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Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy

Randomised Prospective Study of Clinical Outcomes After Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy After Pancreatoduodenectomy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00679952
Enrollment
168
Registered
2008-05-19
Start date
2007-03-31
Completion date
2010-03-31
Last updated
2014-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Fistula

Keywords

Pancreatic fistula, Pancreatic duct stent, Closed suction drainage

Brief summary

Pancreaticojejunal anastomosis leakage is a major complication after pancreatoduodenectomy and various technical methods have been examined to improve the situation.However, none of methods have been successful at improving results according to the findings of prospective randomized studies. We propose that active drainage of pancreatic juice using suction drainage might maximize the advantage of a stent and finally reduce pancreaticojejunal anastomosis leakage.

Detailed description

Pancreaticojejunal anastomosis leakage is a major complication after pancreatoduodenectomy and various technical methods have been examined to improve the situation, e.g., pancreatic duct occlusion, anastomosis reinforcement with fibrin glue, placement of an internal stent, and pancreaticogastrostomy. However, none of these methods have been successful at improving results according to the findings of prospective randomized studies. Some retrospective studies have reported a low pancreatic fistula rate when a catheter is inserted into the pancreatic duct to externally drain pancreatic juice. Furthermore, a recent prospective randomized trial showed that external drainage of the pancreatic duct decreased the rate of pancreatic fistula formation indicating that diverting pancreatic juice from an anastomosis can theoretically reduce the incidence of pancreaticojejunostomy anastomotic leakage. We propose that active drainage of pancreatic juice using suction drainage might maximize the advantage of a stent and finally reduce pancreaticojejunal anastomosis leakage. We will enroll all patients who underwent duct-to-mucosa pancreaticojejunostomy reconstruction after pancreatoduodenectomy, and randomly allocate them to two groups of closed suction drainage group (CD group) and natural drainage group (ND group) just after operations. Preoperative demographic and clinical data, and surgical procedure, pathologic diagnosis, postoperative course and complications details were collected prospectively. The primary study endpoints were; pancreatic fistula rates, severity of pancreatic fistulas, postoperative complications, postoperative length of hospital stay, and hospital mortality rate. Pancreatic fistula was defined as any measurable drainage from an operatively placed drain (or a subsequently placed percutaneous drain) on or after postoperative day 3, with an amylase content greater than 3 times the upper limit of normal serum amylase level (i.e., \>300 IU/L)(International Study Group for Pancreatic Fistulas (ISGPF) definition) or on or after postoperative week 1 drainage of more than 30 mL of fluid with an amylase level higher than 600 U/dL(Seoul National University Hospital (SNUH) definition). In addition, fistula severity was graded as A, B, C according to ISGPF clinical criteria as follows; grade A fistula - a transient, asymptomatic fistula with only elevated drain amylase levels and treatments or deviation in clinical management are not required; grade B fistula - a symptomatic, clinically apparent fistula requiring diagnostic evaluation and therapeutic management; and grade C fistula - a severe, clinically significant fistula requiring a major deviations in clinical management and unequivocal aggressive therapeutic interventions. Major pancreatic leakage was defined as drainage of more than 200 mL of fluid or the development of an intra-abdominal abscess.

Interventions

PROCEDUREclosed suction drainage of pancreatic duct

A Fr 5-8 silastic polyethylene pediatric feeding tube with multiple side-holes is inserted 2 cm into the pancreatic duct. The catheter exited via a small enterotomy in the jejunal loop of the distal portion of the hepaticojejunostomy. Totally externalized pancreatic stents were connected to the aspiration bag of a Jackson-Pratt drain to generate negative pressure or to a bile bag for natural drainage.

PROCEDUREnatural drainage of pancreatic duct

Natural drainage group

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* All patients who undergo duct-to-mucosa pancreaticojejunostomy reconstruction after pancreatoduodenectomy in our institution

Exclusion criteria

* less than 15 years old, or older than 85 years old

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With Pancreatic Fistulapostoperative 1 weekpancreatic fistula rate is stratified according to ISGPF criteria. Grade A; No major impact Grade B; Clinically relevant fistula, specific treatment may be required Grade C; Most severe form of fistula, with a high mortality rate

Secondary

MeasureTime frame
Severity of Pancreatic Fistulas2 years

Countries

South Korea

Participant flow

Participants by arm

ArmCount
Closed Suction Drainage Group
closed suction drainage group (CD group)
86
Natural Drainage Group
natural drainage group (ND group)
82
Total168

Baseline characteristics

CharacteristicNatural Drainage GroupClosed Suction Drainage GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
33 Participants27 Participants60 Participants
Age, Categorical
Between 18 and 65 years
49 Participants59 Participants108 Participants
Age, Continuous61.4 years
STANDARD_DEVIATION 11.1
60.7 years
STANDARD_DEVIATION 10.1
61.2 years
STANDARD_DEVIATION 10.6
Region of Enrollment
Korea, Republic of
82 participants86 participants168 participants
Sex: Female, Male
Female
27 Participants37 Participants64 Participants
Sex: Female, Male
Male
55 Participants49 Participants104 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 860 / 82
serious
Total, serious adverse events
0 / 860 / 82

Outcome results

Primary

Number of Patients With Pancreatic Fistula

pancreatic fistula rate is stratified according to ISGPF criteria. Grade A; No major impact Grade B; Clinically relevant fistula, specific treatment may be required Grade C; Most severe form of fistula, with a high mortality rate

Time frame: postoperative 1 week

ArmMeasureValue (NUMBER)
Closed Suction Drainage GroupNumber of Patients With Pancreatic Fistula9 participants
Natural Drainage GroupNumber of Patients With Pancreatic Fistula8 participants
Secondary

Severity of Pancreatic Fistulas

Time frame: 2 years

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026