Omitting Nasogastric Tube Decompression in Minimally Invasive Pancreaticoduodenectomy

NCT07370116 | Not Yet Recruiting Phase 2

• 1 other identifier: NCC2025C1365
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate two perioperative nasogastric tube strategies in patients undergoing laparoscopic pancreatoduodenectomy. The goal is to determine whether routine omission of a nasogastric tube is not worse than routine nasogastric tube placement in terms of overall complications and postoperative recovery. Participants will be randomly assigned to one of two groups. Each group will receive the assigned nasogastric tube strategy during and after surgery, and will be followed during the hospital stay and after discharge for up to postoperative 90 days. Information will be collected from routine clinical care, including discomfort score, symptoms, imaging or laboratory tests when clinically indicated, and postoperative outcomes. The main outcome of this study is the overall burden of postoperative complications within 30 days after surgery, measured using the Comprehensive Complication Index, which summarizes all complications into a single score. Secondary outcomes include rates of pancreas surgery-specific complications (such as delayed gastric emptying, pancreatic fistula, bile leak, bleeding, and chyle leak), other abdominal and pulmonary complications, and organ dysfunction (including kidney injury, sepsis, and new cardiac dysfunction). The study will also evaluate patient discomfort related to the nasogastric tube (pain/discomfort scores), the need for nasogastric tube reinsertion, postoperative recovery milestones (ability to resume oral intake and length of hospital stay), healthcare costs, and all-cause mortality at 30 and 90 days after surgery.

Conditions

Pancreaticoduodenectomy; Nasogastric Tube Decompression; Minimally Invasive Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Comprehensive Complication Index

  Comprehensive Complication Index calculates a weighted sum of complications graded by the Clavien-Dindo classification that occur within 30 days postoperatively to generate a continuous score from 0 (no complications) to 100 (death), quantifying the overall postoperative complication burden

  30 days postoperatively

Secondary Outcomes (9)

• pancreaticoduodenectomy-specific complications

  30 days postoperatively

• abdominal complications

  30 days postoperatively

• pulmonary complications

  30 days postoperatively

• comfort

  30 days postoperatively

• Time to tolerate oral intake (liquids/solids)

  Up to 90 days postoperatively

Study Arms (2)

routine nasogastric tube

ACTIVE COMPARATOR

standard nasogastric tube placement with the tube retained postoperatively

Procedure: nasogastric tube decompression

routine omission of the nasogastric tube

EXPERIMENTAL

avoidance of prophylactic nasogastric tube placement

Procedure: Omission of nasogastric tube decompression

Interventions

nasogastric tube decompression PROCEDURE

Nasogastric tube decompression means standard NGT placement with the tube retained postoperatively until the drainage volume is \<500 ml/day on postoperative day 3. Nasogastric tube placement will adhere to the following requirements: pre-insertion nasal patency assessment excluding the side with septal deviation or polyps, catheter pre-measurement from the apex nasi to the ear lobe and xiphoid process, and lubrication with liquid paraffin. After advancement into the pharynx, conscious patients will undergo repeated swallowing to facilitate passage, whereas unconscious patients will require laryngeal elevation with neck flexion to prevent tracheal intubation.

routine nasogastric tube

Omission of nasogastric tube decompression PROCEDURE

Omission of nasogastric tube decompression means avoidance of prophylactic NGT placement throughout the perioperative period. If intraoperative NGT insertion becomes necessary because of acute gastric dilatation, the tube should be removed before anesthesia emergence.

routine omission of the nasogastric tube

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 years and 75 years.
• Indication for MIPD confirmed by MDT evaluation.
• Ability to understand trial requirements and willingness to adhere to study protocols.
• Written informed consent obtained before registration.
• Curative-intent treatment consistent with international clinical guidelines.

You may not qualify if:

• Requirement of partial or total pancreatectomy or other palliative procedures, or presence of distant metastases (peritoneal, hepatic, distant nodal, or other organ involvement); therefore, these patients are not candidates for MIPD.
• American Society of Anaesthesiologists (ASA) Physical Status ≥ IV.
• Pregnant or breastfeeding women.
• Severe psychiatric disorders.
• History of other malignancy.
• Neoadjuvant chemoradiotherapy prior to surgery.
• Body mass index \>35 kg/m2.
• History of nasopharyngeal, gastric or oesophageal surgery.
• Preoperative gastrointestinal obstruction.
• Contraindications to nasogastric intubation, including recent caustic ingestion, oesophageal stricture/diverticulum, or maxillofacial trauma.
• Participation in any other clinical trials within 3 months.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: collaborator
• Shanghai Cancer Centre: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• People's Hospital of Chongqing: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Shandong Provincial Hospital: collaborator
• The Second Affiliated Hospital of the Army Medical University: collaborator
• West China Hospital: collaborator
• Shanxi Province Cancer Hospital: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Location

Study Officials

• Min Wang

  Department of Pancreatic and Gastric Surgery, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junzhe Zhuo

CONTACT

+86 18250336385; jz.zhuo@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Chief Physician

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years thereafter.
• Access Criteria: Researchers who provide a methodologically sound proposal may request access. Proposals will be reviewed by the study team. Access will be provided after execution of a data use agreement. Data will be accessed via a secure platform or institutional controlled-access repository.

Locations

CN (1)