Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula: An Open-label Randomized Controlled Trial

Conditions
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Pancreatic Fistula, Pancreaticoduodenectomy, Complication of Surgical Procedure

Intervention / Treatment
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* Procedure: Trans-Nasal Afferent Loop Decompression
* Procedure: Without Trans-Nasal Afferent Loop Decompression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trans-Nasal Afferent Loop Decompression Arm<br>Patients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy. | Procedure: Trans-Nasal Afferent Loop Decompression<br>* 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.<br>|
| Active Comparator: No Trans-Nasal Afferent Loop Decompression Arm<br>Patients will NOT receive trans-nasal afferent loop decompression after pancreaticoduodenectomy. | Procedure: Without Trans-Nasal Afferent Loop Decompression<br>* No decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pancreatic fistula (grade B+C) | Definition of postoperative pancreatic fistula was according ISGPS 2016 updates. | up to 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic fistula related complications | Including intra-abdominal infection and intra-abdominal fluid accumulation | up to 90 days after surgery | 
| Postoperative new-onset pulmonary complication | Including atelectasis, pleural effusion, pneumonitis | up to 14 days after surgery | 
| Other complications | Including postoperative hemorrhage, delayed gastric emptying, chyle leak, bile leak, sepsis, incision complication, deep vein thrombosis, pulmonary embolism, etc | up to 90 days after surgery | 
| Overall complication and severe complication | Overall complication (Clavien-Dindo ≥ grade I) and severe complication (Clavien-Dindo ≥ grade III) | up to 90 days after surgery | 
| Reintervention treatment | Number of patients with reintervention treatment for complications including percutaneous drainage, endoscopic procedure, angiographic procedure and reoperation | up to 90 days after surgery | 
| Mortality rate | Death for any reason | up to 90 days after surgery | 
| Length of postoperative stay | From surgery to discharge including ICU stay | up to 90 days after surgery | 
| Readmission | New admission within 90-days of discharge from hospital for any reason | up to 90 days after surgery |