Complication of Surgical Procedure, Pancreatic Fistula, Pancreaticoduodenectomy
Conditions
Brief summary
Postoperative pancreatic fistula (POPF) is a major complication and an important cause of mortality after pancreaticoduodenectomy (PD). Trans-nasal afferent loop decompression technique (TNALD) may reduce the rate of POPF based on our previous retrospective study. The aim of this open-label randomized controlled trial is to determine whether TNALD is a protective factor against the development of POPF after PD.
Detailed description
In our previous retrospective study, decompression of the afferent jejunal and pancreatic and biliary anastomoses with a special nasogastric tube and postoperative continuous closed negative pressure suction was shown to be associated with a reduction in overall POPF rate from 39% to 27% after PD. However, TNALD has the potential theoretical risk of increased morbidity including pulmonary complications and delayed gastric emptying. The objective of this prospective randomized study is to evaluate the impact of trans-nasal afferent loop decompression on the incidence of complications after PD, especially POPF rate according to International Study Group of Pancreatic Surgery (ISGPS) 2016 updates. We hypothesize that the TNALD may prevent the development of POPF after PD. This study randomizes patients to TNALD versus no TNALD group. Subgroup analysis of the outcomes in different POPF risk groups is also planned.
Interventions
PROCEDURETrans-Nasal Afferent Loop Decompression
A 14Fr silicon tube with multiple side holes within the range of 15 cm from the tip will be placed into the afferent jejunal limb with its end close to the pancreaticojejunostomy (\<3 cm) during the surgery. Continuous closed negative-pressure suction will be applied to that tube for 72 hours and after that the nasogastric tube will be removed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
PROCEDUREWithout Trans-Nasal Afferent Loop Decompression
No decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for elective open pancreaticoduodenectomy with Child reconstruction * Age \> 18 years and ≤ 85 years * Full agreement to participate and written informed consent is given
Exclusion criteria
* Emergent pancreaticoduodenectomy * Laparoscopic pancreaticoduodenectomy or robotic pancreaticoduodenectomy, including transition to open approach * Participant in other trials of pancreaticoduodenectomy with interfering interventions and/or endpoints * Patient with severe co-morbidity(s) before surgery, including severe insufficiency in kidney, heart and/or liver, etc. * Patient had medication history of corticosteroids over 3 days during last 30 days before surgery * No need for pancreaticojejunostomy during pancreaticoduodenectomy (i.e. past left pancreatectomy, pancreaticogastrostomy, etc.), or pancreatic anastomosis cannot be reconstructed for any reason * External stenting is used during the surgery for any reason * Nasogastric tube is inserted and kept for postoperative gastric decompression * In any situation that the placement of afferent loop decompression tube is medically inappropriate or not infeasible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pancreatic fistula (grade B+C) | up to 90 days after surgery | Definition of postoperative pancreatic fistula was according ISGPS 2016 updates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative new-onset pulmonary complication | up to 14 days after surgery | Including atelectasis, pleural effusion, pneumonitis |
| Other complications | up to 90 days after surgery | Including postoperative hemorrhage, delayed gastric emptying, chyle leak, bile leak, sepsis, incision complication, deep vein thrombosis, pulmonary embolism, etc |
| Overall complication and severe complication | up to 90 days after surgery | Overall complication (Clavien-Dindo ≥ grade I) and severe complication (Clavien-Dindo ≥ grade III) |
| Pancreatic fistula related complications | up to 90 days after surgery | Including intra-abdominal infection and intra-abdominal fluid accumulation |
| Mortality rate | up to 90 days after surgery | Death for any reason |
| Length of postoperative stay | up to 90 days after surgery | From surgery to discharge including ICU stay |
| Readmission | up to 90 days after surgery | New admission within 90-days of discharge from hospital for any reason |
| Reintervention treatment | up to 90 days after surgery | Number of patients with reintervention treatment for complications including percutaneous drainage, endoscopic procedure, angiographic procedure and reoperation |
Countries
China
Outcome results
None listed