Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy

NCT03984734 | Completed

• 1 other identifier: QUANUPAD
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a randomized unblinded single-centre trial. The main hypothesis of the study was that pylorus-preserving pancreatoduodenectomy reduces the incidence of delayed gastric emptying . Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of surgical technique: pylorus-preserving pancreatoduodenectomy versus stardard pancreatoduodenectomy with antrectomy. The primary endpoint was the incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative morbidity and mortality, length of hospital stay, and nutritional status and quality of life.

Conditions

Delayed Gastric Emptying

Keywords

Delayed Gastric Emptying; Pylorus-preserving pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of DGE

  Nasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day

  within the first 90 days after surgery

Secondary Outcomes (3)

• Postoperative morbidity

  within the first 90 days after surgery

• Postoperative mortality

  within the first 90 days after surgery

• Length of hospital stay

  within the first 90 days after surgery

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients undergoing pancreatoduodenectomy with antrectomy

Procedure: Pancreatoduodenectomy with antrectomy

Study group

EXPERIMENTAL

Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy

Procedure: Pylorus-preserving pancreatoduodenectomy

Interventions

Pancreatoduodenectomy with antrectomy PROCEDURE

Control group

Pylorus-preserving pancreatoduodenectomy PROCEDURE

Study group

Eligibility Criteria

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

You may qualify if:

• Patients who underwent surgical resection of the head of the pancreas at the authors' institution from August 2003 to August 2008. Adults of either sex aged over 18 years were included.

You may not qualify if:

• Associated resections of other organs, except for the portal or superior mesenteric vein
• Total pancreatectomy
• Previous gastrectomy or other gastric surgeries
• Neoadjuvant treatment
• Liver cirrhosis.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Related Publications (1)

• Busquets J, Martin S, Secanella L, Sorribas M, Cornella N, Altet J, Pelaez N, Bajen M, Carnaval T, Videla S, Fabregat J. Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD). Langenbecks Arch Surg. 2022 Sep;407(6):2247-2258. doi: 10.1007/s00423-022-02583-9. Epub 2022 Jul 4.

  PMID: 35786739 DERIVED

MeSH Terms

Conditions

Gastroparesis

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Juan Fabregat Prous, Dr.

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff surgeon Bellvitge Universitary Hospital

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: June 13, 2019
• Study Start: August 1, 2003
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: June 13, 2019

Record last verified: 2019-06