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

Nanjing Medical University

Status: Completed

Conditions: Pancreatic Fistula; Complication of Surgical Procedure; Pancreaticoduodenectomy

Treatments: Procedure: Trans-Nasal Afferent Loop Decompression; Procedure: Without Trans-Nasal Afferent Loop Decompression

Study type: Interventional

Funder types: Other

Identifiers

NCT04989868

TNALD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 299 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

299 participants in 2 patient groups

Trans-Nasal Afferent Loop Decompression Arm

Experimental group

Description:

Patients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.

Treatment:

Procedure: Trans-Nasal Afferent Loop Decompression

No Trans-Nasal Afferent Loop Decompression Arm

Active Comparator group

Description:

Patients will NOT receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.

Treatment:

Procedure: Without Trans-Nasal Afferent Loop Decompression