)	No Drain (69)	P
Sex
Male	75 (56)	37 (54)	38 (55)	0.938
Age, mean (SD)	63.2 (12.2)	62.1 (11.7)	64.3 (12.6)	0.289*
Coronary artery disease	28 (20)	12 (18)	16 (23)	0.421
Hypertension	79 (59)	35 (51)	44 (64)	0.145
Chronic obstructive pulmonary disease	7 (5)	3 (4)	4 (6)	1*
Diabetes mellitus	41 (30)	17 (25)	24 (35)	0.211
Renal insufficiency	7 (5)	4 (6)	3 (4)	0.718*
Chronic pancreatitis	15 (11)	7 (10)	8 (12)	0.808
Peripheral vascular disease	3 (2)	1 (1)	2 (3)	1*
Tobacco use
Current	27 (20)	13 (19)	14 (20)	0.736
Ever	52 (40)	24 (35)	28 (41)
Never	58 (42)	31 (46)	27 (39)
Body mass index (kg/m²)	27.7 (6.9)	27.8 (7.7)	27.6 (6.1)	0.869†
Albumin (mg/dL)	3.7 (0.6)	3.8 (0.5)	3.6 (0.7)	0.061†
Hemoglobin (g/dL)	12.6 (1.5)	12.7 (1.6)	12.4 (1.4)	0.304†
Creatinine (mg/dL)	0.9 (0.5)	0.95 (0.63)	0.89 (0.34)	0.502†
Neoadjuvant chemotherapy	14 (10)	8 (12)	6 (9)	0.553
Radiation (yes)	7 (5)	5 (7.4)	2 (2.9)	0.274*
ASA
1	2 (1)	2 (3)	0 (0)	0.265*
2	19 (14)	12 (18)	7 (10)
3	101 (74)	48 (71)	53 (77)
4	15 (11)	6 (9)	9 (13)

*Fisher exact test.
†T test; others: χ2 test.
ASA indicates American Society of Anesthesiologists; 1, a normal healthy patient; 2, a patient with mild systemic disease; 3, a patient with severe systemic disease; 4, a patient with severe systemic disease that is a constant threat to life.

Table 2. Operative data and subsequent interventions in the participants in the study
N (%) or Mean (SD)	All (137)	Drain (68)	No Drain (69)	P
Laparoscopic Whipple	11 (8)	5 (7)	6 (9)	0.773
Vascular resection	24 (18)	9 (13)	15 (22)	0.191
Additional procedure	21 (15)	10 (15)	11 (16)	0.841
Anastomotic technique	—	—	—	—
End-to-side, duct-to-mucosa	93 (68)	45 (66)	48 (70)	0.805
End-to-side, intussuscepted	23 (17)	13 (19)	10 (14)	—
End-to-end, intussuscepted	16 (12)	7 (10)	9 (13)
Pancreaticogastrostomy	5 (4)	3 (4)	2 (3)
Stented (internal) anastomosis	48 (35)	26 (38)	22 (32)	0.436
Soft pancreatic texture	69 (50)	34 (50)	35 (51)	0.932
Pancreatic duct size (mm)	3.9 (2)	3.9 (1.9)	4 (2)	0.895*
Operating time (min)	416 (154)	425 (151)	407 (157)	0.497*
Estimated blood loss (mL)	451 (347)	460 (352)	443 (344)	0.781*
RBC transfusion	10 (7)	4 (6)	6 (9)	0.745
Pathology	—	—	—	—
Pancreatic adenocarcinoma	67 (49)	34 (50)	33 (49)	0.871
Ampullary adenocarcinoma	17 (12)	7 (10)	10 (14)
Neuroendocrine carcinoma	11 (8)	4 (6)	7 (10)	—
Pancreatitis	11 (8)	6 (9)	5 (7)	—
Cystic lesion	8 (6)	4 (6)	4 (6)	—
Other	23(17)	13(19)	10(14)
Number of drains placed	—	—	—	—
1	N/A	23 (34)	N/A	N/A
2	N/A	45 (66)	N/A	N/A
POD last drain removed	N/A	7 (5–13)	N/A	N/A
Length of stay (days), median (interquartile range)	7 (6–11)	7 (6–9)	8 (7–14)	0.016†
Postoperative imaging (CT/MRI/US)	50 (37)	20 (29)	30 (44)	0.087
Postoperative percutaneous drain	22 (16)	6 (9)	16 (23)	0.022
POD percutaneous drain placed, median (interquartile range)	25 (13–46)	43 (15–81)	23 (13–39)	0.516†
Hospital readmission	28 (20)	16 (24)	12 (17)	0.373
Reoperation	8 (6)	2 (3)	6 (9)	0.274*

*T test.
†Wilcoxon rank sum test; others: χ ² test.
CT indicates computed tomography; MRI, magnetic resonance imaging; POD, postoperative day; RBC, red blood cell; US, ultrasound.

Table 3. Morbidity 30 and 60 days after pancreaticoduodenectomy
N (%) or Median (Interquartile Range)	30 d			60 d
N (%) or Median (Interquartile Range)	Drain (68)	No Drain (69)	P	Drain (68)	No Drain (69)	P
Any complication	50 (74)	52 (75)	0.8057	50 (74)	55 (80)	0.393
Any ≥ grade 2 complication (primary endpoint)	32 (47)	44 (64)	0.049	35 (52)	47 (68)	0.047
Any ≥grade 3 complication	19 (28)	28 (41)	0.119	21 (31)	28 (41)	0.236
Median number of complications per patient (any grade)	1 (0–2)	2 (1–3)	0.123	1 (0–2)	2 (1–4)	0.029*
Mean complication grade (all subjects)	1 (0–2)	2 (1–3)	0.059	2 (0–2)	2 (1–3)	0.027†
Mean complication grade (subjects with ≥ 1 Comp.)	2 (1–2)	2 (2–3)	0.007	2 (1–3)	2 (2–3)	0.017†
Complications with a significant difference
Gastroparesis	16 (24)	26 (38)	0.075	16 (24)	29 (42)	0.021
Intra-abdominal abscess	7 (10)	17 (25)	0.027*	8 (12)	18 (26)	0.033
Diarrhea (grade 1 excluded)	2 (3)	9 (13)	0.030	2 (3)	12 (17)	0.005
Abdominal fluid collection	1 (2)	8 (12)	0.033*	1 (2)	8 (12)	0.033*
Complications without a significant difference
Fistulas
Pancreatic fistula	21 (31)	14 (20)	0.155	21 (31)	14 (20)	0.155
Pancreatic fistula (grade A excluded)	7 (10)	14 (20)	0.104	8 (12)	14 (20)	0.174
Biliary fistula	3 (4)	1 (1)	0.366*	3 (4)	2 (3)	0.681*
Enteric fistula	—	1 (2)	1*	—	1(2)	1*
Chyle fistula	1 (2)	0.496*	1 (2)	—	0.495*
Infection and wound healing
Pneumonia	3 (4)	6 (9)	0.493*	3 (4)	7 (10)	0.325*
Wound infection	6 (9)	10 (15)	0.302	7 (10)	10 (15)	0.456
Wound seroma	3 (4)	5 (7)	0.718*	3 (4)	6 (9)	0.493*
Wound dehiscence	2 (3)	4 (6)	0.681*	2 (3)	5 (7)	0.441*
Urinary tract infection	3 (4)	3 (4)	1*	4 (6)	5 (7)	1*
Bacteremia/sepsis	2 (3)	4 (6)	0.681*	4 (6)	5 (7)	1*
Cardiovascular complications
Central venous catheter infection	2 (3)	1 (2)	0.620*	2 (3)	1 (2)	0.620*
Intra-abdominal hemorrhage	4 (6)	4 (6)	1*	4 (6)	6 (9)	0.745*
Gastrointestinal hemorrhage	2 (3)	6 (9)	0.274*	2 (3)	7 (10)	0.165*
Thromboembolic event	4 (6)	1 (2)	0.208*	5 (7)	1 (2)	0.115*
Arrhythmia	9 (13)	6 (9)	0.395	9 (13)	6 (9)	0.395
Myocardial infarction	1 (2)	—	0.496*	1 (2)	1 (2)	1*
Organ failure
Acute respiratory distress syndrome/respiratory failure	2 (3)	4 (6)	0.681*	2 (3)	6 (9)	0.274*
Hepatic failure	—	1 (2)	1*	1 (2)	1 (2)	1*
Renal failure/insufficiency	1 (2)	7 (10)	0.062*	3 (4)	9 (13)	0.074
Neurologic complications
Transient ischemic attack	1 (2)	—	0.496*	1 (2)	—	0.497*
Cerebral infarct/hemorrhage (stroke)	1 (2)	—	0.496*	1 (2)	—	0.497*
Altered mental status	1 (2)	5 (7)	0.208*	1 (2)	7 (10)	0.062*
Miscellaneous complications
Urinary retention	5 (7)	3 (4)	0.493*	5 (7)	4 (6)	0.745*
Diarrhea (all grades)	9 (13)	13 (19)	0.372	10 (15)	19 (28)	0.066
Other	5 (7)	5 (7)	1*	5 (7)	9 (13)	0.272

*Fisher exact test.
†Wilcoxon rank sum test; others: χ² test.

Table 4. Mortality 30, 60, and 90 days after pancreaticoduodenectomy
N (%)	All (137)	Drain (68)	No Drain (69)	P
30-d mortality	4 (3)	0 (0)	4 (6)	0.120
60-d mortality	7 (5)	1 (1)	6 (9)	0.115
90-d mortality	10 (7)	2 (3)	8 (12)	0.097

Fisher exact test for all.

Authors and Disclosures

George Van Buren II, MD*, Mark Bloomston, MD†, Steven J. Hughes, MD‡, Jordan Winter, MD§, Stephen W. Behrman, MD¶, Nicholas J. Zyromski, MD||, Charles Vollmer, MD**, Vic Velanovich, MD††, Taylor Riall, MD‡‡, Peter Muscarella, MD†, Jose Trevino, MD‡, Attila Nakeeb, MD||, C. Max Schmidt, MD||, Kevin Behrns, MD‡, E. Christopher Ellison, MD†, Omar Barakat, MD*, Kyle A. Perry, MD†, Jeffrey Drebin, MD†, Michael House, MD†, Sherif Abdel-Misih, MD†, Eric J. Silberfein, MD*, Steven Goldin, MD††, Kimberly Brown, MD‡‡, Somala Mohammed, MD*, Sally E. Hodges, BS*, Amy McElhany, MPH*, Mehdi Issazadeh, BS*, Eunji Jo, MS*, Qianxing Mo, PhD* and William E. Fisher, MD

*Baylor College of Medicine, The Elkins Pancreas Center, Michael E. DeBakey Department of Surgery, and The Dan L. Duncan Cancer Center, Houston, TX; †Department of Surgery, The Ohio State University, Columbus, OH; ‡Department of Surgery, University of Florida, Gainesville, FL; §Department of Surgery, Jefferson Medical College, Philadelphia, PA; ¶Department of Surgery, Baptist Memorial Hospital/The University of Tennessee Health Science Center, Memphis, TN; ||Department of Surgery, Indiana University, Indianapolis, IN; **Department of Surgery, University of Pennsylvania, Philadelphia, PA; ††Department of Surgery, University of South Florida, Tampa, FL; and ‡‡Department of Surgery, The University of Texas Medical Branch, Galveston, TX.

Disclosure
This trial was funded by the Rodrick A. MacDonald Foundation (11RD1004) and partially funded by the Cancer Prevention and Research Institute of Texas (CPRIT) grant (RP101353) and the Dan L. Duncan Cancer Center Support grant (CA125123). The authors declare no conflicts of interest.

Reprints
William E. Fisher,MD, The Elkins Pancreas Center,Michael E. DeBakey Department of Surgery, Baylor College of Medicine, 6620 Main St, Ste 1450, Houston, TX 77030. E-mail: wfisher@bcm.edu.