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NCT Number: NCT04989868

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

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.

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Key information

Conditions

Pancreatic Fistula Complication of Surgical Procedure Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pancreaticoduodenectomy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans-Nasal Afferent Loop Decompression

Procedure

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.

Without Trans-Nasal Afferent Loop Decompression

Procedure

No decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.

Primary outcomes

  1. Postoperative pancreatic fistula (grade B+C)

    Time frame: up to 90 days after surgery

    Definition of postoperative pancreatic fistula was according ISGPS 2016 updates.

Secondary outcomes

  1. Pancreatic fistula related complications

    Time frame: up to 90 days after surgery

    Including intra-abdominal infection and intra-abdominal fluid accumulation

  2. Postoperative new-onset pulmonary complication

    Time frame: up to 14 days after surgery

    Including atelectasis, pleural effusion, pneumonitis

  3. Other complications

    Time frame: 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

  4. Overall complication and severe complication

    Time frame: up to 90 days after surgery

    Overall complication (Clavien-Dindo ≥ grade I) and severe complication (Clavien-Dindo ≥ grade III)

  5. Reintervention treatment

    Time frame: up to 90 days after surgery

    Number of patients with reintervention treatment for complications including percutaneous drainage, endoscopic procedure, angiographic procedure and reoperation

  6. Mortality rate

    Time frame: up to 90 days after surgery

    Death for any reason

  7. Length of postoperative stay

    Time frame: up to 90 days after surgery

    From surgery to discharge including ICU stay

  8. Readmission

    Time frame: up to 90 days after surgery

    New admission within 90-days of discharge from hospital for any reason

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2021
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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